%0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e66379 %T Perceptions of Stigma Among Patients With Hepatitis B in Germany: Cross-Sectional Survey %A Zimmermann,Bettina M %A Willem,Theresa %A Rost,Michael %A Matthes,Nina %A Buyx,Alena %K infectious diseases %K infection %K contaminate %K septic shock %K hepatitis B %K social stigma %K stigmatize %K discrimination %K prejudice %K social factor %K social disparity %K social inequality %K social inequity %K Germany %D 2025 %7 13.6.2025 %9 %J JMIR Form Res %G English %X Background: Many studies find associations between hepatitis B and stigma, but studies from the Western European context are lacking. Based on available studies, we hypothesized that younger age, higher education, male gender, higher privacy needs, and non-German mother tongue were positively associated with perceived hepatitis B–related stigma. Objective: This study aims to describe the prevalence of perceived social stigma among patients with hepatitis B in Germany and to assess what factors are associated with perceptions of hepatitis B–related stigma. Methods: Applying the short version of the Berger stigma scale, we surveyed 195 patients with hepatitis B about their perceptions of hepatitis B–related stigma, privacy needs, and demographic variables through a paper-based questionnaire. Venue-based recruitment of adult patients diagnosed with acute or chronic hepatitis B was implemented at 3 clinical centers in Germany. Patients who could not read German were excluded from the study. Results: From the 195 valid questionnaires, 45.1% (88/195) of participants identified as female, 36.6% (71/195) had a high school diploma, and 56.9% (111/195) reported a mother tongue other than German. The mean (SD) stigma score throughout the sample was 5.52 (6.02; range 0-24) and the median was 3.50 (IQR=9.75). Regression analysis revealed that non-German mother tongue, individual data privacy needs, and participants’ secrecy regarding their hepatitis B diagnosis independently predicted perceived hepatitis B-related stigma. More precisely, the higher the data privacy need and the more secret the hepatitis B diagnosis, the higher the perceived stigma, and perceived stigma was higher for patients with a non-German mother tongue. Age, gender, and education were no predictors of perceived stigma. Conclusions: The surveyed patients with hepatitis B in Germany reported lower levels of hepatitis B–related stigma than found in other studies conducted in Asian countries. The association with non-German mother tongue indicates an important cultural and social component in the perception of stigma. Community-based interventions and the sensibilization of health care professionals might help overcome perceptions of stigma among hepatitis B–affected populations. %R 10.2196/66379 %U https://formative.jmir.org/2025/1/e66379 %U https://doi.org/10.2196/66379 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e63811 %T Relationship of Hair Cortisol Concentration With Perceived and Somatic Stress Indices: Cross-Sectional Pilot Study %A Bergquist,Sharon H %A Wang,Danyang %A Pearce,Brad %A Smith,Alicia K %A Hankus,Allison %A Roberts,David L %A Moore,Miranda A %K hair cortisol concentration %K perceived stress %K somatic stress %K resilience %K physiological stress %D 2025 %7 11.6.2025 %9 %J JMIR Form Res %G English %X Background: Hair cortisol is an emerging biomarker of chronic stress. However, the psychological and physiological aspects of chronic stress that are reflected in hair cortisol concentration (HCC) have not been fully determined. Since physiological responses to stress do not always align with how stress is perceived, we conducted this study to evaluate whether HCC correlates with neuroendocrine stress indicators or stress perceptions. Objective: This study aimed to evaluate whether subjective (Perceived Stress Scale and Connor-Davidson Resilience Scale) and objective (plasma cortisol/dehydroepiandrosterone-sulfate [DHEA-S] and cortisol/high-sensitivity C-reactive protein) determinants of stress and resilience correlate with HCC. Methods: In this cross-sectional pilot validity study, scatter plots and Spearman correlation coefficients were used to measure the direction and magnitude of the relationship between stress and resilience measures among 51 predominantly male participants. In a subset (n=24), we performed a step-wise regression modeling approach to isolate the association of perceived and somatic stress on hair cortisol. Results: Bivariate correlations showed a weak inverse association of HCC with Perceived Stress Scale (Spearman correlation ρ=−0.14, P=.52) and a stronger positive association with somatic neuroendocrine stress indices cortisol/DHEA-S (ρ=0.24, P=.25) and cortisol/high-sensitivity C-reactive protein (ρ=0.21, P=.35). In linear regression models, HCC showed the strongest association with cortisol/DHEA-S (r2=0.10, P=.13, 1.01β 1.01, 95% CI 0.99‐1.01). This relationship remained when age, gender, hair washing frequency, hair dye or bleach use, diabetes mellitus, obesity, cardiovascular disease, anxiety, medication use, and endocrine disorders were considered. Conclusions: Our results do not indicate a statistically significant association (at the P<.05 threshold) between HCC and stress perception or somatic measures of neuroendocrine response. %R 10.2196/63811 %U https://formative.jmir.org/2025/1/e63811 %U https://doi.org/10.2196/63811 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 10 %N %P e62876 %T A Culturally Tailored Physical Activity Intervention for Hispanic Adults Living With Type 2 Diabetes: Pre-Post Pilot Feasibility Study %A Loya,Julio %A Garcia,David O %A Maldonado,Adriana %A Villavicencio,Edgar %K type 2 diabetes %K physical activity %K Hispanic adults %K intervention %K diabetes mellitus %K metabolic disease %K United States %K lifestyle modification %K pilot intervention %K community-engaged %K self-efficacy %D 2025 %7 10.6.2025 %9 %J JMIR Diabetes %G English %X Background: Type 2 diabetes mellitus (T2DM) is a metabolic disease that affects over 38 million adults in the United States, who are disproportionately Hispanic. Objective: This study describes the development and implementation of Salud Paso por Paso, a culturally tailored and linguistically appropriate intervention to increase engagement in physical activity (PA) for Hispanic adults living with T2DM. Methods: Participants were enrolled in a 6-week pre-post pilot test of a culturally tailored intervention that included sessions covering different aspects of PA and T2DM. Participants were recruited at a local free clinic. Nonparametric paired-sample Wilcoxon signed-rank tests were used to examine differences between pre- and postintervention measures. Results: Twenty-one participants were recruited, and 19 (90.5%) completed the intervention. Participants significantly increased average hours spent in moderate PA, by 3.16 hours (from 4.73, SD 3.79 minutes to 9.63, SD 6.39 minutes; Z=−3.52; P<.001), average steps per week (from 23,006.38, SD 14,357.13 steps to 43,000.81, SD 30,237.17 steps; Z=−2.79; P=.005), and minutes per week of PA (from 105.94, SD 72.23 minutes to 224.19, SD 167.85 minutes; Z=−3.36; P<.001). Conclusions: Developing effective culturally tailored interventions that can ameliorate the deleterious effects of T2DM in Hispanic adults is an important strategy to promote health equity. The Salud Paso por Paso intervention is an effective way to promote PA in Hispanic adults living with T2DM. %R 10.2196/62876 %U https://diabetes.jmir.org/2025/1/e62876 %U https://doi.org/10.2196/62876 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e69138 %T Prevalence of Multiple Chronic Conditions Among Adults in the All of Us Research Program: Exploratory Analysis %A Li,Xintong %A Dreisbach,Caitlin %A Gustafson,Carolina M %A Murali,Komal Patel %A Koleck,Theresa A %K electronic health records %K multiple chronic conditions %K prevalence %K secondary data analysis %K United States %K All of Us %D 2025 %7 12.5.2025 %9 %J JMIR Form Res %G English %X Background: The growing prevalence of multiple chronic conditions (MCC) has significant impacts on health care systems and quality of life. Understanding the prevalence of MCC throughout adulthood offers valuable insights into the evolving burden of chronic diseases and provides strategies for more effective health care outcomes. Objective: This study estimated the prevalence and combinations of MCC among adult participants enrolled in the All of Us (AoU) Research Program, especially studying the variations across age categories. Methods: We conducted an exploratory analysis using electronic health record (EHR) data from adult participants (N=242,828) in the version 7 Controlled Tier AoU Research Program data release. Data analysis was conducted using Python in a Jupyter notebook environment within the AoU Researcher Workbench. Descriptive statistics included condition frequencies, the number of chronic conditions per participant, and prevalence according to age categories. The presence of a chronic condition was determined by documentation of one or more ICD-10 (International Statistical Classification of Diseases, Tenth Revision) codes for the respective condition. Age categories were established and aligned with diagnosis dates and stages of adulthood (early adulthood: 18-39 years; middle adulthood: 40-49 years; late middle adulthood: 50-64 years; late adulthood: 65-74 years; advanced old age: 75-89 years). Results: Our findings demonstrated that approximately 76% (n=183,753) of AoU participants were diagnosed with MCC, with over 40% (n=98,885) having 6 or more conditions and prevalence increasing with age (from 33.78% in early adulthood to 68.04% in advanced old age). The most frequently occurring MCC combinations varied by age category. Participants aged 18-39 years primarily presented mental health–related MCC combinations (eg, anxiety and depressive disorders; n=845), whereas those aged 40-64 years frequently had combinations of physical conditions such as fibromyalgia, chronic pain, fatigue, and arthritis (204 in middle adulthood and 457 in late middle adulthood). In late adulthood and advanced old age, hyperlipidemia and hypertension were the most commonly occurring MCC combinations (n=200 and n=59, respectively). Conclusions: We report notable prevalence of MCC throughout adulthood and variability in MCC combinations by age category in AoU participants. The significant prevalence of MCC underscores a considerable public health challenge, revealed by distinct condition combinations that shift across different life stages. Early adulthood is characterized predominantly by mental health conditions, transitioning to cardiometabolic and physical health conditions in middle, late, and advanced ages. These findings highlight the need for targeted, innovative care modalities and population health initiatives to address the burden of MCC throughout adulthood. %R 10.2196/69138 %U https://formative.jmir.org/2025/1/e69138 %U https://doi.org/10.2196/69138 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 11 %N %P e68355 %T Analyzing Satellite Imagery to Target Tuberculosis Control Interventions in Densely Urbanized Areas of Kigali, Rwanda: Cross-Sectional Pilot Study %A Faccin,Mauro %A Geenen,Caspar %A Happaerts,Michiel %A Ombelet,Sien %A Migambi,Patrick %A André,Emmanuel %K tuberculosis %K Rwanda %K satellite image %K TB %K PCR testing %K PCR %K questionnaire %K satellite %K active case-finding %K diagnostic %K urban %K Africa %K TB screening %K ACF %K polymerase chain reaction %D 2025 %7 24.4.2025 %9 %J JMIR Public Health Surveill %G English %X Background: Early diagnosis and treatment initiation for tuberculosis (TB) not only improve individual patient outcomes but also reduce circulation within communities. Active case-finding (ACF), a cornerstone of TB control programs, aims to achieve this by targeting symptom screening and laboratory testing for individuals at high risk of infection. However, its efficiency is dependent on the ability to accurately identify such high-risk individuals and communities. The socioeconomic determinants of TB include difficulties in accessing health care and high within-household contact rates. These two determinants are common in the poorest neighborhoods of many sub-Saharan cities, where household crowding and lack of health-care access often coincide with malnutrition and HIV infection, further contributing to the TB burden. Objective: In this study, we propose a new approach to enhance the efficacy of ACF with focused interventions that target subpopulations at high risk. In particular, we focus on densely inhabited urban areas, where the proximity of individuals represents a proxy for poorer neighborhoods with enhanced contact rates. Methods: To this end, we used satellite imagery of the city of Kigali, Rwanda, and computer-vision algorithms to identify areas with a high density of small residential buildings. We subsequently screened 10,423 people living in these areas for TB exposure and symptoms and referred patients with a higher risk score for polymerase chain reaction testing. Results: We found autocorrelation in questionnaire scores for adjacent areas up to 782 meters. We removed the effects of this autocorrelation by aggregating the results based on H3 hexagons with a long diagonal of 1062 meters. Out of 324 people with high questionnaire scores, 202 underwent polymerase chain reaction testing, and 9 people had positive test results. We observed a weak but statistically significant correlation (r=0.28; P=.04) between the mean questionnaire score and the mean urban density of each hexagonal area. Conclusions: Nine previously undiagnosed individuals had positive test results through this screening program. This limited number may be due to low TB incidence in Kigali, Rwanda, during the study period. However, our results suggest that analyzing satellite imagery may allow the identification of urban areas where inhabitants are at higher risk of TB. These findings could be used to efficiently guide targeted ACF interventions. %R 10.2196/68355 %U https://publichealth.jmir.org/2025/1/e68355 %U https://doi.org/10.2196/68355 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e69113 %T Impact of Acute Respiratory Infections on Medical Absenteeism Among Military Personnel: Retrospective Cohort Study %A M,Premikha %A Goh,Jit Khong %A Ng,Jing Qiang %A Mutalib,Adeliza %A Lim,Huai Yang %K respiratory infections %K military %K epidemiology %K public health %K surveillance %D 2025 %7 18.4.2025 %9 %J JMIR Form Res %G English %X Background: Acute respiratory infections (ARI) are a significant challenge in military settings due to close communal living, which facilitates the rapid transmission of pathogens. A variety of respiratory pathogens contribute to ARI, each varying in prevalence, severity, and impact on organizational productivity. Understanding and mitigating the impact of ARI is critical for optimizing the health of military personnel and maintaining organizational productivity. Objective: This retrospective study of surveillance data aims to identify pathogens causing ARI among servicemen and determine which pathogens contribute most to medical absenteeism, defined as the combined duration of the issued medical certificate and light duty. Methods: From September 2023 to August 2024, anonymous nasopharyngeal swabs (BioFire FilmArray Respiratory Panel) were collected from Singapore Armed Forces servicemen presenting with ARI symptoms after a doctor’s consultation at a local military camp’s medical centre. The presence of fever and duration of medical certificate and light duty were self-reported by Singapore Armed Forces servicemen. Results: A total of 1095 nasopharyngeal swabs were collected, of which 608 (55.5%) tested positive. The most common respiratory pathogen was human rhinovirus/enterovirus (HRV/HEV) in 303 (27.7%) individuals. The highest proportions of fever were observed in servicemen with influenza (62.8%, 27/43), SARS-CoV-2 (34.3%, 12/35), and parainfluenza (31.6%, 12/38). The odds of patients with influenza that have fever was 5.8 times higher than those of patients infected with HRV/HEV (95% CI 2.95‐11.40, P<.001). The median duration of medical certificate, light duty, and medical absenteeism were 0 (IQR 0), 2 (IQR 2) and 2 (IQR 0) days, respectively. The odds of patients with influenza having a medical certificate with duration ≥1 day was 5.34 times higher than those in patients with HRV/HEV (95% CI 2.63‐10.88, P<.001). No significant differences in the duration of medical absenteeism were found between HRV/HEV and other pathogens. Conclusions: Compared to HRV/HEV, influenza infections were significantly associated with longer medical certificate duration. Nonetheless, there were no significant differences in the overall duration of medical absenteeism across pathogens, as servicemen infected with other pathogens were given light duty instead. These findings emphasize the need for pathogen-agnostic ARI measures. While influenza vaccinations are already mandatory for servicemen in local military camps, encouraging additional public health measures (eg, mask-wearing among symptomatic servicemen, COVID-19 vaccinations, therapeutics) can further reduce ARI incidence, minimize the duration of medical absenteeism, and mitigate the impact on organizational productivity. %R 10.2196/69113 %U https://formative.jmir.org/2025/1/e69113 %U https://doi.org/10.2196/69113 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e58436 %T Improving Health and Well-Being of People With Post–COVID-19 Consequences in South Africa: Situation Analysis and Pilot Intervention Design %A Glover,Nicole Audrey %A Sathar,Farzana %A Mokome,Pride %A Mathabela,Nkululeko %A Taleni,Sipokazi %A van Blydenstein,Sarah Alexandra %A Mekota,Anna-Maria %A Charalambous,Salome %A Rachow,Andrea %A Ivanova,Olena %K post–COVID-19 %K rehabilitation %K support %K quality of life %K group care %K well-being %K South Africa %K COVID-19 %K situation analysis %K pilot %K intervention %K context-adapted %K physical health %K mental health %K cross-sectional %K mixed method %K questionnaire %K in-depth %K interviews %K survey %K focus group %K quantitative %K qualitative %K support group %K hospital %K patients %K health care workers %K health worker %D 2025 %7 10.4.2025 %9 %J JMIR Form Res %G English %X Background: Multisystemic complications post–COVID-19 infection are increasingly described in the literature, yet guidance on the management remains limited. Objectives: This study aimed to assess the needs, preferences, challenges, and existing interventions for individuals with post–COVID-19 symptoms. Based on this, we aimed to develop a context-adapted intervention to improve the overall health and well-being of individuals with post–COVID-19 complications. Methods: We conducted a cross-sectional mixed-methods situation analysis assessing the needs, preferences, challenges, and existing interventions for patients with post–COVID-19 symptoms. We collected data through questionnaires, semistructured in-depth interviews, and focus group discussions (FGDs) from individuals diagnosed with COVID-19 within the previous 18-month period and health care providers who managed patients with COVID-19 in both inpatient and outpatient settings. Quantitative data were summarized using descriptive statistics, qualitative data were transcribed, and deductive analysis focused on suggestions for future interventions. Findings guided the development of a group intervention. Results: We conducted 60 questionnaires, 13 interviews, and 3 FGDs. Questionnaires showed limited knowledge of post–COVID-19 complications at 26.7% (16/60). Of those who received any rehabilitation for COVID-19 (19/60, 31.7%), 94.7% (18/19) found it helpful for their recovery. Just over half (23/41, 56%) of those who did not receive rehabilitation reported that they would have liked to. The majority viewed rehabilitation as an important adjunct to post–COVID-19 care (56/60, 93.3%) and that support groups would be helpful (53/60, 88.3%). Qualitative results highlighted the need for mental health support, structured post–COVID-19 follow-up, and financial aid in post–COVID-19 care. Based on the insights from the situation analysis, the theory of change framework, and existing post–COVID-19 evidence, we designed and conducted a pilot support group and rehabilitation intervention for individuals with post–COVID-19 complications. Our main objective was to assess the change in physical and psychological well-being pre- and postintervention. The intervention included 8 weekly themed group sessions supplemented by home tasks. Effectiveness of the intervention was evaluated by questionnaires pre- and postintervention on post–COVID-19 symptoms, quality of life with the EuroQoL 5-Dimension 5-Level, short Warwick-Edinburgh Mental Wellbeing Scale, and physical function by spirometry and 1-minute sit-to-stand test. We also assessed the feasibility and acceptability of the intervention by questionnaires and semistructured in-depth interviews. The intervention outcome analysis is yet to be conducted. Conclusions: Insights from patients and health care providers on the characteristics of post–COVID-19 complications helped guide the development of a context-adapted intervention program with potential to improve health and well-being post–COVID-19. %R 10.2196/58436 %U https://formative.jmir.org/2025/1/e58436 %U https://doi.org/10.2196/58436 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e66970 %T The Monthly Cycling of Food Insecurity in Latinas at Risk for Diabetes: Methods, Retention, and Sample Characteristics for a Microlongitudinal Design %A Bermúdez-Millán,Angela %A Pérez-Escamilla,Rafael %A Segura-Pérez,Sofia %A Grady,James %A Feinn VI,Richard S %A Agresta,Hanako %A Kim,Dean %A Wagner,Julie Ann %K food insecurity %K monthly cycling %K type 2 diabetes risk %K quantitative methods %K Latinas %K endocrinology %K nutrition %K nutrition assistance %K micro-longitudinal design %D 2025 %7 28.3.2025 %9 %J JMIR Form Res %G English %X Background: Food insecurity (FI) is a risk factor for type 2 diabetes (T2D) that disproportionately affects Latinas. We conducted a microlongitudinal study to examine the relationship of monthly cycling of FI and diabetes risk factors. Objective: This study aimed to determine the quantitative methodology, recruitment and retention strategies, predictors of retention across time, and baseline sample demographics. Methods: Participants were adult Latinas living in Hartford, Connecticut who were recruited through a community agency, invited to participate if they were receiving Supplementary Nutrition Assistance Program (SNAP) benefits, screened positive for FI using the 2-item Hunger Vital Sign Screener, and had elevated risk factors for T2D using the American Diabetes Association risk factor test. Using a microlongitudinal design, we collected data twice per month for 3 months (week 2, which is a period of food budget adequacy; and week 4, which is a period of food budget inadequacy) to determine if the monthly cycling of FI was associated with near-term diabetes risk (fasting glucose, fructosamine, and glycosylated albumin) and long-term risk (BMI, waist circumference, and glycated hemoglobin) markers. We determined whether household food inventory, psychological distress, and binge eating mediated associations. We examined Health Action Process Approach model constructs. To assess the relationship between monthly cycling of FI with diabetes risk markers, we used repeated measures general linear mixed models. To assess the role of mediators, we performed a causal pathway analysis. Results: Participant enrollment was from April 1, 2021 to February 21, 2023. A total of 87 participants completed 420 assessments or a mean of 4.83 (SD 2.02) assessments. About half (47/87, 54%) of the sample self-identified as Puerto Rican, mean age was 35.1 (SD 5.8) years, with 17.1 (SD 11.6) years in the mainland United States. Just under half (41/87, 47.1%) spoke Spanish only, 69% (60/87) had no formal schooling, and 31% (27/87) had less than eighth grade education. Modal household size was 4 including 2 children; 44.8% (39/87) were not living with a partner. About half (47/87, 54%) were unemployed, 63.2% (55/87) reported a monthly income 80% of the time throughout the study period. A significant increase in time in range was observed within 3 months and sustained over 12 months. HbA1c decreased significantly in 3 months and stayed lower throughout the 12-month period. Mean HbA1c levels decreased by 2.8% at 6 months (P<.001) and 3.2% at 12 months (P<.001). A total of 12 diabetes-related hospitalizations were reported during the study period. No cases of diabetic ketoacidosis or episodes of severe hypoglycemia occurred. Conclusions: Significant and meaningful improvements in key glycemic indices indicate the potential feasibility and impact of a CGM among people living with T1D in Rwanda. Future studies could be designed to include pre- and postintervention analysis to determine the effectiveness in terms of complications and costs. %R 10.2196/64585 %U https://formative.jmir.org/2025/1/e64585 %U https://doi.org/10.2196/64585 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e60051 %T A Very Low–Carbohydrate Program in Adults With Metabolic Dysfunction–Associated Steatotic Liver Disease and Phospholipase Domain–Containing Protein 3 Risk Genotype: Pre-Post Intervention Study %A Saslow,Laura R %A Krinock,Jamie %A O'Brien,Alison %A Raymond,Kaitlyn %A Bayandorian,Hovig %A Moskowitz,Judith T %A Daubenmier,Jennifer %A Oliveri,Antonino %A Marriott,Deanna J %A Griauzde,Dina H %A Speliotes,Elizabeth K %K metabolic dysfunction–associated steatotic liver disease %K ketogenic diet %K low carbohydrate %K adult %K genotype %K insulin %K insulin resistance %K metabolic dysfunction %K dietary pattern %K type 2 diabetes %K T2DM %K single-arm pilot trial %K liver function test %K genome %K non-alcoholic fatty liver disease %D 2025 %7 10.1.2025 %9 %J JMIR Form Res %G English %X Background: Insulin resistance and the G allele of rs738409 interact to create a greater risk of metabolic dysfunction–associated steatotic liver disease. Objective: This study aims to confirm that one promising way to reduce insulin resistance is by following a very low–carbohydrate (VLC) dietary pattern. Methods: Adults with rs738409-GG or -CG with liver steatosis and elevated liver function tests, were taught an ad libitum VLC diet, positive affect and mindful eating skills, goal setting, and self-monitoring and given feedback and coaching for 4 months. We measured liver steatosis, anthropometric, serum metabolic diet adherence, and quality of life measures. Results: In this small pilot trial, of the 11 participants enrolled, 9 (82%) participants completed outcomes. All 11 participants viewed at least 1 session of the intervention, and 8 (73%) participants viewed at least half of the sessions. Among the 9 participants who provided 4-month self-report information, intervention satisfaction was high (mean 6.22, 95% CI 5.58-6.85), with 5 (56%) participants rating the intervention the top score, and 4 (44%) participants reporting they did not plan to stop following the VLC diet. Across participants with a 4-month hepatic liver fat percent measurement, the percent change in liver fat was −33.17% (95% CI −86.48 to 20.14), and in only the participants who were adherent to the eating pattern, the percent change in liver fat was −53.12% (95% CI −71.25 to −34.99). Amongst participants with a 4-month hepatic liver fat percent measurement, 6 out of 8 (75%) participants were considered responders, with a relative decline in liver fat ≥30%, and of the 9 participants with a 4-month body weight, 9 (100%) participants lost ≥5% of their body weight. There were no serious adverse events. Conclusions: Results suggest the feasibility, acceptability, and preliminary efficacy of the VLC intervention in adults with higher genetic risk for metabolic dysfunction–associated steatotic liver disease, although there is a need for further studies given the small sample size and the high risk of substantial biases in this small pilot study. %R 10.2196/60051 %U https://formative.jmir.org/2025/1/e60051 %U https://doi.org/10.2196/60051 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e66430 %T Psychedelic Art and Implications for Mental Health: Randomized Pilot Study %A Peng,Mary L %A Monin,Joan %A Ovchinnikova,Polina %A Levi,Amanda %A McCall,Terika %+ Department of Orthopedics and Sports Medicine, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA, 02115, United States, 1 (617) 355 6021, marypeng@hms.harvard.edu %K digital art %K mental health %K psychedelic art %K well-being %K pilot trial %K digital health tool %K art therapy %D 2024 %7 3.12.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Psychedelic art (PA) emerged in the 1960s during the psychedelic era; then characterized by visuals induced by the ingestion of psychedelic drugs, it is now an art form known for its vibrant colors, distorted forms, and intricate patterns. Building upon the existing research on art viewing as an effective means to improving physiological and psychological well-being, viewing PA is postulated to evoke positive emotions and provide a meditative experience, contributing to improved mental well-being. Objective: This study aims to investigate how digitally rendered PA influences viewers’ perceived emotional, mental, and physical states compared to imagery of natural scenery, offering insights into potential applications in mental health care and well-being. Methods: Overall, 102 participants age 18 to 35 years were randomly assigned to either the experimental group viewing 300 seconds of PA imagery (50/102, 49%) or the control group viewing 300 seconds of scenic imagery (52/102, 51%), after which every participant completed a survey that gathered qualitative data on the perceived impact of viewing their given imagery on their physical, mental, and emotional states through open-ended questions. Thematic analysis was conducted to identify the patterns of experiences reported by the participants. Results: Qualitative analysis unveiled a greater intensity and diversity of emotional, mental, and physical impacts induced by PA compared to natural scenery, including the sense of relaxation and peace, anxiety and stress alleviation, joy, thrill and sense of euphoria, sensations of awe and wonder, hypnotizing effect, holistic meditative effect, provocation of creative thoughts, induced hyperawareness of bodily states, and transitions from induced overstimulation or anxious thoughts to feelings of calmness. Conclusions: The preliminary findings of this study suggest that PA is a rich and complex form of visual art that has the potential to facilitate healing and promote well-being and mental health. PA presents promising avenues for integration into mental health care, therapeutic practices, digital health, health care environment, and medical research. %M 39626224 %R 10.2196/66430 %U https://formative.jmir.org/2024/1/e66430 %U https://doi.org/10.2196/66430 %U http://www.ncbi.nlm.nih.gov/pubmed/39626224 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e60674 %T Evaluating a Virtual Reality Game to Enhance Teen Distracted Driving Education: Mixed Methods Pilot Study %A Peterson,Colleen M %A Visclosky,Timothy %A Flannagan,Carol A %A Mahajan,Prashant %A Gabanyicz,Andrew %A Bouchard,Jean-Jacques %A Cervantes,Vincent %A Gribbin,William %A Hashikawa,Andrew Nobuhide %+ Michigan Medicine-Department of Emergency Medicine, University of Michigan, NCRC B10-G080, 2800 Plymouth Road, Ann Arbor, MI, 48109-2800, United States, 1 734 936 9312, drewhash@umich.edu %K safety %K virtual reality %K VR %K distracted driving %K intervention %K inattention %K smartphone %K novice drivers %K risky driving %K mobile phone %K awareness %K game %K driving education %K gamification %K adolescent %D 2024 %7 26.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Inexperienced adolescent drivers are particularly susceptible to engaging in distracted driving behaviors (DDBs) such as texting while driving (TWD). Traditional driver education approaches have shown limited success in reducing motor vehicle crashes among young drivers. Objective: We tested an innovative approach to help address the critical issue of DDB among teenagers. We investigated the effectiveness of using a novel virtual reality (VR) game “Distracted Navigator” to educate novice teenage drivers about DDB. Methods: The game consisted of maneuvering a spaceship around asteroids while engaging in simulated DDB (eg, inputting numbers into a keypad). A physician-facilitated discussion, based on the theory of planned behavior, linked gameplay to real-life driving. Teenagers were recruited for the in-person study and randomly assigned at the block level to intervention (VR gameplay or discussion) and control groups (discussion only), approximating a 2:1 ratio. Unblinded, bivariate statistical analyses (all 2-tailed t tests or chi-square tests) and regression analyses measured programming impact on TWD-related beliefs and intentions. Content analysis of focus group interviews identified thematic feedback on the programming. Results: Of the 24 participants, 15 (63%) were male; their ages ranged from 14 to 17 (mean 15.8, SD 0.92) years, and all owned cell phones. Compared to the control group (n=7, 29%), the intervention group (n=17, 71%) was more likely to report that the programming had positively changed how they felt about texting and driving (?218=–8.3; P=.02). However, specific TWD attitudes and intentions were not different by treatment status. Irrespective of treatment, pre- and postintervention scores indicated reduced confidence in safely TWD (ie, perceived behavioral control; β=–.78; t46=–2.66; P=.01). Thematic analysis revealed the following: (1) the VR gameplay adeptly portrayed real-world consequences of texting and driving, (2) participants highly valued the interactive nature of the VR game and discussion, (3) both the VR game and facilitated discussion were deemed as integral and complementary components, and (4) feedback for improving the VR game and discussion. Conclusions: Our findings show that the novel use of immersive VR experiences with interactive discussions can raise awareness of DDB consequences and is a promising method to enhance driving safety education. The widespread accessibility of VR technology allows for scalable integration into driver training programs, warranting a larger, prospective, randomized study. %M 39591605 %R 10.2196/60674 %U https://formative.jmir.org/2024/1/e60674 %U https://doi.org/10.2196/60674 %U http://www.ncbi.nlm.nih.gov/pubmed/39591605 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e59572 %T Factors Influencing Poststroke Cognitive Dysfunction: Cross-Sectional Analysis %A Zhou,Wu %A Feng,HaiXia %A Tao,Hua %A Sun,Hui %A Zhang,TianTian %A Wang,QingXia %A Zhang,Li %+ School of Medicine, Southeast University, 87 Dingjiaqiao, Gulou District, Jiangsu Province, Nanjing, 210009, China, 86 02583272077, xrzfhx@163.com %K stroke %K cognitive dysfunction %K analysis of associated factors %K MMSE %K Mini-Mental State Examination %K status survey %K cognitive %K survey %K cognitive impairment %K cross-sectional study %K cross sectional %K stroke patients %K cognition %K education %D 2024 %7 19.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Poststroke cognitive impairment (PSCI) is a common and debilitating complication that affects stroke survivors, impacting memory, attention, and executive function. Despite its prevalence, the factors contributing to PSCI remain unclear, with limited insights into how demographic and clinical variables influence cognitive outcomes. Objective: This study investigates the incidence of cognitive impairment in patients with stroke and examines key demographic and clinical factors, such as age, gender, and education level, which contribute to cognitive decline. The aim is to provide a deeper understanding of PSCI to inform early intervention strategies for improving patient outcomes. Methods: A cross-sectional study was conducted on 305 patients with ischemic stroke admitted to Zhongda Hospital, Southeast University, from January 2019 to September 2022. Cognitive function was assessed using the Mini-Mental State Examination (MMSE) within 72 hours of hospital admission. Demographic information, including age, gender, and education level, were collected. Statistical analyses were performed using chi-square tests, independent t tests, and multivariate regression to assess the relationship between cognitive function and key variables. Pearson correlation analysis explored associations among age, education, and MMSE scores. Results: Among the 305 patients with stroke, 16.7% (n=51) were diagnosed with cognitive impairment based on MMSE scores. The prevalence of cognitive impairment was slightly higher in males (17.6%, n=159) than females (15.8%, n=146), but this difference was not statistically significant. A strong negative correlation was found between MMSE scores and age (r=–0.32; P<.01), indicating that older patients had lower cognitive function. Education level showed a positive correlation with MMSE scores (r=0.41; P<.01), with patients with higher educational attainment demonstrating better cognitive outcomes. Cognitive function showed a marked decline in patients older than 60 years, particularly in domains such as memory, attention, and language skills. Conclusions: This study confirms that age and education are significant factors in determining cognitive outcomes after stroke. The results align with existing literature showing that cognitive function declines with age, while higher educational attainment serves as a protective factor. The findings suggest that individuals with greater cognitive reserve, often linked to higher education, are better equipped to cope with the impact of brain injury. However, the study’s reliance on MMSE may have limited its ability to detect domain-specific impairments. Future studies should consider using more sensitive cognitive tools, such as the Montreal Cognitive Assessment (MoCA), to provide a more comprehensive evaluation of PSCI. Cognitive impairment is prevalent among stroke survivors, with age and education level being key factors influencing outcomes. These findings underscore the importance of early detection and targeted interventions to mitigate cognitive decline. Further research with larger samples and more sensitive cognitive assessments is needed to fully understand PSCI and improve rehabilitation strategies for patients with stroke. %M 39560985 %R 10.2196/59572 %U https://formative.jmir.org/2024/1/e59572 %U https://doi.org/10.2196/59572 %U http://www.ncbi.nlm.nih.gov/pubmed/39560985 %0 Journal Article %@ 2369-3762 %I JMIR Publications %V 10 %N %P e51173 %T A Pilot Project to Promote Research Competency in Medical Students Through Journal Clubs: Mixed Methods Study %A Karabacak,Mert %A Ozcan,Zeynep %A Ozkara,Burak Berksu %A Furkan,Zeynep Sude %A Bisdas,Sotirios %K medical student %K research %K peer education %K student society %K journal club %K skills %K scientific investigation %K undergraduate %K student-led %K initiative %K resources %K research training %K competency %K continuing education %K research improvement %K motivation %K mentor %K mentorship %K medical education %D 2024 %7 31.10.2024 %9 %J JMIR Med Educ %G English %X Background: Undergraduate medical students often lack hands-on research experience and fundamental scientific research skills, limiting their exposure to the practical aspects of scientific investigation. The Cerrahpasa Neuroscience Society introduced a program to address this deficiency and facilitate student-led research. Objective: The primary goal of this initiative was to enhance medical students’ research output by enabling them to generate and publish peer-reviewed papers within the framework of this pilot project. The project aimed to provide an accessible, global model for research training through structured journal clubs, mentorship from experienced peers, and resource access. Methods: In January 2022, a total of 30 volunteer students from various Turkish medical schools participated in this course-based undergraduate research experience program. Students self-organized into 2 groups according to their preferred study type: original research or systematic review. Two final-year students with prior research experience led the project, developing training modules using selected materials. The project was implemented entirely online, with participants completing training modules before using their newly acquired theoretical knowledge to perform assigned tasks. Results: Based on student feedback, the project timeline was adjusted to allow for greater flexibility in meeting deadlines. Despite these adjustments, participants successfully completed their tasks, applying the theoretical knowledge they had gained to their respective assignments. As of April 2024, the initiative has culminated in 3 published papers and 3 more under peer review. The project has also seen an increase in student interest in further involvement and self-paced learning. Conclusions: This initiative leverages globally accessible resources for research training, effectively fostering research competency among participants. It has successfully demonstrated the potential for undergraduates to contribute to medical research output and paved the way for a self-sustaining, student-led research program. Despite some logistical challenges, the project provided valuable insights for future implementations, showcasing the potential for students to engage in meaningful, publishable research. %R 10.2196/51173 %U https://mededu.jmir.org/2024/1/e51173 %U https://doi.org/10.2196/51173 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e60939 %T Ensuring Accuracy and Equity in Vaccination Information From ChatGPT and CDC: Mixed-Methods Cross-Language Evaluation %A Joshi,Saubhagya %A Ha,Eunbin %A Amaya,Andee %A Mendoza,Melissa %A Rivera,Yonaira %A Singh,Vivek K %+ School of Communication & Information, Rutgers University, 4 Huntington Street, New Brunswick, NJ, 08901, United States, 1 848 932 7588, v.singh@rutgers.edu %K vaccination %K health equity %K multilingualism %K language equity %K health literacy %K online health information %K conversational agents %K artificial intelligence %K large language models %K health information %K public health %D 2024 %7 30.10.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: In the digital age, large language models (LLMs) like ChatGPT have emerged as important sources of health care information. Their interactive capabilities offer promise for enhancing health access, particularly for groups facing traditional barriers such as insurance and language constraints. Despite their growing public health use, with millions of medical queries processed weekly, the quality of LLM-provided information remains inconsistent. Previous studies have predominantly assessed ChatGPT’s English responses, overlooking the needs of non–English speakers in the United States. This study addresses this gap by evaluating the quality and linguistic parity of vaccination information from ChatGPT and the Centers for Disease Control and Prevention (CDC), emphasizing health equity. Objective: This study aims to assess the quality and language equity of vaccination information provided by ChatGPT and the CDC in English and Spanish. It highlights the critical need for cross-language evaluation to ensure equitable health information access for all linguistic groups. Methods: We conducted a comparative analysis of ChatGPT’s and CDC’s responses to frequently asked vaccination-related questions in both languages. The evaluation encompassed quantitative and qualitative assessments of accuracy, readability, and understandability. Accuracy was gauged by the perceived level of misinformation; readability, by the Flesch-Kincaid grade level and readability score; and understandability, by items from the National Institutes of Health’s Patient Education Materials Assessment Tool (PEMAT) instrument. Results: The study found that both ChatGPT and CDC provided mostly accurate and understandable (eg, scores over 95 out of 100) responses. However, Flesch-Kincaid grade levels often exceeded the American Medical Association’s recommended levels, particularly in English (eg, average grade level in English for ChatGPT=12.84, Spanish=7.93, recommended=6). CDC responses outperformed ChatGPT in readability across both languages. Notably, some Spanish responses appeared to be direct translations from English, leading to unnatural phrasing. The findings underscore the potential and challenges of using ChatGPT for health care access. Conclusions: ChatGPT holds potential as a health information resource but requires improvements in readability and linguistic equity to be truly effective for diverse populations. Crucially, the default user experience with ChatGPT, typically encountered by those without advanced language and prompting skills, can significantly shape health perceptions. This is vital from a public health standpoint, as the majority of users will interact with LLMs in their most accessible form. Ensuring that default responses are accurate, understandable, and equitable is imperative for fostering informed health decisions across diverse communities. %M 39476380 %R 10.2196/60939 %U https://formative.jmir.org/2024/1/e60939 %U https://doi.org/10.2196/60939 %U http://www.ncbi.nlm.nih.gov/pubmed/39476380 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e56411 %T Tailoring HIV Care for Black Populations: A Pilot Feasibility Prospective Cohort Study %A Young,BreAnne %A Carrasquillo,Olveen %A Jones,Deborah L %A Pan,Yue %A Kenya,Sonjia %+ Department of Medicine, University of Miami Miller School of Medicine, Clinical Research Center, 1120 NW 14th St, Miami, FL, 33136, United States, 1 3052435505, b.young4@umiami.edu %K community health workers %K CHWs %K society %K social determinants of health %K social factor %K social disparity %K social inequality %K social inequity %K HIV disparities %K HIV %K human immunodeficiency virus %K AIDS %K feasibility %K care continuum %K Black %K African American %D 2024 %7 4.10.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Research has shown that integrating community health workers (CHWs) into the formal health care system can improve outcomes for people living with HIV, yet there is limited literature exploring this framework among marginalized minority populations. Objective: Herein, we discuss the feasibility of a clinic-embedded CHW strategy to improve antiretroviral therapy adherence among Black people living with HIV in Miami-Dade County, Florida, a designated priority region for the US Department of Health and Human Services’ Ending the HIV Epidemic Initiative. Methods: From December 2022 to September 2023, three CHWs were trained and integrated into the hospital workflow to provide support as members of the clinical team. Ten Black adults with an HIV viral load over 200 copies/mL were enrolled to received 3 months of CHW support focused on navigating the health system and addressing poor social determinants of health. Intervention feasibility was based on 4 criteria: recruitment rate, demographic composition, study fidelity, and qualitative feedback on CHW perceptions. Results: Participants were recruited at a rate of 5.7 participants per month, with the sample evenly distributed between men and women. Retention was moderately strong, with 7 (70%) of the 10 participants attending more than 75% of CHW sessions. Qualitative feedback reflected CHW perceptions on clinical interactions and intervention length. Conclusions: Outcomes indicate that a clinic-integrated CHW approach is a feasible and acceptable methodology to address adverse social determinants and improve HIV treatment adherence. By offering targeted social and clinical support, CHWs may be a promising solution to achieve sustained viral suppression and care engagement for Black people living with HIV. %M 39365989 %R 10.2196/56411 %U https://formative.jmir.org/2024/1/e56411 %U https://doi.org/10.2196/56411 %U http://www.ncbi.nlm.nih.gov/pubmed/39365989 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e56878 %T Ascertaining Out-of-Pocket Costs of Dementia Care: Feasibility Study of a Web-Based Weekly Survey %A Dawson,Walter D %A Mattek,Nora %A Gothard,Sarah %A Kaye,Jeffrey %A Lindauer,Allison %+ Oregon Alzheimer’s Disease Research Center, School of Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, CR131, Portland, OR, 97239, United States, 1 5034946976, dawsonw@ohsu.edu %K Alzheimer disease %K caregiving %K out-of-pocket costs %K behavioral and psychological symptoms of dementia %K technological interventions %K clinical trials %K dementias %D 2024 %7 25.9.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Caring for a family member living with dementia is costly. A major contributor to care demands, and therefore to the costs, are the behavioral symptoms of dementia. Here, we examine the feasibility of ascertaining costs related to caregiving from weekly web-based surveys collected during a telehealth-based behavioral intervention study—Support via Technology: Living and Learning with Advancing Alzheimer Disease. Objective: This study aims to determine the feasibility and acceptability of using a web-based weekly survey to capture real-time data on out-of-pocket caregiving expenses and time commitments associated with dementia care. To examine relationships between behavioral symptoms, care partner reactivity, burden, and out-of-pocket dementia care costs. Methods: Feasibility was measured by accrual, retention, and data completion by participating care partners. Behavioral symptoms, care partner reactivity, and burden were collected before and after the intervention from 13 care partners. Weekly web-based surveys queried Support via Technology: Living and Learning with Advancing Alzheimer Disease care partners about their out-of-pocket costs associated with care-related activities. The surveys included questions on out-of-pocket costs care partners incurred from hospitalizations and emergency department use, primary care provider visits, use of paid in-home care or respite services, use of prescription medications, and use of over-the-counter medications. The surveys also queried the amount of time care partners devoted to these specific care–related activities. Results: Out-of-pocket costs of dementia care were collected via a web-based weekly survey for up to 18 months. In-home assistance was the most frequently reported type of out-of-pocket care expense and the costliest. care partners who paid for in-home assistance or respite reported more behavioral and psychological symptoms of dementia behaviors, higher reactivity, and higher burden than those who did not. Conclusions: This novel web-based weekly survey–based approach offers lessons for designing and implementing future cost-focused studies and care partner–supportive telehealth-based interventions for Alzheimer disease and related dementias (ADRD). The results correspond with the existing understanding of ADRD in that high family-related out-of-pocket costs are a typical part of the caregiving experience, and those costs likely increase with dementia severity. The results may also offer potential insights to health systems and policy makers as they seek to implement telehealth-based and related interventions that seek to better support people living with ADRD and their family care partners. Trial Registration: ClinicalTrials.gov NCT04335110; https://clinicaltrials.gov/ct2/show/NCT04335110 %M 39321453 %R 10.2196/56878 %U https://formative.jmir.org/2024/1/e56878 %U https://doi.org/10.2196/56878 %U http://www.ncbi.nlm.nih.gov/pubmed/39321453 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e59914 %T Assessment of Clinical Metadata on the Accuracy of Retinal Fundus Image Labels in Diabetic Retinopathy in Uganda: Case-Crossover Study Using the Multimodal Database of Retinal Images in Africa %A Arunga,Simon %A Morley,Katharine Elise %A Kwaga,Teddy %A Morley,Michael Gerard %A Nakayama,Luis Filipe %A Mwavu,Rogers %A Kaggwa,Fred %A Ssempiira,Julius %A Celi,Leo Anthony %A Haberer,Jessica E %A Obua,Celestino %+ Massachusetts General Hospital Center for Global Health, Department of Medicine, Harvard Medical School, 125 Nashua St., Boston, MA, 02114, United States, 1 617 726 2000, kemorley@mgh.harvard.edu %K image labeling %K metadata %K diabetic retinopathy %K assessment %K bias %K multimodal database %K retinal images %K Africa %K African %K artificial intelligence %K AI %K screening algorithms %K screening %K algorithms %K diabetic %K diabetes %K treatment %K sensitivity %K clinical images %D 2024 %7 18.9.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Labeling color fundus photos (CFP) is an important step in the development of artificial intelligence screening algorithms for the detection of diabetic retinopathy (DR). Most studies use the International Classification of Diabetic Retinopathy (ICDR) to assign labels to CFP, plus the presence or absence of macular edema (ME). Images can be grouped as referrable or nonreferrable according to these classifications. There is little guidance in the literature about how to collect and use metadata as a part of the CFP labeling process. Objective: This study aimed to improve the quality of the Multimodal Database of Retinal Images in Africa (MoDRIA) by determining whether the availability of metadata during the image labeling process influences the accuracy, sensitivity, and specificity of image labels. MoDRIA was developed as one of the inaugural research projects of the Mbarara University Data Science Research Hub, part of the Data Science for Health Discovery and Innovation in Africa (DS-I Africa) initiative. Methods: This is a crossover assessment with 2 groups and 2 phases. Each group had 10 randomly assigned labelers who provided an ICDR score and the presence or absence of ME for each of the 50 CFP in a test image with and without metadata including blood pressure, visual acuity, glucose, and medical history. Specificity and sensitivity of referable retinopathy were based on ICDR scores, and ME was calculated using a 2-sided t test. Comparison of sensitivity and specificity for ICDR scores and ME with and without metadata for each participant was calculated using the Wilcoxon signed rank test. Statistical significance was set at P<.05. Results: The sensitivity for identifying referrable DR with metadata was 92.8% (95% CI 87.6-98.0) compared with 93.3% (95% CI 87.6-98.9) without metadata, and the specificity was 84.9% (95% CI 75.1-94.6) with metadata compared with 88.2% (95% CI 79.5-96.8) without metadata. The sensitivity for identifying the presence of ME was 64.3% (95% CI 57.6-71.0) with metadata, compared with 63.1% (95% CI 53.4-73.0) without metadata, and the specificity was 86.5% (95% CI 81.4-91.5) with metadata compared with 87.7% (95% CI 83.9-91.5) without metadata. The sensitivity and specificity of the ICDR score and the presence or absence of ME were calculated for each labeler with and without metadata. No findings were statistically significant. Conclusions: The sensitivity and specificity scores for the detection of referrable DR were slightly better without metadata, but the difference was not statistically significant. We cannot make definitive conclusions about the impact of metadata on the sensitivity and specificity of image labels in our study. Given the importance of metadata in clinical situations, we believe that metadata may benefit labeling quality. A more rigorous study to determine the sensitivity and specificity of CFP labels with and without metadata is recommended. %R 10.2196/59914 %U https://formative.jmir.org/2024/1/e59914 %U https://doi.org/10.2196/59914 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e58802 %T Degenerative Cervical Myelopathy Awareness in Primary Care: UK National Cross-Sectional Survey of General Practitioners %A Rufus-Toye,Remi M %A Rafati Fard,Amir %A Mowforth,Oliver D %A McCarron,Luke V %A Chan,Kayen %A Hirayama,Yuri %A Smith,Emma K %A Veremu,Munashe %A Davies,Benjamin M %A Brannigan,Jamie F M %+ Nuffield Department of Clinical Neurosciences, University of Oxford, John Radcliffe Hospital, Headington, Oxford, OX3 9DU, United Kingdom, 44 7825545404, Jamie.brannigan@medsci.ox.ac.uk %K cervical spine %K degeneration %K general practice %K myelopathy %K neurology %K neurosurgery %K medical education %K cervical myelopathy %K primary care %K misdiagnosis %D 2024 %7 19.8.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Degenerative cervical myelopathy (DCM) is a progressive neurological condition, characterized by spinal cord injury secondary to degenerative changes in the spine. Misdiagnosis in primary care forms part of a complex picture leading to an average diagnostic delay of 2 years. This leads to potentially preventable and permanent disability. A lack of awareness secondary to deficits in postgraduate education may contribute to these delays. Objective: This study aims to assess the awareness of DCM in the setting of general practice. Methods: General practitioners completed a quantitative web-based cross-sectional questionnaire. The 17-item questionnaire captured data regarding demographics, subjective awareness, and objective knowledge. The questionnaire was disseminated via professional networks, including via practice managers and senior practice partners. Incentivization was provided via a bespoke DCM fact sheet for those that completed the survey. Results: A total of 54 general practitioners representing all 4 UK nations responded to the survey. General practitioners most commonly self-assessed that they had “limited awareness” of DCM (n=24, 51%). General practitioners felt most commonly “moderately able” to recognize a case of DCM (n=21, 46%). In total, 13% (n=6) of respondents reported that they would not be at all able to recognize a patient with DCM. Respondents most commonly reported that they were “moderately confident” in their ability to triage a patient with DCM (n=19, 41%). A quarter of respondents reported no prior introduction to DCM throughout their medical training (n=13, 25%). The mean score for knowledge-based questions was 42.6% (SD 3.96%) with the lowest performance observed in patient demographic and clinical recognition items. Conclusions: General practitioners lack confidence in the recognition and management of DCM. These findings are consistent with the diagnostic delays previously described in the literature at the primary care level. Further work to develop and implement educational interventions to general practitioner practices is a crucial step to improving patient outcomes in DCM. %M 39158957 %R 10.2196/58802 %U https://formative.jmir.org/2024/1/e58802 %U https://doi.org/10.2196/58802 %U http://www.ncbi.nlm.nih.gov/pubmed/39158957 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54288 %T Measuring Population-Level Adolescent Mental Health Using a Single-Item Indicator of Experiences of Sadness and Hopelessness: Cross-Sectional Study %A Verlenden,Jorge %A Pampati,Sanjana %A Heim Viox,Melissa %A Brener,Nancy %A Licitis,Laima %A Dittus,Patricia %A Ethier,Kathleen %+ Division of Adolescent and School Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Chamblee Campus, 4770 Buford Highway, Atlanta, GA, 30341, United States, 1 404 498 6018, nlx7@cdc.gov %K adolescents %K mental health %K surveillance %K teens %K sadness %K hopelessness %D 2024 %7 26.7.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Population-level monitoring of adolescent mental health is a critical public health activity used to help define local, state, and federal priorities. The Youth Risk Behavior Surveillance System includes a single-item measure of experiences of sadness or hopelessness as an indicator of risk to mental health. In 2021, 42% of high school students reported having felt sad or hopeless for 2 weeks or more during the past 12 months. The high prevalence of US high school students with this experience has been highlighted in recent studies and media reports. Objective: This study seeks to examine associations between this single-item measure of experiences of sadness or hopelessness with other indicators of poor mental health including frequent mental distress and depressive symptoms. Methods: We analyzed survey data from a national sample of 737 adolescents aged 15-19 years as a part of the Teen and Parent Surveys of Health. Participants were recruited from AmeriSpeak, a probability-based panel designed to be representative of the US household population. Feeling sad or hopeless was operationalized as a “yes” response to the item, “During the past 12 months, did you ever feel so sad or hopeless almost every day for 2 weeks or more in a row that you stopped doing some usual activities?” Unadjusted and adjusted prevalence ratios (aPRs) were calculated to examine associations between the single-item measure of having felt sad or hopeless almost every day for 2 weeks with moderate to severe depressive symptoms, frequent mental distress, and functional limitation due to poor mental health. Adjusted models controlled for age, race and ethnicity, sex assigned at birth, and sexual identity. Results: Overall, 17.3% (unweighted: 138/735) of adolescents reported that they felt sad or hopeless for 2 weeks or more during the past 12 months, 30.2% (unweighted: 204/716) reported moderate to severe depressive symptoms, 18.4% (unweighted: 126/732) reported frequent mental distress, and 15.4% (unweighted: 107/735) reported functional limitation due to poor mental health. After adjusting for demographics, adolescents who reported that they felt sad or hopeless for 2 weeks or more were 3.3 times as likely to report moderate to severe depressive symptoms (aPR 3.28, 95% CI 2.39-4.50), 4.8 times as likely to indicate frequent mental distress (aPR 4.75, 95% CI 2.92-7.74), and 7.8 times as likely to indicate mental health usually or always interfered with their ability to do things (aPR 7.78, 95% CI 4.88-12.41). Conclusions: Associations between having felt sad or hopeless for 2 weeks or more and moderate to severe depressive symptoms, frequent mental distress, and functional limitation due to poor mental health suggest the single-item indicator may represent relevant symptoms associated with poor mental health and be associated with unmet health needs. Findings suggest the single-item indicator provides a population-level snapshot of adolescent experiences of poor mental health. %M 39059010 %R 10.2196/54288 %U https://formative.jmir.org/2024/1/e54288 %U https://doi.org/10.2196/54288 %U http://www.ncbi.nlm.nih.gov/pubmed/39059010 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e39779 %T Design, Develop, and Pilot-Test a Digital Platform to Enhance Student Well-Being: Protocol for a Mixed-Methods Study %A Joshi,Ashish %A Kaur,Kamalpreet %A Bhatt,Ashruti %A Surapaneni,Krishna Mohan %A Grover,Ashoo %A Pandya,Apurva Kumar %+ School of Public Health, University of Memphis, 236 Robison Hall, Memphis, TN, 38152, United States, 1 443 570 6018, ashish1875@gmail.com %K well-being %K students %K digital interventions %K social support %K family demands %K mental well-being %D 2024 %7 23.7.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Well-being is a multidimensional concept and has been extended to many areas. Student well-being has garnered attention over the last decade due to concerns that have been raised. Digital health interventions have the potential to enhance and improve student well-being. Objective: The objective of the study is to design, develop, and pilot-test a digital health platform to enhance student well-being. Methods: A sample size of 5000 participants will be recruited across Gujarat and Tamil Nadu, India. Students will be enrolled from Parul University in Vadodara, Gujarat, as well as Panimalar Medical College Hospital and Research Institute, Panimalar Engineering College, Panimalar Institute of Technology, and Panimalar College of Nursing in Chennai, Tamil Nadu. Current undergraduate and graduate students consenting to participate will be recruited using convenience sampling from these institutes. The study will collect baseline data to construct the student well-being index. Based on the risk profile, a random subset of the population will be provided access to the digital health intervention, which will deliver tailored interactive messages addressing the various dimensions of well-being among undergraduate and graduate students. The eligible study participants will be aged 18 years and older, enrolled in these institutes, and willing to give their consent to participate in the study. Results: The proposed research is an unfunded study. The enrollment of the individuals in the study began in October 2022. Data gathered will be analyzed using SAS (version 9.3; SAS Institute) and results will be reported as 95% CIs and P values. Conclusions: The proposed study will help to determine the factors affecting well-being among college students and help in designing digital health interventions to improve the well-being of undergraduate and graduate students. International Registered Report Identifier (IRRID): PRR1-10.2196/39779 %M 39042879 %R 10.2196/39779 %U https://www.researchprotocols.org/2024/1/e39779 %U https://doi.org/10.2196/39779 %U http://www.ncbi.nlm.nih.gov/pubmed/39042879 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e58322 %T Using the Preparation Phase of the Multiphase Optimization Strategy to Design an Antiextremism Program in Bahrain: Formative and Pilot Research %A Rulison,Kelly %A Weaver,GracieLee %A Milroy,Jeffrey %A Beamon,Emily %A Kelly,Samantha %A Ameeni,Ali %A Juma,Amina %A Abualgasim,Fadhel %A Husain,Jaafar %A Wyrick,David %+ Prevention Strategies, 9 Provence Ct, Greensboro, NC, 27410, United States, 1 3366885770, kelly@preventionstrategies.com %K Antiextremism %K peaceful coexistence %K intervention %K evaluation %K international %K multiphase optimization strategy %K preparation phase %K extremism %K extremist %K peace %K peaceful %K resistance %K violent %K violence %K radical %K radicalism %K Bahrain %K education %K educational %K school %K schools %K student %K students %K drug %K drugs %K abuse %K substance %D 2024 %7 17.7.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Extremism continues to raise concerns about conflict and violent attacks that can lead to deaths, injuries, trauma, and stress. Adolescents are especially vulnerable to radicalization by extremists. Given its location in a region that often experiences extremism, Bahrain developed 4 peaceful coexistence lessons and 4 antiextremism lessons to be implemented as part of their Drug Abuse Resistance Education (D.A.R.E.) program. Objective: The aim of this study is to report the results of the preparation phase of the multiphase optimization strategy (MOST) to develop a peaceful coexistence program and an antiextremism program implemented by D.A.R.E. officers in Bahrain. Methods: We developed conceptual models for the peaceful coexistence and antiextremism programs, indicating which mediators each lesson should target, the proximal outcomes that should be shaped by these mediators, and the distal and ultimate outcomes that the intervention should change. We recruited 20 middle schools to pilot test our research protocol, survey measures, and the existing intervention lessons. A total of 854 seventh and ninth grade students completed a pretest survey, 4 peaceful coexistence intervention lessons, and an immediate posttest survey; and a total of 495 ninth grade students completed the pretest survey, 4 antiextremism lessons, and an immediate posttest survey. A series of 3-level models, nesting students within classrooms within schools, tested mean differences from pretest to posttest. Results: Pilot test results indicated that most measures had adequate reliability and provided promising evidence that the existing lessons could change some of the targeted mediators and proximal outcomes. Specifically, students who completed the peaceful coexistence lessons reported significant changes in 5 targeted mediating variables (eg, injunctive norms about intolerance, P<.001) and 3 proximal outcomes [eg, social skills empathy (P=.008); tolerance beliefs (P=.041)]. Students who completed the antiextremism lessons reported significant changes in 3 targeted mediators [eg, self-efficacy to use resistance skills themselves (P<.001)], and 1 proximal outcome (ie, social skills empathy, P<.001). Conclusions: An effective antiextremism program has the potential to protect youth from radicalization and increase peaceful coexistence. We used the preparation phase of MOST to (1) develop a conceptual model, (2) identify the 4 lessons in each program as the components we will evaluate in the optimization phase of MOST, (3) pilot test the existing lessons, our newly developed measures, and research protocol, and (4) determine that our optimization objective will be all effective components. We will use these results to revise the existing lessons and conduct optimization trials to evaluate the efficacy of the individual lessons. %M 39018090 %R 10.2196/58322 %U https://formative.jmir.org/2024/1/e58322 %U https://doi.org/10.2196/58322 %U http://www.ncbi.nlm.nih.gov/pubmed/39018090 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e59121 %T Characterizing Mental Health Status and Service Utilization in Chinese Americans With Type 2 Diabetes in New York City: Cross-Sectional Study %A Shi,Yun %A Wu,Bei %A Islam,Nadia %A Sevick,Mary Ann %A Shallcross,Amanda J %A Levy,Natalie %A Tamura,Kosuke %A Bao,Han %A Lieu,Ricki %A Xu,Xinyi %A Jiang,Yulin %A Hu,Lu %+ Center for Healthful Behavior Change, New York University Grossman School of Medicine, New York University Langone Health, 180 Madison Ave, 7th floor, New York, NY, 10016, United States, 1 6465013438, lu.hu@nyulangone.org %K mental health %K diabetes distress %K depression %K anxiety %K service utilization %K psychological distress %K type 2 diabetes %K diabetes %K United States %K mental health burden %K Chinese American %K cross-sectional %K telephone survey %K stress %K depressive symptoms %K mental health care %K mental health screening %D 2024 %7 2.7.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Emerging evidence indicates that individuals with type 2 diabetes (T2D) are more prone to mental health issues than the general population; however, there is a significant lack of data concerning the mental health burden in Chinese Americans with T2D. Objective: The aim of this study was to explore the comorbid mental health status, health-seeking behaviors, and mental service utilization among Chinese Americans with T2D. Methods: A cross-sectional telephone survey was performed among 74 Chinese Americans with T2D in New York City. We used standardized questionnaires to assess mental health status and to gather data on mental health–seeking behaviors and service utilization. Descriptive statistics were applied for data analysis. Results: A total of 74 Chinese Americans with T2D completed the survey. Most participants (mean age 56, SD 10 years) identified as female (42/74, 57%), were born outside the United States (73/74, 99%), and had limited English proficiency (71/74, 96%). Despite nearly half of the participants (34/74, 46%) reporting at least one mental health concern (elevated stress, depressive symptoms, and/or anxiety), only 3% (2/74) were currently using mental health services. Common reasons for not seeking care included no perceived need, lack of information about Chinese-speaking providers, cost, and time constraints. The cultural and language competence of the provider was ranked as the top factor related to seeking mental health care. Conclusions: Chinese Americans with T2D experience relatively high comorbid mental health concerns yet have low service utilization. Clinicians may consider team-based care to incorporate mental health screening and identify strategies to provide culturally and linguistically concordant mental health services to engage Chinese Americans with T2D. %M 38954806 %R 10.2196/59121 %U https://formative.jmir.org/2024/1/e59121 %U https://doi.org/10.2196/59121 %U http://www.ncbi.nlm.nih.gov/pubmed/38954806 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e13642 %T Assessment of the Feasibility of Objective Parameters as Primary End Points for Patients Affected by Knee Osteoarthritis: Protocol for a Pilot, Open Noncontrolled Trial (:SMILE:) %A Dogaru,Dumitru Emanuel %A Rosu,Serban %A Barattini,Dionisio Franco %A Guadagna,Simone %A Barattini,Luca %A Andor,Bogdan %+ Department of Orthopaedics - Traumatology, Victor Babeş University of Medicine and Pharmacy, St Piața Eftimie Murgu 2, Timisoara, 300041, Romania, 40 0724345115, de.dogaru@gmail.com %K pilot trial %K feasibility study %K knee osteoarthritis %K hyaluronic acid %K outcome assessment %K osteoarthritis %K ultrasonography %K knee %K pain %D 2024 %7 28.6.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Osteoarthritis (OA) is a disabling condition that affects more than one-third of people older than 65 years. Currently, 80% of these patients report movement limitations, 20% are unable to perform major activities of daily living, and approximately 11% require personal care. In 2014, the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) recommended, as the first step in the pharmacological treatment of knee osteoarthritis, a background therapy with chronic symptomatic slow-acting osteoarthritic drugs such as glucosamine sulfate, chondroitin sulfate, and hyaluronic acid. The latter has been extensively evaluated in clinical trials as intra-articular and oral administration. Recent reviews have shown that studies on oral hyaluronic acid generally measure symptoms using only subjective parameters, such as visual analog scales or quality of life questionnaires. As a result, objective measures are lacking, and data validity is generally impaired. Objective: The main goal of this pilot study with oral hyaluronic acid is to evaluate the feasibility of using objective tools as outcomes to evaluate improvements in knee mobility. We propose ultrasound and range of motion measurements with a goniometer that could objectively correlate changes in joint mobility with pain reduction, as assessed by the visual analog scale. The secondary objective is to collect data to estimate the time and budget for the main double-blind study randomized trial. These data may be quantitative (such as enrollment rate per month, number of screening failures, and new potential outcomes) and qualitative (such as site logistical issues, patient reluctance to enroll, and interpersonal difficulties for investigators). Methods: This open-label pilot and feasibility study is conducted in an orthopedic clinic (Timisoara, Romania). The study includes male and female participants, aged 50-70 years, who have been diagnosed with symptomatic knee OA and have experienced mild joint discomfort for at least 6 months. Eight patients must be enrolled and treated with Syalox 300 Plus (River Pharma) for 8 weeks. It is a dietary supplement containing high-molecular-weight hyaluronic acid, which has already been marketed in several European countries. Assessments are made at the baseline and final visits. Results: Recruitment and treatment of the 8 patients began on February 15, 2018, and was completed on May 25, 2018. Data analysis was planned to be completed by the end of 2018. The study was funded in February 2019. We expect the results to be published in a peer-reviewed clinical journal in the last quarter of 2024. Conclusions: The data from this pilot study will be used to assess the feasibility of a future randomized clinical trial in OA. In particular, the planned outcomes (eg, ultrasound and range of motion), safety, and quantitative and qualitative data must be evaluated to estimate in advance the time and budget required for the future main study. Finally, the pilot study should provide preliminary information on the efficacy of the investigational product. Trial Registration: ClinicalTrials.gov NCT03421054; https://clinicaltrials.gov/study/NCT03421054 International Registered Report Identifier (IRRID): RR1-10.2196/13642 %M 38941599 %R 10.2196/13642 %U https://www.researchprotocols.org/2024/1/e13642 %U https://doi.org/10.2196/13642 %U http://www.ncbi.nlm.nih.gov/pubmed/38941599 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e57519 %T The Feasibility and Acceptability of Sharing Video Recordings of Amyotrophic Lateral Sclerosis Clinical Encounters With Patients and Their Caregivers: Pilot Randomized Clinical Trial %A Bratches,Reed W R %A Cohen,Jeffrey %A Carpenter-Song,Elizabeth %A Mistler,Lisa %A Barr,Paul J %+ School of Nursing, University of Alabama at Birmingham, 1720 University Boulevard, Birmingham, AL, 35222, United States, 1 2059316655, rbratches@gmail.com %K feasibility %K acceptability %K amyotrophic lateral sclerosis %K digital intervention %K ALS %K video recording %D 2024 %7 26.6.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Multidisciplinary clinics (MDCs) provide benefits to patients with amyotrophic lateral sclerosis (ALS) and their caregivers, but MDC visits are information-heavy and can last 4 hours, with patients and caregivers meeting with multiple specialists within each MDC visit. There are questions about the effectiveness of current methods of sharing information from MDCs with patients. Video recordings are a promising new method of sharing information that may allow patients and caregivers to revisit the MDC and remind them of clinical recommendations and conversations. Objective: The objective of this trial is to determine the feasibility and acceptability of sharing information through video recordings of ALS MDC visits with patients and caregivers. Methods: This study was a randomized, controlled pilot trial with 3 months of follow-up from April 2021 to March 2022 in a rural multidisciplinary neurology clinic. We recruited patients with ALS, their caregivers, and their clinicians. Patients and their caregivers were randomized to either receive their normal after-visit summary (treatment as usual) or to receive their normal after-visit summary and a video recording of their MDC visit (video). Each specialist visit had its own recording and was accessible by patients and caregivers using a secure web-based platform called HealthPAL over a 3-month follow-up period. Primary study outcomes were feasibility and acceptability of the video intervention measured by recruitment rate (target: 70%), percentage of participants watching videos (target: 75%), and the Feasibility of Intervention Measure and Acceptability of Intervention Measure (targets: 3/5). We hypothesized that video recording would be feasible and acceptable to patients and their caregivers. Results: Of the 30 patients approached, 24 were recruited, while all caregivers (n=21) and clinicians (n=34) approached were recruited. A total of 144 specialist visits were recorded, approximately 12 specialist visits at a median of one MDC visit per patient. Of the recorded patients, 75% (9/12) viewed videos. High median intervention feasibility (4, SD 0.99) and acceptability (4, SD 1.22) of intervention measures were reported by patients and caregivers in the intervention arm. High median intervention feasibility (5, SD 0.21) and acceptability (4.88, SD 0.4) were reported by clinicians. Of the 24 patients, 50% (n=12) did not complete a 3-month follow-up, primarily due to death (n=10). Conclusions: Video recording is highly feasible and acceptable for patients, caregivers, and clinicians at a rural ALS clinic. Our level of attrition is a useful benchmark for future studies in MDC populations. Despite high rates of patient death, 1-week assessments highlight the value of recordings for both patients and caregivers. Trial Registration: ClinicalTrials.gov NCT04719403; https://clinicaltrials.gov/study/NCT04719403 %M 38924779 %R 10.2196/57519 %U https://formative.jmir.org/2024/1/e57519 %U https://doi.org/10.2196/57519 %U http://www.ncbi.nlm.nih.gov/pubmed/38924779 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e58465 %T Visual Function and Driving Performance Under Different Lighting Conditions in Older Drivers: Preliminary Results From an Observational Study %A Yang,Jingzhen %A Alshaikh,Enas %A Yu,Deyue %A Kerwin,Thomas %A Rundus,Christopher %A Zhang,Fangda %A Wrabel,Cameron G %A Perry,Landon %A Lu,Zhong-Lin %+ Center for Injury Research and Policy at the Abigail Wexner Research Institute, Nationwide Children’s Hospital, 700 Children's Drive, Columbus, OH, 43205, United States, 1 6143555852, Ginger.Yang@nationwidechildrens.org %K nighttime driving %K functional vision %K driving simulation %K older drivers %K visual functions %K photopic %K mesopic %K glare %K driving simulator %D 2024 %7 26.6.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Age-related vision changes significantly contribute to fatal crashes at night among older drivers. However, the effects of lighting conditions on age-related vision changes and associated driving performance remain unclear. Objective: This pilot study examined the associations between visual function and driving performance assessed by a high-fidelity driving simulator among drivers 60 and older across 3 lighting conditions: daytime (photopic), nighttime (mesopic), and nighttime with glare. Methods: Active drivers aged 60 years or older participated in visual function assessments and simulated driving on a high-fidelity driving simulator. Visual acuity (VA), contrast sensitivity function (CSF), and visual field map (VFM) were measured using quantitative VA, quantitative CSF, and quantitative VFM procedures under photopic and mesopic conditions. VA and CSF were also obtained in the presence of glare in the mesopic condition. Two summary metrics, the area under the log CSF (AULCSF) and volume under the surface of VFM (VUSVFM), quantified CSF and VFM. Driving performance measures (average speed, SD of speed [SDspeed], SD of lane position (SDLP), and reaction time) were assessed under daytime, nighttime, and nighttime with glare conditions. Pearson correlations determined the associations between visual function and driving performance across the 3 lighting conditions. Results: Of the 20 drivers included, the average age was 70.3 years; 55% were male. Poor photopic VA was significantly correlated with greater SDspeed (r=0.26; P<.001) and greater SDLP (r=0.31; P<.001). Poor photopic AULCSF was correlated with greater SDLP (r=–0.22; P=.01). Poor mesopic VUSFVM was significantly correlated with slower average speed (r=–0.24; P=.007), larger SDspeed (r=–0.19; P=.04), greater SDLP (r=–0.22; P=.007), and longer reaction times (r=–0.22; P=.04) while driving at night. For functional vision in the mesopic condition with glare, poor VA was significantly correlated with longer reaction times (r=0.21; P=.046) while driving at night with glare; poor AULCSF was significantly correlated with slower speed (r=–0.32; P<.001), greater SDLP (r=–0.26; P=.001) and longer reaction times (r=–0.2; P=.04) while driving at night with glare. No other significant correlations were observed between visual function and driving performance under the same lighting conditions. Conclusions: Visual functions differentially affect driving performance in different lighting conditions among older drivers, with more substantial impacts on driving during nighttime, especially in glare. Additional research with larger sample sizes is needed to confirm these results. %M 38922681 %R 10.2196/58465 %U https://formative.jmir.org/2024/1/e58465 %U https://doi.org/10.2196/58465 %U http://www.ncbi.nlm.nih.gov/pubmed/38922681 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 10 %N %P e54313 %T Assessing Outcomes in HIV Prevention and Treatment Programs With Female Sex Workers and Men Who Have Sex With Men: Expanded Polling Booth Survey Protocol %A Bhattacharjee,Parinita %A McClarty,Leigh M %A Kimani,Joshua %A Isac,Shajy %A Wanjiru Kabuti,Rhoda %A Kinyua,Antony %A Karakaja Okoyana,Jaffred %A Njeri Ndukuyu,Virjinia %A Musyoki,Helgar %A Kiplagat,Anthony %A Arimi,Peter %A Shaw,Souradet %A Emmanuel,Faran %A Gandhi,Monica %A Becker,Marissa %A Blanchard,James %+ Institute for Global Public Health, University of Manitoba, R065 Medical Rehabilitation Building, 771 McDermot Ave, Winnipeg, MB, R3E 0T6, Canada, 1 2047893245, leigh.mcclarty@umanitoba.ca %K female sex workers %K men who have sex with men %K Kenya %K polling booth survey %K program science %K HIV prevention %K outcome assessment %D 2024 %7 19.6.2024 %9 Protocol %J JMIR Public Health Surveill %G English %X Background: Assessing HIV outcomes in key population prevention programs is a crucial component of the program cycle, as it facilitates improved planning and monitoring of anticipated results. The Joint United Nations Programme on HIV and AIDS recommends using simple, rapid methods to routinely measure granular and differentiated program outcomes for key populations. Following a program science approach, Partners for Health and Development in Africa, in partnership with the Nairobi County Government and the University of Manitoba, aims to conduct an outcome assessment using a novel, expanded polling booth survey (ePBS) method with female sex workers and men who have sex with men in Nairobi County, Kenya. Objective: This study aims to (1) estimate the incidence and prevalence of HIV; (2) assess biomedical, behavioral, and structural outcomes; and (3) understand barriers contributing to gaps in access and use of available prevention and treatment services among female sex workers and men who have sex with men in Nairobi. Methods: The novel ePBS approach employs complementary data collection methods, expanding upon the traditional polling booth survey (PBS) method by incorporating additional quantitative, qualitative, and biological data collection components and an improved sampling methodology. Quantitative methods will include (1) PBS, a group interview method in which individuals provide responses through a ballot box in an unlinked and anonymous way, and (2) a behavioral and biological survey (BBS), including a face-to-face individual interview and collection of linked biological samples. Qualitative methods will include focus group discussions. The ePBS study uses a 2-stage, population- and location-based random sampling approach involving the random selection of locations from which random participants are selected at a predetermined time on a randomly selected day. PBS data will be analyzed at the group level, and BBS data will be analyzed at an individual level. Qualitative data will be analyzed thematically. Results: Data were collected from April to May 2023. The study has enrolled 759 female sex workers (response rate: 759/769, 98.6%) and 398 men who have sex with men (response rate: 398/420, 94.7%). Data cleaning and analyses are ongoing, with a focus on assessing gaps in program coverage and inequities in program outcomes. Conclusions: The study will generate valuable HIV outcome data to inform program improvement and policy development for Nairobi County’s key population HIV prevention program. This study served as a pilot for the novel ePBS method, which combines PBS, BBS, and focus group discussions to enhance its programmatic utility. The ePBS method holds the potential to fill an acknowledged gap for a rapid, low-cost, and simple method to routinely measure HIV outcomes within programs and inform incremental program improvements through embedded learning processes. %M 38896842 %R 10.2196/54313 %U https://publichealth.jmir.org/2024/1/e54313 %U https://doi.org/10.2196/54313 %U http://www.ncbi.nlm.nih.gov/pubmed/38896842 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e48076 %T Association Between Discrimination and Depressive Symptoms Among Hispanic or Latino Adults During the COVID-19 Pandemic: Cross-Sectional Study %A Ormiston,Cameron K %A Villalobos,Kevin %A Montiel Ishino,Francisco Alejandro %A Williams,Faustine %+ National Institute on Minority Health and Health Disparities, National Institutes of Health, 11545 Rockville Pike, Rockville, MD, 20852, United States, 1 301 827 2727, cameron.ormiston@icahn.mssm.edu %K depressive symptoms %K everyday discrimination %K COVID-19 pandemic %K Hispanic and Latino %K immigrant health %D 2024 %7 6.6.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Discrimination and xenophobia toward Hispanic and Latino communities increased during the COVID-19 pandemic, likely inflicting significant harm on the mental health of Hispanic and Latino individuals. Pandemic-related financial and social instability has disproportionately affected Hispanic and Latino communities, potentially compounding existing disparities and worsening mental health. Objective: This study aims to examine the association between discrimination and depressive symptoms during the COVID-19 pandemic among a national sample of Hispanic and Latino adults. Methods: Data from a 116-item web-based nationally distributed survey from May 2021 to January 2022 were analyzed. The sample (N=1181) was restricted to Hispanic or Latino (Mexican or Mexican American, Puerto Rican; Cuban or Cuban American, Central or South American, and Dominican or another Hispanic or Latino ethnicity) adults. Depression symptoms were assessed using the 2-item Patient Health Questionnaire. Discrimination was assessed using the 5-item Everyday Discrimination Scale. A multinomial logistic regression with a block entry model was used to assess the relationship between discrimination and the likelihood of depressive symptoms, as well as examine how controls and covariates affected the relationship of interest. Results: Mexican or Mexican American adults comprised the largest proportion of the sample (533/1181, 45.13%), followed by Central or South American (204/1181, 17.3%), Puerto Rican (189/1181, 16%), Dominican or another Hispanic or Latino ethnicity (172/1181, 14.6%), and Cuban or Cuban American (83/1181, 7.03%). Approximately 31.26% (367/1181) of the sample had depressive symptoms. Regarding discrimination, 54.56% (634/1181) reported experiencing some form of discrimination. Compared with those who did not experience discrimination, those who experienced discrimination had almost 230% higher odds of depressive symptoms (adjusted odds ratio [AOR] 3.31, 95% CI 2.42-4.54). Also, we observed that sociodemographic factors such as age and gender were significant. Compared with participants aged 56 years and older, participants aged 18-35 years and those aged 36-55 years had increased odds of having depressive symptoms (AOR 3.83, 95% CI 2.13-6.90 and AOR 3.10, 95% CI 1.74-5.51, respectively). Women had higher odds of having depressive symptoms (AOR 1.67, 95% CI 1.23-2.30) than men. Respondents with an annual income of less than US $25,000 (AOR 2.14, 95% CI 1.34-3.41) and US $25,000 to less than US $35,000 (AOR 1.89, 95% CI 1.17-3.06) had higher odds of depressive symptoms than those with an annual income of US $50,000 to less than US $75,000. Conclusions: Our findings provide significant importance especially when considering the compounding, numerous socioeconomic challenges stemming from the pandemic that disproportionately impact the Hispanic and Latino communities. These challenges include rising xenophobia and tensions against immigrants, inadequate access to mental health resources for Hispanic and Latino individuals, and existing hesitations toward seeking mental health services among this population. Ultimately, these findings can serve as a foundation for promoting health equity. %M 38843512 %R 10.2196/48076 %U https://formative.jmir.org/2024/1/e48076 %U https://doi.org/10.2196/48076 %U http://www.ncbi.nlm.nih.gov/pubmed/38843512 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56067 %T Effects of Empagliflozin in Type 2 Diabetes With and Without Chronic Kidney Disease and Nondiabetic Chronic Kidney Disease: Protocol for 3 Crossover Randomized Controlled Trials (SiRENA Project) %A Nielsen,Steffen Flindt %A Duus,Camilla Lundgreen %A Buus,Niels Henrik %A Bech,Jesper Nørgaard %A Mose,Frank Holden %+ University Clinic in Nephrology and Hypertension, Gødstrup Hospital and Aarhus University, Hospitalsparken 15, Herning, 7400, Denmark, 45 21278747, stfnel@rm.dk %K SGLT2i %K empagliflozin %K renal function %K blood flow %K DM2 %K diabetes mellitus type 2 %K CKD %K chronic kidney disease %K vascular function %K sodium-glucose cotransporter 2 inhibitors %K T2DM %K type 2 diabetes mellitus %K randomized controlled trial %K RCT %K CVD %K placebo %K renal %K recruitment %K Denmark %K cardiovascular disease %D 2024 %7 29.5.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sodium-glucose-cotransporter 2 inhibitors (SGLT2is) have revolutionized the treatment of type 2 diabetes mellitus (DM2) and chronic kidney disease (CKD), reducing the risk of cardiovascular and renal end points by up to 40%. The underlying mechanisms are not fully understood. Objective: The study aims to examine the effects of empagliflozin versus placebo on renal hemodynamics, sodium balance, vascular function, and markers of the innate immune system in patients with DM2, DM2 and CKD, and nondiabetic CKD. Methods: We conducted 3 double-blind, crossover, randomized controlled trials, each with identical study protocols but different study populations. We included patients with DM2 and preserved kidney function (estimated glomerular filtration rate >60 mL/min/1.73 m2), DM2 and CKD, and nondiabetic CKD (both with estimated glomerular filtration rate 20-60 mL/min/1.73 m2). Each participant was randomly assigned to 4 weeks of treatment with either 10 mg of empagliflozin once daily or a matching placebo. After a wash-out period of at least 2 weeks, participants were crossed over to the opposite treatment. End points were measured at the end of each treatment period. The primary end point was renal blood flow measured with 82Rubidium positron emission tomography–computed tomography (82Rb-PET/CT). Secondary end points include glomerular filtration rate measured with 99mTechnetium-diethylene-triamine-pentaacetate (99mTc-DTPA) clearance, vascular function assessed by forearm venous occlusion strain gauge plethysmography, measurements of the nitric oxide (NO) system, water and sodium excretion, body composition measurements, and markers of the complement immune system. Results: Recruitment began in April 2021 and was completed in September 2022. Examinations were completed by December 2022. In total, 49 participants completed the project: 16 participants in the DM2 and preserved kidney function study, 17 participants in the DM2 and CKD study, and 16 participants in the nondiabetic CKD study. Data analysis is ongoing. Results are yet to be published. Conclusions: This paper describes the rationale, design, and methods used in a project consisting of 3 double-blind, crossover, randomized controlled trials examining the effects of empagliflozin versus placebo in patients with DM2 with and without CKD and patients with nondiabetic CKD, respectively. Trial Registration: EU Clinical Trials Register 2019-004303-12; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004303-12, EU Clinical Trials Register 2019-004447-80; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004447-80, EU Clinical Trials Register 2019-004467-50; https://www.clinicaltrialsregister.eu/ctr-search/search?query=and+2019-004467-50 International Registered Report Identifier (IRRID): DERR1-10.2196/56067 %M 38680116 %R 10.2196/56067 %U https://www.researchprotocols.org/2024/1/e56067 %U https://doi.org/10.2196/56067 %U http://www.ncbi.nlm.nih.gov/pubmed/38680116 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54605 %T Investigating the Efficacy of a Community Support Network Rehabilitation Intervention for Improving Resiliency, Quality of Life, and Neurocognitive Function in Survivors of Intimate Partner Violence–Caused Brain Injury: Protocol for a Feasibility Study %A Adhikari,Shambhu Prasad %A Stranges,Tori N %A Tehrani,Setareh Nouri Zadeh %A Porter,Shaun %A Mason,Karen %A van Donkelaar,Paul %+ School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada, 1 250 863 3230, paul.vandonkelaar@ubc.ca %K brain injury %K cognitive functions %K community support network %K intimate partner violence %K quality of life %K rehabilitation %D 2024 %7 24.5.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Globally, approximately 1 in 3 women experience intimate partner violence (IPV) in their lifetime. Brain injury (BI) is a common, yet often unrecognized, consequence of IPV. BIs caused by IPV tend to be mild, occur repetitively over the course of months or years, are remote in time, and result in chronic symptoms. Similar to BI from other causes, therapeutic treatment for women with IPV-caused BI (IPV-BI) is crucial to help resolve any physical or cognitive impairments, enhance the quality of life (QoL), and minimize longer-term neurodegeneration. Objective: This study aims to investigate the feasibility and efficacy of a community support network (CSN) rehabilitation intervention regarding its impact on resiliency, QoL, and neurocognitive function. Methods: In this pre- and postexperimental design, women (aged 18 to 50 years) who are survivors of IPV and IPV-BI will be recruited from various community organizations serving survivors of IPV. Exclusion criteria will include current pregnancy and any diagnosed neurological disorder known to affect cerebrovascular, neurocognitive, or sensorimotor function. A CSN rehabilitation intervention that includes aerobic exercise, cognitive training, mindfulness meditation, and counseling will be administered. A trauma-informed approach will be integrated into the design and implementation of the program. Furthermore, the program will include a participant navigator who will provide trauma- and violence-informed advocacy and systems navigation support to participants, in addition to facilitating a monthly peer support group. The intervention will be provided for 2.5 hours a day and 2 days a week for 3 months. Participants will complete psychological assessments and provide clinic-demographic information in the first assessment. In the second (before intervention), third (after intervention), and fourth (at follow-up) sessions, they will complete tests of resiliency, QoL, and neurocognition. The estimated sample size is 100. The objective of this study will be accomplished by quantitatively measuring resiliency, QoL, and neurocognition before and immediately after the intervention. A follow-up assessment will occur 3 months after the completion of the intervention to evaluate the maintenance of any improvements in function. One-way ANOVAs will be used to evaluate the intervention outcome across the testing times. Relationships among various variables will be explored using regression analysis. Results: We anticipate that the CSN rehabilitation intervention will be effective in improving resiliency, QoL, and neurocognitive function in women who have experienced IPV-BI. Furthermore, we anticipate that this intervention will be feasible in terms of study recruitment, adherence, and retention. Conclusions: The CSN rehabilitation intervention will have a positive impact on resiliency, QoL, and neurocognitive functions in survivors of IPV-BI. Subsequently, a comparative study will be conducted by recruiting a control group receiving usual care. International Registered Report Identifier (IRRID): PRR1-10.2196/54605 %M 38788207 %R 10.2196/54605 %U https://www.researchprotocols.org/2024/1/e54605 %U https://doi.org/10.2196/54605 %U http://www.ncbi.nlm.nih.gov/pubmed/38788207 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54043 %T Grocery Delivery to Support Individuals With Type 2 Diabetes: Protocol for a Pilot Quality Improvement Program %A Oshman,Lauren %A Waselewski,Marika %A Hisamatsu,Rina %A Kim,Noa %A Young,Larrea %A Hafez Griauzde,Dina %A Chang,Tammy %+ Department of Family Medicine, University of Michigan, 2800 Plymouth Road, Building 14, Room G128, Ann Arbor, MI, 48109, United States, 1 7347304636, tachang@med.umich.edu %K T2D %K type 2 diabetes %K food insecurity %K low carbohydrate %K quality improvement %K healthy eating %K grocery %K delivery program %K diabetes %K T2DM %K type 2 diabetes mellitus %K low-income %K US %K United States %K adults %K adult %K low diet quality %K carbohydrate %K carbohydrates %K glycemic control %K nutrition education %D 2024 %7 15.5.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: People with low income are disproportionately affected by type 2 diabetes (T2D), and 17.6% of US adults with T2D experience food insecurity and low diet quality. Low-carbohydrate eating plans can improve glycemic control, promote weight loss, and are associated with improved cardiometabolic health and all-cause mortality. Little is known about supporting low-carbohydrate eating for people with T2D, although food-as-medicine interventions paired with nutrition education offer a promising solution. Objective: This program aims to support the initiation of dietary changes by using grocery delivery and low-carbohydrate education to increase the quality of low-carbohydrate nutrition among people with T2D and food insecurity. Methods: This program was a nonrandomized pilot conducted at 21 primary care practices in Michigan. Adults with T2D and food insecurity or low income were eligible to enroll. Patients were referred by primary care clinic staff. All participants received the 3-month program, which included monthly US $80 credits for healthy foods, free grocery delivery from Shipt, and low-carbohydrate nutrition education. Food credits were restricted to the purchase of healthy foods. Education materials, developed in collaboration with providers and patients, included print, digital, interactive web, and video formats. At enrollment, participants completed a survey including demographics, diabetes health, diet and physical activity, and diabetes management and knowledge. After the 3-month program, participants completed a survey with repeat assessments of diabetes health, diet and physical activity, and diabetes management and knowledge. Perspectives on participant experience and perceived program impact, food purchasing behaviors, and use of educational materials were also collected. Diabetes health information was supplemented with data from participant medical records. We plan to perform mixed methods analysis to assess program feasibility, acceptability, and impact. Primary quality improvement (QI) measures are the number of patients referred and enrolled, use of US $80 food credits, analysis of food purchasing behavior, participant experience with the program, and program costs. Secondary QI measures include changes in hemoglobin A1c, weight, medications, self-efficacy, diabetes and carbohydrate knowledge, and activity between baseline and follow-up. Results: This program started in October 2022. Data collection is expected to be concluded in June 2024. A total of 151 patients were referred to the program, and 83 (55%) were enrolled. The average age was 57 (SD 13; range 18-86) years, 72% (57/79) were female, 90% (70/78) were White, and 96% (74/77) were of non-Hispanic ethnicity. All participants successfully ordered grocery delivery during the program. Conclusions: This pilot QI program aimed to improve diet quality among people with T2D and food insecurity by using grocery delivery and low-carbohydrate nutrition education. Our findings may help inform the implementation of future QI programs and research studies on food-as-medicine interventions that include grocery delivery and education for people with T2D. International Registered Report Identifier (IRRID): DERR1-10.2196/54043 %M 38748461 %R 10.2196/54043 %U https://www.researchprotocols.org/2024/1/e54043 %U https://doi.org/10.2196/54043 %U http://www.ncbi.nlm.nih.gov/pubmed/38748461 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54343 %T Impact of Incentives on Physician Participation in Research Surveys: Randomized Experiment %A Hawa,Saadiya %A Bane,Shalmali %A Kinsler,Kayla %A Rector,Amadeia %A Chaichian,Yashaar %A Falasinnu,Titilola %A Simard,Julia F %+ Department of Epidemiology and Population Health, Stanford School of Medicine, Alway Building, 300 Pasteur Drive, M121L, MC: 5405, Stanford, CA, 94305, United States, 1 650 7239680, jsimard@stanford.edu %K internet survey %K incentive %K physician recruitment %K internet surveys %K online survey %K online surveys %K web-based survey %K web-based surveys %K survey %K surveys %K incentives %K monetary incentive %K monetary incentives %K physician participation %K physician participant %K physician participants %K physician %K physicians %K doctor participation %K doctor participant %K doctor participants %K doctor %K doctors %K neurologist %K neurologists %D 2024 %7 14.5.2024 %9 Short Paper %J JMIR Form Res %G English %X Background: Web-based surveys can be effective data collection instruments; however, participation is notoriously low, particularly among professionals such as physicians. Few studies have explored the impact of varying amounts of monetary incentives on survey completion. Objective: This study aims to conduct a randomized study to assess how different incentive amounts influenced survey participation among neurologists in the United States. Methods: We distributed a web-based survey using standardized email text to 21,753 individuals randomly divided into 5 equal groups (≈4351 per group). In phase 1, each group was assigned to receive either nothing or a gift card for US $10, $20, $50, or $75, which was noted in the email subject and text. After 4 reminders, phase 2 began and each remaining individual was offered a US $75 gift card to complete the survey. We calculated and compared the proportions who completed the survey by phase 1 arm, both before and after the incentive change, using a chi-square test. As a secondary outcome, we also looked at survey participation as opposed to completion. Results: For the 20,820 emails delivered, 879 (4.2%) recipients completed the survey; of the 879 recipients, 622 (70.8%) were neurologists. Among the neurologists, most were male (412/622, 66.2%), White (430/622, 69.1%), non-Hispanic (592/622, 95.2%), graduates of American medical schools (465/622, 74.8%), and board certified (598/622, 96.1%). A total of 39.7% (247/622) completed their neurology residency more than 20 years ago, and 62.4% (388/622) practiced in an urban setting. For phase 1, the proportions of respondents completing the survey increased as the incentive amount increased (46/4185, 1.1%; 76/4165, 1.8%; 86/4160, 2.1%; 104/4162, 2.5%; and 119/4148, 2.9%, for US $0, $10, $20, $50, and $75, respectively; P<.001). In phase 2, the survey completion rate for the former US $0 arm increased to 3% (116/3928). Those originally offered US $10, $20, $50, and $75 who had not yet participated were less likely to participate compared with the former US $0 arm (116/3928, 3%; 90/3936, 2.3%; 80/3902, 2.1%; 88/3845, 2.3%; and 74/3878, 1.9%, for US $0, $10, $20, $50, and $75, respectively; P=.03). For our secondary outcome of survey participation, a trend similar to that of survey completion was observed in phase 1 (55/4185, 1.3%; 85/4165, 2%; 96/4160, 2.3%; 118/4162, 2.8%; and 135/4148, 3.3%, for US $0, $10, $20, $50, and $75, respectively; P<.001) and phase 2 (116/3928, 3%; 90/3936, 2.3%; 80/3902, 2.1%; 88/3845, 2.3%; and 86/3845, 2.2%, for US $0, $10, $20, $50, and $75, respectively; P=.10). Conclusions: As expected, monetary incentives can boost physician survey participation and completion, with a positive correlation between the amount offered and participation. %M 38743466 %R 10.2196/54343 %U https://formative.jmir.org/2024/1/e54343 %U https://doi.org/10.2196/54343 %U http://www.ncbi.nlm.nih.gov/pubmed/38743466 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e51728 %T Quality Improvement Intervention Using Social Prescribing at Discharge in a University Hospital in France: Quasi-Experimental Study %A Cailhol,Johann %A Bihan,Hélène %A Bourovali-Zade,Chloé %A Boloko,Annie %A Duclos,Catherine %+ Laboratoire Educations et Promotion de la Santé, University Sorbonne Paris Nord, 74 rue marcel cachin, Bobigny, 93007, France, 33 148955426, johann.cailhol@aphp.fr %K social prescription %K discharge coordination %K language barriers %K readmission rates %K ethnic matching %K trust %K personalized care %K discharge %K social determinant %K social need %K tool %K quality of care %K readmission %K quality improvement %D 2024 %7 13.5.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Social prescription is seen as a public health intervention tool with the potential to mitigate social determinants of health. On one side, social prescription is not yet well developed in France, where social workers usually attend to social needs, and historically, there is a deep divide between the health and social sectors. On the other side, discharge coordination is gaining attention in France as a critical tool to improve the quality of care, assessed indirectly using unplanned rehospitalization rates. Objective: This study aims to combine social prescription and discharge coordination to assess the need for social prescription and its effect on unplanned rehospitalization rates. Methods: We conducted a quasi-experimental study in two departments of medicine in a French university hospital in a disadvantaged suburb of Paris over 2 years (October 2019-October 2021). A discharge coordinator screened patients for social prescribing needs and provided services on the spot or referred the patient to the appropriate service when needed. The primary outcome was the description of the services delivered by the discharge coordinator and of its process, as well as the characteristics of the patients in terms of social needs. The secondary outcome was the comparison of unplanned rehospitalization rates after data chaining. Results: A total of 223 patients were included in the intervention arm, with recruitment being disrupted by the COVID-19 pandemic. More than two-thirds of patients (n=154, 69.1%) needed help understanding discharge information. Slightly less than half of the patients (n=98, 43.9%) seen by the discharge coordinator needed social prescribing, encompassing language, housing, health literacy, and financial issues. The social prescribing covered a large range of services, categorized into finding a general practitioner or private sector nurse, including language-matching; referral to a social worker; referral to nongovernmental organization or group activities; support for transportation issues; support for health-related administrative procedures; and support for additional appointments with nonmedical clinicians. All supports were delivered in a highly personalized way. Ethnic data collection was not legally permitted, but for 81% (n=182) of the patients, French was not the mother tongue. After data chaining, rehospitalization rates were compared between 203 patients who received the intervention (n=5, 3.1%) versus 2095 patients who did not (n=51, 2.6%), and there was no statistical difference. Conclusions: First, our study revealed the breadth of patient’s unmet social needs in our university hospital, which caters to an area where the immigrant population is high. The study also revealed the complexity of the discharge coordinator’s work, who provided highly personalized support and managed to gain trust. Hospital discharge could be used in France as an opportunity in disadvantaged settings. Eventually, indicators other than the rehospitalization rate should be devised to evaluate the effect of social prescribing and discharge coordination. %M 38739912 %R 10.2196/51728 %U https://formative.jmir.org/2024/1/e51728 %U https://doi.org/10.2196/51728 %U http://www.ncbi.nlm.nih.gov/pubmed/38739912 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e53815 %T Cognitive Behavioral Therapy for Symptom Preoccupation Among Patients With Premature Ventricular Contractions: Nonrandomized Pretest-Posttest Study %A Liliequist,Björn E %A Särnholm,Josefin %A Skúladóttir,Helga %A Ólafsdóttir,Eva %A Ljótsson,Brjánn %A Braunschweig,Frieder %+ Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Nobels väg 9, Stockholm, 171 65, Sweden, 46 08 524 800 00, bjorn.liliequist@ki.se %K premature ventricular contractions %K quality of life %K symptom preoccupation %K cognitive behavioral therapy: CBT %D 2024 %7 7.5.2024 %9 Original Paper %J JMIR Cardio %G English %X Background: Premature ventricular contractions (PVCs) are a common cardiac condition often associated with disabling symptoms and impaired quality of life (QoL). Current treatment strategies have limited effectiveness in reducing symptoms and restoring QoL for patients with PVCs. Symptom preoccupation, involving cardiac-related fear, hypervigilance, and avoidance behavior, is associated with disability in other cardiac conditions and can be effectively targeted by cognitive behavioral therapy (CBT). Objective: The aim of this study was to evaluate the effect of a PVC-specific CBT protocol targeting symptom preoccupation in patients with symptomatic idiopathic PVCs. Methods: Nineteen patients diagnosed with symptomatic idiopathic PVCs and symptom preoccupation underwent PVC-specific CBT over 10 weeks. The treatment was delivered by a licensed psychologist via videoconference in conjunction with online text-based information and homework assignments. The main components of the treatment were exposure to cardiac-related symptoms and reducing cardiac-related avoidance and control behavior. Self-rated measures were collected at baseline, post treatment, and at 3- and 6-month follow-ups. The primary outcome was PVC-specific QoL at posttreatment assessment measured with a PVC-adapted version of the Atrial Fibrillation Effects on Quality of Life questionnaire. Secondary measures included symptom preoccupation measured with the Cardiac Anxiety Questionnaire. PVC burden was evaluated with 5-day continuous electrocardiogram recordings at baseline, post treatment, and 6-month follow-up. Results: We observed large improvements in PVC-specific QoL (Cohen d=1.62, P<.001) and symptom preoccupation (Cohen d=1.73, P<.001) post treatment. These results were sustained at the 3- and 6-month follow-ups. PVC burden, as measured with 5-day continuous electrocardiogram, remained unchanged throughout follow-up. However, self-reported PVC symptoms were significantly lower at posttreatment assessment and at both the 3- and 6-month follow-ups. Reduction in symptom preoccupation had a statistically significant mediating effect of the intervention on PVC-specific QoL in an explorative mediation analysis. Conclusions: This uncontrolled pilot study shows preliminary promising results for PVC-specific CBT as a potentially effective treatment approach for patients with symptomatic idiopathic PVCs and symptom preoccupation. The substantial improvements in PVC-specific QoL and symptom preoccupation, along with the decreased self-reported PVC-related symptoms warrant further investigation in a larger randomized controlled trial. Trial Registration: ClinicalTrials.gov NCT05087238; https://clinicaltrials.gov/study/NCT05087238 %M 38713500 %R 10.2196/53815 %U https://cardio.jmir.org/2024/1/e53815 %U https://doi.org/10.2196/53815 %U http://www.ncbi.nlm.nih.gov/pubmed/38713500 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e52344 %T Machine Learning–Based Prediction of Changes in the Clinical Condition of Patients With Complex Chronic Diseases: 2-Phase Pilot Prospective Single-Center Observational Study %A Alvarez-Romero,Celia %A Polo-Molina,Alejandro %A Sánchez-Úbeda,Eugenio Francisco %A Jimenez-De-Juan,Carlos %A Cuadri-Benitez,Maria Pastora %A Rivas-Gonzalez,Jose Antonio %A Portela,Jose %A Palacios,Rafael %A Rodriguez-Morcillo,Carlos %A Muñoz,Antonio %A Parra-Calderon,Carlos Luis %A Nieto-Martin,Maria Dolores %A Ollero-Baturone,Manuel %A Hernández-Quiles,Carlos %+ Internal Medicine Department, Virgen del Rocio University Hospital, Av Manuel Siurot s/n, Sevilla, 41013, Spain, 34 697950012, quiles_es@yahoo.es %K patients with complex chronic diseases %K functional impairment %K Barthel Index %K artificial intelligence %K machine learning %K prediction model %K pilot study %K chronic patients %K chronic %K development study %K prognostic %K diagnostic %K therapeutic %K wearable %K wearables %K wearable activity tracker %K mobility device %K device %K physical activity %K caregiver %D 2024 %7 19.4.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Functional impairment is one of the most decisive prognostic factors in patients with complex chronic diseases. A more significant functional impairment indicates that the disease is progressing, which requires implementing diagnostic and therapeutic actions that stop the exacerbation of the disease. Objective: This study aimed to predict alterations in the clinical condition of patients with complex chronic diseases by predicting the Barthel Index (BI), to assess their clinical and functional status using an artificial intelligence model and data collected through an internet of things mobility device. Methods: A 2-phase pilot prospective single-center observational study was designed. During both phases, patients were recruited, and a wearable activity tracker was allocated to gather physical activity data. Patients were categorized into class A (BI≤20; total dependence), class B (2060; moderate or mild dependence, or independent). Data preprocessing and machine learning techniques were used to analyze mobility data. A decision tree was used to achieve a robust and interpretable model. To assess the quality of the predictions, several metrics including the mean absolute error, median absolute error, and root mean squared error were considered. Statistical analysis was performed using SPSS and Python for the machine learning modeling. Results: Overall, 90 patients with complex chronic diseases were included: 50 during phase 1 (class A: n=10; class B: n=20; and class C: n=20) and 40 during phase 2 (class B: n=20 and class C: n=20). Most patients (n=85, 94%) had a caregiver. The mean value of the BI was 58.31 (SD 24.5). Concerning mobility aids, 60% (n=52) of patients required no aids, whereas the others required walkers (n=18, 20%), wheelchairs (n=15, 17%), canes (n=4, 7%), and crutches (n=1, 1%). Regarding clinical complexity, 85% (n=76) met patient with polypathology criteria with a mean of 2.7 (SD 1.25) categories, 69% (n=61) met the frailty criteria, and 21% (n=19) met the patients with complex chronic diseases criteria. The most characteristic symptoms were dyspnea (n=73, 82%), chronic pain (n=63, 70%), asthenia (n=62, 68%), and anxiety (n=41, 46%). Polypharmacy was presented in 87% (n=78) of patients. The most important variables for predicting the BI were identified as the maximum step count during evening and morning periods and the absence of a mobility device. The model exhibited consistency in the median prediction error with a median absolute error close to 5 in the training, validation, and production-like test sets. The model accuracy for identifying the BI class was 91%, 88%, and 90% in the training, validation, and test sets, respectively. Conclusions: Using commercially available mobility recording devices makes it possible to identify different mobility patterns and relate them to functional capacity in patients with polypathology according to the BI without using clinical parameters. %M 38640473 %R 10.2196/52344 %U https://formative.jmir.org/2024/1/e52344 %U https://doi.org/10.2196/52344 %U http://www.ncbi.nlm.nih.gov/pubmed/38640473 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54077 %T Implementation Documentation and Process Assessment of the PharmNet Intervention: Observational Report %A Eldridge,Lori Ann %A Meyerson,Beth E %A Agley,Jon %+ Prevention Insights, Department of Applied Health Science, School of Public Health Bloomington, Indiana University Bloomington, 809 E 9th Street, Bloomington, IN, 47405, United States, 1 812 855 3123, jagley@indiana.edu %K naloxone %K Narcan %K pharmacy %K harm reduction %K PharmNet %K overdose %K opioids %K implementation %K pragmatic trial %D 2024 %7 18.3.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: The number of overdose deaths in the United States involving opioids continues to exceed 100,000 per year. This has precipitated ongoing declarations of a public health emergency. Harm reduction approaches, such as promoting awareness of, ensuring access to, and fostering willingness to use naloxone to reverse opioid overdose, are a key component of a larger national strategy to address the crisis. In addition, overdose reversal with naloxone directly and immediately saves lives. Because of pharmacies’ ubiquity and pharmacists’ extensive clinical training, community pharmacies are well-positioned, in principle, to facilitate naloxone access and education. Objective: In 2022, a single-site pilot study of PharmNet, a community pharmacy intervention incorporating naloxone distribution, awareness building, and referral, showed promising outcomes for both naloxone and resource distribution in the community. As a next step, this study was intended to be a pilot randomized controlled trial of PharmNet in 7 pharmacies. However, due to circumstances outside of the study team’s control, data collection was unable to be fully completed as planned. In keeping with open research standards, we transparently report all available data from the study and discuss trial barriers and processes. We do so both to provide insights that may inform similar studies and to avoid the “file-drawer” (publication bias) problem, which can skew the aggregated scholarly literature through nonpublication of registered trial results or selective publication of findings affirming authors’ hypotheses. Methods: This paper reports an in-depth implementation study assessment, provides the available observational data, and discusses implementation considerations for similar studies in independent (eg, nonchain) community pharmacies. Results: Retrospective assessment of study outcomes and fidelity data provided for robust discussion around how resource differences in independent community pharmacies (vs well-resourced chain pharmacies), as well as high demands on staff, can affect intervention implementation, even when leadership is highly supportive. Conclusions: Community pharmacies, particularly independent community pharmacies, may require more support than anticipated to be successful when implementing a new intervention into practice, even if it might affect estimates of real-world effectiveness. Further implementation science research is needed specific to independent community pharmacies. All study elements are outlined in the International Registered Report Identifier (IRRID) PRR1-10.2196/42373. Although this paper reports results associated with that registration, results and conclusions should not be given the weight assigned to findings from a preregistered study. International Registered Report Identifier (IRRID): RR2-10.2196/42373 %M 38498037 %R 10.2196/54077 %U https://formative.jmir.org/2024/1/e54077 %U https://doi.org/10.2196/54077 %U http://www.ncbi.nlm.nih.gov/pubmed/38498037 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e51604 %T Engaging Cancer Care Physicians in Off-Label Drug Clinical Trials: Human-Centered Design Approach %A Parsell,Maren C %A Greenleaf,Morgan N %A Kombara,Greeshma G %A Sukhatme,Vikas P %A Lam,Wilbur A %+ Georgia Clinical and Translational Science Alliance, Emory University School of Medicine, Emory University, 1440 Clifton Road, Atlanta, GA, 30322, United States, 1 4048896149, maren.parsell@emory.edu %K human-centered design %K clinical trial design %K design methods %K clinical trial %K trial methodology %K barriers %K off-label drugs %K stakeholders %K cancer %K medications %D 2024 %7 15.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Using a human-centered design (HCD) approach can provide clinical trial design teams with a better understanding of the needs, preferences, and attitudes of clinical trial stakeholders. It can also be used to understand the challenges and barriers physician stakeholders face in initiating and completing clinical trials, especially for using off-label drugs (OLDs) to treat unmet clinical needs in cancer treatment. However, the HCD approach is not commonly taught in the context of clinical trial design, and few step-by-step guides similar to this study are available to demonstrate its application. Objective: This study aims to demonstrate the feasibility and process of applying an HCD approach to creating clinical trial support resources for physician stakeholders to overcome barriers to pursuing clinical trials for OLDs to treat cancer. Methods: An HCD approach was used to develop OLD clinical trial support concepts. In total, 45 cancer care physicians were contacted, of which 15 participated in semistructured interviews to identify barriers to prescribing OLDs or participating in cancer OLD clinical trials. Design research is qualitative—it seeks to answer “why” and “how” questions; thus, a sample size of 15 was sufficient to provide insight saturation to address the design problem. The team used affinity mapping and thematic analysis of qualitative data gathered from the interviews to inform subsequent web-based co-design sessions, which included creative matrix exercises and voting to refine and prioritize the ideas used in the final 3 recommended concepts. Results: The findings demonstrate the potential of HCD methods to uncover important insights into the barriers physicians face in participating in OLD clinical trials or prescribing OLDs, such as recruitment challenges, low willingness to prescribe without clinical data, and stigma. Notably, only palliative care participants self-identified as “frequent prescribers” of OLDs, despite high national OLD prescription rates among patients with cancer. Participants found the HCD approach engaging, with 60% (9/15) completing this study; scheduling conflicts caused most of the dropouts. Over 150 ideas were generated in 3 co-design sessions, with the groups voting on 15 priority ideas that the design team then refined into 3 final recommendations, especially focused on increasing the participation of physicians in OLD clinical trials. Conclusions: Using participatory HCD methods, we delivered 3 concepts for clinical trial support resources to help physician stakeholders overcome barriers to pursuing clinical trials for OLDs to treat cancer. Overall, integrating the HCD approach can aid in identifying important stakeholders, such as prescribing physicians; facilitating their engagement; and incorporating their perspectives and needs into the solution design process. This paper highlights the process, methods, and potential of HCD to improve cancer clinical trial design. Future work is needed to train clinical trial designers in the HCD approach and encourage adoption in the field. %M 38358789 %R 10.2196/51604 %U https://formative.jmir.org/2024/1/e51604 %U https://doi.org/10.2196/51604 %U http://www.ncbi.nlm.nih.gov/pubmed/38358789 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53453 %T Changepoint Detection in Heart Rate Variability Indices in Older Patients Without Cancer at End of Life Using Ballistocardiography Signals: Preliminary Retrospective Study %A Yanagisawa,Naotake %A Nishizaki,Yuji %A Yao,Bingwei %A Zhang,Jianting %A Kasai,Takatoshi %+ Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, 3-1-3 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan, 81 338133111, kasai-t@mx6.nisiq.net %K ballistocardiography %K BCG %K nonnvasive monitoring %K heart rate variability %K end-of-life care %K prognosis prediction %D 2024 %7 12.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: In an aging society such as Japan, where the number of older people continues to increase, providing in-hospital end-of-life care for all deaths, and end-of-life care outside of hospitals, such as at home or in nursing homes, will be difficult. In end-of-life care, monitoring patients is important to understand their condition and predict survival time; this information gives family members and caregivers time to prepare for the end of life. However, with no clear indicators, health care providers must subjectively decide if an older patient is in the end-of-life stage, considering factors such as condition changes and decreased food intake. This complicates decisions for family members, especially during home-based care. Objective: The purpose of this preliminary retrospective study was to determine whether and how changes in heart rate variability (HRV) indices estimated from ballistocardiography (BCG) occur before the date of death in terminally ill older patients, and ultimately to predict the date of death from the changepoint. Methods: This retrospective pilot study assessed the medical records of 15 older patients admitted to a special nursing home between August 2019 and December 2021. Patient characteristics and time-domain HRV indices such as the average normal-to-normal (ANN) interval, SD of the normal-to-normal (SDNN) interval, and root mean square of successive differences (RMSSD) from at least 2 months before the date of death were collected. Overall trends of indices were examined by drawing a restricted cubic spline curve. A repeated measures ANOVA was performed to evaluate changes in the indices over the observation period. To explore more detailed changes in HRV, a piecewise regression analysis was conducted to estimate the changepoint of HRV indices. Results: The 15 patients included 8 men and 7 women with a median age of 93 (IQR 91-96) years. The cubic spline curve showed a gradual decline of indices from approximately 30 days before the patients’ deaths. The repeated measures ANOVA showed that when compared with 8 weeks before death, the ratio of the geometric mean of ANN (0.90, 95% CI 0.84-0.98; P=.005) and RMSSD (0.83, 95% CI 0.70-0.99; P=.03) began to decrease 3 weeks before death. The piecewise regression analysis estimated the changepoints for ANN, SDNN, and RMSSD at –34.5 (95% CI –42.5 to –26.5; P<.001), –33.0 (95% CI –40.9 to –25.1; P<.001), and –35.0 (95% CI –42.3 to –27.7; P<.001) days, respectively, before death. Conclusions: This preliminary study identified the changepoint of HRV indices before death in older patients at end of life. Although few data were examined, our findings indicated that HRV indices from BCG can be useful for monitoring and predicting survival time in older patients at end of life. The study and results suggest the potential for more objective and accurate prognostic tools in predicting end-of-life outcomes. %M 38345857 %R 10.2196/53453 %U https://formative.jmir.org/2024/1/e53453 %U https://doi.org/10.2196/53453 %U http://www.ncbi.nlm.nih.gov/pubmed/38345857 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48609 %T A Codeveloped Web-Based Disability Disclosure Toolkit for Youth With Disabilities: Mixed Methods Pilot Evaluation %A Lindsay,Sally %A Kosareva,Polina %A Thomson,Nicole %A Stinson,Jennifer %+ Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Road, Toronto, ON, M4G 1R8, Canada, 1 416 425 6220, slindsay@hollandbloorview.ca %K disability %K disclosure %K employment %K vocational rehabilitation %K youth and young adults %K usability testing %K qualitative %K pilot study %K co-design %D 2023 %7 8.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Youth and young adults with disabilities experience many barriers in securing employment such as discrimination, inaccessible environments, and lack of support. Youth often need to decide whether and how they should disclose their need for accommodations to employers, which can help them to do their best at work. However, few evidence-based toolkits focusing on disability disclosure exist for youth with various types of disabilities. Supporting youth to develop self-advocacy skills is salient because they are an underrepresented and marginalized group in the labor market. Objective: The objective of this study was to conduct a pilot evaluation of a web-based toolkit to enhance disability disclosure for youth and young adults helping to advocate for their needs and request workplace accommodations. Methods: We conducted 2 in-person focus groups to codevelop a web-based disability disclosure toolkit, which was followed by a pilot evaluation with a pre-post survey. Primary outcomes focused on the relevance of the toolkit content, preliminary perceived impact on knowledge and confidence, and open-ended feedback on the usefulness of the toolkit. Secondary outcomes focused on effectiveness (ie, measures of self-determination). Results: A total of 14 youths with various types of disabilities took part in the study (aged 20-25 years; n=11, 78% female) including 3 who participated in the codevelopment focus group sessions and 11 youths who participated in the surveys. Our findings involved three main themes in the codevelopment sessions that included (1) disability disclosure and workplace accommodation experiences (ie, knowing when, whether, and how to disclose their disability and request workplace accommodations), (2) usefulness of the tool (ie, relatable content, format and design, and suggestions for further development), and (3) perceived impact of the toolkit (ie, navigating disclosure decisions and how to approach employers and develop other relevant employment skills). The survey findings showed that the majority of participants (10/11, 91%) reported that the toolkit increased or changed their knowledge or understanding of disability disclosure. Most participants (8/11, 73%) reported that the toolkit helped to increase their perceived confidence in their daily activities. The majority of participants (8/11, 73%) agreed or strongly agreed that the toolkit was easy to understand and comprehensive. Regarding the preliminary impact of the toolkit, participants did not demonstrate any significant improvements in self-determination (all P>.05). Conclusions: Our findings emphasize the importance of codeveloping a disability disclosure toolkit with youth to enhance its relevance for their needs. Our toolkit indicates preliminary potential as an educational resource for youth and young adults with disabilities as they search for and secure employment. Further research is needed to assess the impact of the tool with larger samples to understand the impact of workplace disability disclosure decisions for youth with disabilities. %M 38064264 %R 10.2196/48609 %U https://formative.jmir.org/2023/1/e48609 %U https://doi.org/10.2196/48609 %U http://www.ncbi.nlm.nih.gov/pubmed/38064264 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e49346 %T The Utility of a Novel Electrocardiogram Patch Using Dry Electrodes Technology for Arrhythmia Detection During Exercise and Prolonged Monitoring: Proof-of-Concept Study %A Fruytier,Lonneke A %A Janssen,Daan M %A Campero Jurado,Israel %A van de Sande,Danny AJP %A Lorato,Ilde %A Stuart,Shavini %A Panditha,Pradeep %A de Kok,Margreet %A Kemps,Hareld MC %+ Department of Cardiology, Máxima MC Eindhoven/Veldhoven, De Run 4600, Veldhoven, 5504 DB, Netherlands, 31 408888200, lonneke.fruytier@mmc.nl %K arrhythmia detection %K coronary artery disease %K ECG monitoring %K electrocardiogram %K exercise %K patch %K usability %D 2023 %7 30.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Accurate detection of myocardial ischemia and arrhythmias during free-living exercise could play a pivotal role in screening and monitoring for the prevention of exercise-related cardiovascular events in high-risk populations. Although remote electrocardiogram (ECG) solutions are emerging rapidly, existing technology is neither designed nor validated for continuous use during vigorous exercise. Objective: In this proof-of-concept study, we evaluated the usability, signal quality, and accuracy for arrhythmia detection of a single-lead ECG patch platform featuring self-adhesive dry electrode technology in individuals with chronic coronary syndrome. This sensor was evaluated during exercise and for prolonged, continuous monitoring. Methods: We recruited a total of 6 consecutive patients with chronic coronary syndrome scheduled for an exercise stress test (EST) as part of routine cardiac follow-up. Traditional 12-lead ECG recording was combined with monitoring with the ECG patch. Following the EST, the participants continuously wore the sensor for 5 days. Intraclass correlation coefficients (ICC) and Wilcoxon signed rank tests were used to assess the utility of detecting arrhythmias with the patch by comparing the evaluations of 2 blinded assessors. Signal quality during EST and prolonged monitoring was evaluated by using a signal quality indicator. Additionally, connection time was calculated for prolonged ECG monitoring. The comfort and usability of the patch were evaluated by a web-based self-assessment questionnaire. Results: A total of 6 male patients with chronic coronary syndrome (mean age 69.8, SD 6.2 years) completed the study protocol. The patch was worn for a mean of 118.3 (SD 5.6) hours. The level of agreement between the patch and 12-lead ECG was excellent for the detection of premature atrial contractions and premature ventricular contractions during the whole test (ICC=0.998, ICC=1.000). No significant differences in the total number of premature atrial contractions and premature ventricular contractions were detected neither during the entire exercise test (P=.79 and P=.18, respectively) nor during the exercise and recovery stages separately (P=.41, P=.66, P=.18, and P=.66). A total of 1 episode of atrial fibrillation was detected by both methods. Total connection time during recording was between 88% and 100% for all participants. There were no reports of skin irritation, erythema, or pain while wearing the patch. Conclusions: This proof-of-concept study showed that this innovative ECG patch based on self-adhesive dry electrode technology can potentially be used for arrhythmia detection during vigorous exercise. The results suggest that the wearable patch is also usable for prolonged continuous ECG monitoring in free-living conditions and can therefore be of potential use in cardiac rehabilitation and tele-monitoring for the prevention of exercise-related cardiovascular events. Future efforts will focus on optimizing signal quality over time and conducting a larger-scale validation study focusing on both arrhythmia and ischemia detection. %M 38032699 %R 10.2196/49346 %U https://formative.jmir.org/2023/1/e49346 %U https://doi.org/10.2196/49346 %U http://www.ncbi.nlm.nih.gov/pubmed/38032699 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47510 %T Sociodemographic Profile, Health Conditions, and Burden of Informal Caregivers of Older Adults in Brazil During the COVID-19 Pandemic: Cross-Sectional, Exploratory, Noninterventional, Descriptive Study %A Ferreira,Pâmela Moraes %A Gomes,Mateus Cunha %A de Araujo,Lucianne Nascimento %A Oliveira,Tainá Sayuri Onuma de %A Ferreira,Glenda %A Aben-Athar,Cintia %A da Silva,Silvio Eder Dias %A Cruz Ramos,Aline M P %A Rodrigues,Diego Pereira %A Sousa,Fabianne %+ Federal University of Para, Rua Augusto Correa 1, Belem, Brazil, 55 91981219404, fabiannesousa@hotmail.com %K informal caregivers %K older adult %K caregiver %K caregivers %K caregiving %K burden %K informal care %K cross-sectional %K gerontology %K older adults %K hospitalized %K overload %K burnout %D 2023 %7 23.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Demographic changes in the world population have resulted in an increasingly aging society, with a progressive increase in the number of people in situations of dependence, who require assistance from family members to meet their basic needs. Caring for older adults involves performing diverse activities, resulting in reduced free time and tiredness, and fulfilling the demands and expectations related to personal, family, physical, and social life, consequently compromising the quality of life of the caregiver. In this context, the informal caregiver of hospitalized older adults emerges as the focus of attention. Objective: The aim of this study was to describe the sociodemographic profile, health conditions, and burden of informal caregivers of older adults admitted to a university hospital in Brazil during the COVID-19 pandemic period. Methods: This is a cross-sectional, descriptive, and analytical study that was conducted with 25 informal caregivers of hospitalized older adults in a university hospital in Brazil between August and September 2022. Three instruments were applied: Caregiver Burden Inventory, sociodemographic questionnaire, and health conditions questionnaire. The data were analyzed using SPSS version 28.0. Descriptive (frequency and percentage) and inferential analyses were performed using 2-sided Student t test with 95% CIs. Results: Of the 25 interviewees, 18 (72%) were females, 17 (46%) were married or in a stable union, 14 (56%) completed secondary education, and 11 (44%) lived with the older adults who needed care. The average age of the participants was 44 (SD 12.8) years. Regarding their health conditions, most caregivers self-reported it as good (12/25, 48%). They provided care to their father or mother older than 70 years (14/25, 56%). The Caregiver Burden Inventory analysis showed that the caregivers were the most negatively impacted in the domains of personal life overload (mean 10.8, SD 3.46; P=.047) and physical overload (mean 10.6, SD 2.32; P=.02). Conclusions: In recent years, there has been an increase in the burden on informal caregivers of hospitalized older adults in Brazil, thereby impacting their personal and physical lives. The findings of our study show that health care professionals should be trained to promote health guidelines and actions to improve the personal and physical lives of the caregiver population in Brazil. %M 37995120 %R 10.2196/47510 %U https://formative.jmir.org/2023/1/e47510 %U https://doi.org/10.2196/47510 %U http://www.ncbi.nlm.nih.gov/pubmed/37995120 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45353 %T Analysis of Wastewater Samples to Explore Community Substance Use in the United States: Pilot Correlative and Machine Learning Study %A Severson,Marie A %A Onanong,Sathaporn %A Dolezal,Alexandra %A Bartelt-Hunt,Shannon L %A Snow,Daniel D %A McFadden,Lisa M %+ Division of Basic Biomedical Sciences, University of South Dakota, 414 E. Clark St., Vermillion, SD, 57069, United States, 1 605 658 6436, lisa.mcfadden@usd.edu %K methamphetamine %K opioids %K substance use disorder %K wastewater-based surveillance %K drug detection %K pilot study %K substance use %K detecting %K monitoring %K drugs %K surveillance %K community %D 2023 %7 26.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Substance use disorder and associated deaths have increased in the United States, but methods for detecting and monitoring substance use using rapid and unbiased techniques are lacking. Wastewater-based surveillance is a cost-effective method for monitoring community drug use. However, the examination of the results often focuses on descriptive analysis. Objective: The objective of this study was to explore community substance use in the United States by analyzing wastewater samples. Geographic differences and commonalities of substance use were explored. Methods: Wastewater was sampled across the United States (n=12). Selected drugs with misuse potential, prescriptions, and over-the-counter drugs and their metabolites were tested across geographic locations for 7 days. Methods used included wastewater assessment of substances and metabolites paired with machine learning, specifically discriminant analysis and cluster analysis, to explore similarities and differences in wastewater measures. Results: Geographic variations in the wastewater drug or metabolite levels were found. Results revealed a higher use of methamphetamine (z=–2.27, P=.02) and opioids-to-methadone ratios (oxycodone-to-methadone: z=–1.95, P=.05; hydrocodone-to-methadone: z=–1.95, P=.05) in states west of the Mississippi River compared to the east. Discriminant analysis suggested temazepam and methadone were significant predictors of geographical locations. Precision, sensitivity, specificity, and F1-scores were 0.88, 1, 0.80, and 0.93, respectively. Finally, cluster analysis revealed similarities in substance use among communities. Conclusions: These findings suggest that wastewater-based surveillance has the potential to become an effective form of surveillance for substance use. Further, advanced analytical techniques may help uncover geographical patterns and detect communities with similar needs for resources to address substance use disorders. Using automated analytics, these advanced surveillance techniques may help communities develop timely, tailored treatment and prevention efforts. %M 37883150 %R 10.2196/45353 %U https://formative.jmir.org/2023/1/e45353 %U https://doi.org/10.2196/45353 %U http://www.ncbi.nlm.nih.gov/pubmed/37883150 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47876 %T Effects of a 20-Week High-Intensity Strength Training Program on Muscle Strength Gain and Cardiac Adaptation in Untrained Men: Preliminary Results of a Prospective Longitudinal Study %A Pamart,Nicolas %A Drigny,Joffrey %A Azambourg,Hélène %A Remilly,Marion %A Macquart,Maxime %A Lefèvre,Alexandre %A Lahjaily,Kamal %A Parienti,Jean Jacques %A Rocamora,Amélia %A Guermont,Henri %A Desvergée,Antoine %A Ollitrault,Pierre %A Tournoux,Francois %A Saloux,Eric %A Normand,Hervé %A Reboursière,Emmanuel %A Gauthier,Antoine %A Hodzic,Amir %+ Inserm Comete, GIP Cyceron, Normandie Université, 2 Rue des Rochambelles, Caen, 14000, France, 33 0768221034, hodzic-a@chu-caen.fr %K actimetry %K athlete’s heart %K athletes %K echocardiography %K exercise %K isokinetic dynamometry %K muscle strength gain %K sports physiology %K strength training %K strengthening exercise %K untrained population %K weightlifting %D 2023 %7 24.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: As strength sports gain popularity, there is a growing need to explore the impact of sustained strength training on cardiac biventricular structure and function, an area that has received less attention compared to the well-established physiological cardiac adaptation to endurance training. Objective: This study aims to implement a 20-week high-intensity strength training program to enhance maximal muscle strength and evaluate its impact on cardiac biventricular adaptation in healthy, untrained men. Methods: A total of 27 healthy and untrained young men (mean age 22.8, SD 3.2 years) participated in a strength training program designed to increase muscle strength. The training program involved concentric, eccentric, and isometric exercise phases, conducted over a consecutive 20-week time frame with a frequency of 3 weekly training sessions. Participants were evaluated before and after 12 and 20 weeks of training through body composition analysis (bioelectrical impedance), a 12-lead resting electrocardiogram, 3D transthoracic echocardiography, cardiopulmonary exercise testing, and muscle isokinetic dynamometry. The progression of strength training loads was guided by 1-repetition maximum (RM) testing during the training program. Results: Of the initial cohort, 22 participants completed the study protocol. No injuries were reported. The BMI (mean 69.8, SD 10.8 kg/m² vs mean 72, SD 11 kg/m²; P=.72) and the fat mass (mean 15.3%, SD 7.5% vs mean 16.5%, SD 7%; P=.87) remained unchanged after training. The strength training program led to significant gains in 1-RM exercise testing as early as 4 weeks into training for leg extension (mean 69.6, SD 17.7 kg vs mean 96.5, SD 31 kg; P<.001), leg curl (mean 43.2, SD 9.7 kg vs mean 52.8, SD 13.4 kg; P<.001), inclined press (mean 174.1, SD 41.1 kg vs mean 229.2, SD 50.4 kg; P<.001), butterfly (mean 26.3, SD 6.2 kg vs mean 32.5, SD 6.6 kg; P<.001), and curl biceps on desk (mean 22.9, SD 5.2 kg vs mean 29.6, SD 5.2 kg; P<.001). After 20 weeks, the 1-RM leg curl, bench press, pullover, butterfly, leg extension, curl biceps on desk, and inclined press showed significant mean percentage gains of +40%, +41.1%, +50.3%, +63.5%, +80.1%, +105%, and +106%, respectively (P<.001). Additionally, the isokinetic evaluation confirmed increases in maximal strength for the biceps (+9.2 Nm), triceps (+11.6 Nm), quadriceps (+46.8 Nm), and hamstrings (+25.3 Nm). In this paper, only the training and muscular aspects are presented; the cardiac analysis will be addressed separately. Conclusions: This study demonstrated that a short-term high-intensity strength training program was successful in achieving significant gains in muscle strength among previously untrained young men. We intend to use this protocol to gain a better understanding of the impact of high-intensity strength training on cardiac physiological remodeling, thereby providing new insights into the cardiac global response in strength athletes. Trial Registration: ClinicalTrials.gov NCT04187170; https://clinicaltrials.gov/study/NCT04187170 %M 37874630 %R 10.2196/47876 %U https://formative.jmir.org/2023/1/e47876 %U https://doi.org/10.2196/47876 %U http://www.ncbi.nlm.nih.gov/pubmed/37874630 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e48057 %T Evaluation of a Portable Blood Gas Analyzer for Prehospital Triage in Carbon Monoxide Poisoning: Instrument Validation Study %A Lyon,Matthieu %A Fehlmann,Christophe Alain %A Augsburger,Marc %A Schaller,Thomas %A Zimmermann-Ivol,Catherine %A Celi,Julien %A Gartner,Birgit Andrea %A Lorenzon,Nicolas %A Sarasin,François %A Suppan,Laurent %+ Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Rue Gabrielle-Perret-Gentil 4, Geneva, 1211, Switzerland, 41 223723311, laurent.suppan@hcuge.ch %K carbon monoxide poisoning %K carbon monoxide intoxication %K prehospital triage %K Avoximeter 4000 %K CO-oximetry %K blood gas %K blood work %K pulse oximeter %K cohort study %K carbon monoxide %K poisoning %K sensor %K triage tool %K triage %K oximeter %K pilot study %K medical device %D 2023 %7 6.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Carbon monoxide (CO) poisoning is an important cause of morbidity and mortality worldwide. Symptoms are mostly aspecific, making it hard to identify, and its diagnosis is usually made through blood gas analysis. However, the bulkiness of gas analyzers prevents them from being used at the scene of the incident, thereby leading to the unnecessary transport and admission of many patients. While multiple-wavelength pulse oximeters have been developed to discriminate carboxyhemoglobin (COHb) from oxyhemoglobin, their reliability is debatable, particularly in the hostile prehospital environment. Objective: The main objective of this pilot study was to assess whether the Avoximeter 4000, a transportable blood gas analyzer, could be considered for prehospital triage. Methods: This was a monocentric, prospective, pilot evaluation study. Blood samples were analyzed sequentially with 2 devices: the Avoximeter 4000 (experimental), which performs direct measurements on blood samples of about 50 µL by analyzing light absorption at 5 different wavelengths; and the ABL827 FLEX (control), which measures COHb levels through an optical system composed of a 128-wavelength spectrophotometer. The blood samples belonged to 2 different cohorts: the first (clinical cohort) was obtained in an emergency department and consisted of 68 samples drawn from patients admitted for reasons other than CO poisoning. These samples were used to determine whether the Avoximeter 4000 could properly exclude the diagnosis. The second (forensic) cohort was derived from the regional forensic center, which provided 12 samples from documented CO poisoning. Results: The mean COHb level in the clinical cohort was 1.7% (SD 1.8%; median 1.2%, IQR 0.7%-1.9%) with the ABL827 FLEX versus 3.5% (SD 2.3%; median 3.1%, IQR 2.2%-4.1%) with the Avoximeter 4000. Therefore, the Avoximeter 4000 overestimated COHb levels by a mean difference of 1.8% (95% CI 1.5%-2.1%). The consistency of COHb readings by the Avoximeter 4000 was excellent, with an intraclass correlation coefficient of 0.97 (95% CI 0.93-0.99) when the same blood sample was analyzed repeatedly. Using prespecified cutoffs (5% in nonsmokers and 10% in smokers), 3 patients (4%) had high COHb levels according to the Avoximeter 4000, while their values were within the normal range according to the ABL827 FLEX. Therefore, the specificity of the Avoximeter 4000 in this cohort was 95.6% (95% CI 87%-98.6%), and the overtriage rate would have been 4.4% (95% CI 1.4%-13%). Regarding the forensic samples, 10 of 12 (83%) samples were positive with both devices, while the 2 remaining samples were negative with both devices. Conclusions: The limited difference in COHb level measurements between the Avoximeter 4000 and the control device, which erred on the side of safety, and the relatively low overtriage rate warrant further exploration of this device as a prehospital triage tool. %M 37801355 %R 10.2196/48057 %U https://formative.jmir.org/2023/1/e48057 %U https://doi.org/10.2196/48057 %U http://www.ncbi.nlm.nih.gov/pubmed/37801355 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49902 %T Improving Medication Safety in Cancer Services for Ethnic Minority Consumers: Protocol for a Pilot Feasibility and Acceptability Study of a Co-Designed Consumer Engagement Intervention %A Newman,Bronwyn %A Chin,Melvin %A Robinson,Louisa %A Chauhan,Ashfaq %A Manias,Elizabeth %A Wilson,Carlene %A Harrison,Reema %+ Australian Institute for Health Innovation, Macquarie University, Centre for Health Systems and Safety Research Australian Institute of Health Innovation, Level 6, 75 Talavera Road, Sydney, 2109, Australia, 61 298506627, bronwyn.newman@mq.edu.au %K co-design %K ethnic minority %K health care equity %K patient engagement %K patient participation %K patient safety %K medication safety %K medication therapy %K medication therapy management %K patient transfer %K consumer %K engagement %K intervention %K ethnic minority %D 2023 %7 18.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: People from ethnic minorities are often exposed to unsafe care contributing to poorer health care outcomes. Medication safety is a high-risk area requiring intervention to improve care outcomes. Using an adapted, experience-based co-design process with cancer service staff and patients from ethnic minorities, a medication communication tool was created: Making it Meaningful (MiM). Objective: We aim to test whether the MiM tool is feasible and acceptable for use with ethnic minority consumers in cancer services in Australia. Methods: A single site, controlled before and after this pilot study, will be used. Patients from Mandarin- and Russian-speaking backgrounds are eligible for inclusion. In total, 40 patients from these cultural backgrounds will be recruited and stratified by language to the intervention and control groups, with 20 participants in the intervention and 20 in the control group. Further, 4 health practitioners will be recruited and trained to use the MiM. Clinicians providing care for patients in the intervention will use the MiM during their usual appointment while providing medication communication using standard care processes for the control group. Telephone surveys will be conducted with participants at 3 time points, T1 before the intervention, T2 1 week post intervention, and T3 1 month post intervention, to assess knowledge and self-efficacy in medication management, perceived usability, and acceptability of the MiM. Qualitative interviews with clinicians who have used the MiM will be conducted 1 month postintervention to explore their perceptions of MiM feasibility and acceptability. Results: Ethical approval for this research has been provided by the South Eastern Sydney Area Health Human Research Ethics Committee (HRECXXX). Bilingual field-workers, 1 Mandarin-speaking and 1 Russian-speaking, are contacting eligible patients to enroll. It is anticipated that recruitment will be completed by October 2023, with data collection completed by December 2023. Conclusions: Using experience-based co-design, we identified communication about medication, particularly between appointments, as a key issue impacting the safety of care for patients from ethnic minorities accessing cancer services. Increasing consumer engagement in medication management was identified as a strategy to reduce medication safety problems in cancer care; the MiM strategy was developed to address this issue. It is anticipated that by using the MiM, patient knowledge about prescribed medications and confidence in medication management will increase. Evidence from the pilot study will be used to inform a full-scale trial of the MiM tool with a range of ethnic minority communities accessing cancer services. A full-scale trial will seek to determine whether the MiM intervention is effective in knowledge and confidence about medication management, but also whether this improves patient outcomes in cancer care. Trial Registration: Australian New Zealand Clinical Trials ACTRN12622001260718p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384658&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/49902 %M 37721784 %R 10.2196/49902 %U https://www.researchprotocols.org/2023/1/e49902 %U https://doi.org/10.2196/49902 %U http://www.ncbi.nlm.nih.gov/pubmed/37721784 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46865 %T Colorectal Cancer Screening Decision Based on Predicted Risk: Protocol for a Pilot Randomized Controlled Trial %A Plys,Ekaterina %A Bulliard,Jean-Luc %A Chaouch,Aziz %A Durand,Marie-Anne %A van Duuren,Luuk A %A Brändle,Karen %A Auer,Reto %A Froehlich,Florian %A Lansdorp-Vogelaar,Iris %A Corley,Douglas A %A Selby,Kevin %+ Center for Primary Care and Public Health (Unisanté), University of Lausanne, Route de Berne 113, Lausanne, 1010, Switzerland, ekaterina.plys@unisante.ch %K colorectal cancer screening %K personalized screening %K risk communication %K shared decision-making %K screening behavior %K Switzerland %D 2023 %7 7.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Incidence of and mortality from colorectal cancer (CRC) can be effectively reduced by screening with the fecal immunochemical test (FIT) or colonoscopy. Individual risk to develop CRC within 15 years varies from <1% to >15% among people aged 50 to 75 years. Communicating personalized CRC risk and appropriate screening recommendations could improve the risk-benefit balance of screening test allocations and optimize the use of limited colonoscopy resources. However, significant uncertainty exists regarding the feasibility and efficacy of risk-based screening. Objective: We aim to study the effect of communicating individual CRC risk and a risk-based recommendation of the FIT or colonoscopy on participants’ choice of screening test. We will also assess the feasibility of a larger clinical trial designed to evaluate the impact of personalized screening on clinical outcomes. Methods: We will perform a pilot randomized controlled trial among 880 residents aged 50 to 69 years eligible to participate in the organized screening program of the Vaud canton, Switzerland. Participants will be recruited by mail by the Vaud CRC screening program. Primary and secondary outcomes will be self-assessed through questionnaires. The risk score will be calculated using the open-source QCancer calculator that was validated in the United Kingdom. Participants will be stratified into 3 groups—low (<3%), moderate (3% to <6%), and high (≥6%) risk—according to their 15-year CRC risk and randomized within each risk stratum. The intervention group participants will receive a newly designed brochure with their personalized risk and screening recommendations. The control group will receive the usual brochure of the Vaud CRC screening program. Our primary outcome, measured using a self-administered questionnaire, is appropriate screening uptake 6 months after the intervention. Screening will be defined as appropriate if participants at high risk undertake colonoscopy and participants at low risk undertake the FIT. We will also measure the acceptability of the risk score and screening recommendations and the psychological factors influencing screening behavior. We will also assess the feasibility of a full-scale randomized controlled trial. Results: We expect that a total sample of 880 individuals will allow us to detect a difference of 10% (α=5%) between groups. The main outcome will be analyzed using a 2-tailed chi-squared test. We expect that appropriate screening uptake will be higher in the intervention group. No difference in overall screening uptake is expected. Conclusions: We will test the impact of personalized risk information and screening recommendations on participants’ choice of screening test in an organized screening program. This study should advance our understanding of the feasibility of large-scale risk-based CRC screening. Our results may provide insights into the optimization of CRC screening by offering screening options with a better risk-benefit balance and optimizing the use of resources. Trial Registration: ClinicalTrials.gov NCT05357508; https://www.clinicaltrials.gov/study/NCT05357508 International Registered Report Identifier (IRRID): DERR1-10.2196/46865 %M 37676720 %R 10.2196/46865 %U https://www.researchprotocols.org/2023/1/e46865 %U https://doi.org/10.2196/46865 %U http://www.ncbi.nlm.nih.gov/pubmed/37676720 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47887 %T Effects of Melatonin on Glycemic Variability in Type 2 Diabetes Mellitus: Protocol for a Crossover, Double-Blind, Placebo-Controlled Trial %A Martorina,Wagner %A Tavares,Almir %+ Institute of Biological Sciences, Federal University of Minas Gerais, Av Pres Antônio Carlos, 6627, Belo Horizonte, 31270-901, Brazil, 55 31 3409 5000, wmartorina@yahoo.com %K type 2 diabetes mellitus %K glycemic control %K melatonin %K randomized controlled trial %K cross-over studies %K T2DM %K glucose %K glycemic variability %K circadian rhythm %D 2023 %7 16.8.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Glycemic variability is recognized as a significant factor contributing to the development of micro- and macrovascular complications in individuals with type 2 diabetes mellitus (T2DM). Numerous studies have shown that melatonin, a hormone involved in regulating various biological rhythms, including those related to glucose regulation, such as hunger, satiety, sleep, and circadian hormone secretion (ie, cortisol, growth hormone, catecholamines, and insulin), is deficient in individuals with T2DM. This raises an important question: Could melatonin replacement potentially reduce glycemic variability in these patients? This warrants investigation as a novel approach to improving glycemic control and reducing the risk of complications associated with T2DM. Objective: We aimed to investigate whether melatonin replacement in individuals with T2DM who supposedly have melatonin deficiency can positively impact the regulation of insulin secretion rhythms and improve insulin sensitivity, ultimately resulting in a reduction in glycemic variability. Methods: This study will use a crossover, randomized, double-blind, placebo-controlled trial design. Patients with T2DM in group 1 will receive 3 mg of melatonin at 9:00 PM in the first week, undergo a washout period in the second week, and receive a placebo in the third week (melatonin-washout-placebo). Group 2 will be randomized to receive a placebo-washout-melatonin sequence (3 mg). Capillary blood glucose levels will be measured at 6 different times before and after meals during the last 3 days of the first and third weeks. The study aims to compare the mean differences in blood glucose levels and the coefficient of glycemic variability in patients receiving melatonin and placebo during the first and third weeks. After analyzing the initial results, the number of needed patients will be recalculated. If the recalculated number is higher than 30, new participants will be recruited. Thirty patients with T2DM will be randomized into the 2 groups: melatonin-washout-placebo or placebo-washout-melatonin. Results: Participant recruitment took place between March 2023 to April 2023. In all, 30 participants were eligible and completed the study. We expect that patients will show different glycemic variability on the days they receive placebo or melatonin. Studies on melatonin and glycemic control have shown both positive and negative results. We hope that there will be a positive outcome regarding glycemic variability (ie, a reduction in glycemic variability), as melatonin has a well-described chronobiotic effect in the literature. Conclusions: This study aims to determine whether melatonin supplementation can effectively reduce glycemic variability in patients with T2DM. The crossover design is necessary due to the multiple variables involved in the circadian variations of glucose, including diet, physical activity, sleep parameters, and pharmacological treatments. The relatively low cost of melatonin and its potential role in reducing the severe complications associated with T2DM have motivated this research effort. Furthermore, the indiscriminate use of melatonin in current times makes conducting this study essential to evaluate the effect of this substance in patients with T2DM. Trial Registration: Brazilian Registry of Clinical Trials RBR-6wg54rb; https://ensaiosclinicos.gov.br/rg/RBR-6wg54rb International Registered Report Identifier (IRRID): DERR1-10.2196/47887 %M 37410852 %R 10.2196/47887 %U https://www.researchprotocols.org/2023/1/e47887 %U https://doi.org/10.2196/47887 %U http://www.ncbi.nlm.nih.gov/pubmed/37410852 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45871 %T A Peer-Based Intervention to Increase HIV and Sexually Transmitted Infection Testing Among Latinx Immigrant Sexual Minority Men in the US Pacific Northwest: Pilot Randomized Controlled Trial Conducted During the COVID-19 Pandemic %A Lee,Jane J %A Robles,Gabriel %A Leyva Vera,Christopher A %A Orellana,E Roberto %A Graham,Susan M %A Nguyen,Anh-Minh %A Wei,Yingying %A Sanchez,Abraham Hernandez %A Dombrowski,Julia C %A Simoni,Jane M %+ School of Social Work, University of Washington, 4101 15th Avenue NE, Seattle, WA, 98105, United States, 1 206 616 8984, janejlee@uw.edu %K HIV prevention %K self-testing %K sexually transmitted infections %K preexposure prophylaxis %K peers %K Latinx immigrants %D 2023 %7 12.7.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Hispanic and Latinx gay, bisexual, and other sexual minority men (SMM) are disproportionately affected by HIV in the United States. With the availability of self-testing services, HIV and sexually transmitted infection (STI) testing may be more accessible for Latinx immigrant SMM who face obstacles to obtaining HIV-related services. Combining the potential of self-testing kits and the influence of peer educators may present an opportunity to increase HIV and STI testing and preexposure prophylaxis (PrEP) uptake or linkage to HIV care among Latinx immigrant SMM. Objective: This study aimed to develop and pilot a peer intervention to distribute HIV and STI self-testing kits and provide peer counseling based on the information-motivation-behavioral skills model to increase PrEP uptake and HIV and STI testing among Latinx immigrant SMM. Our evaluation focused on determining the differences in HIV testing, STI testing, and PrEP uptake outcomes between the intervention and control groups. Methods: We conducted semistructured interviews with community stakeholders to elicit factors to consider for training and intervention. The interview findings informed the development of the intervention and peer training protocols. We piloted the intervention with Latinx immigrant SMM and randomly assigned participants to the intervention group, who received peer counseling and HIV and STI self-testing kits, or the control group, who only received peer counseling. We administered baseline, 1-week, 6-week, and 12-week follow-up surveys to assess behaviors related to HIV testing, STI testing, and PrEP uptake. Owing to the COVID-19 pandemic, the intervention components were delivered via web-based modalities. Chi-square tests were performed to examine the associations between HIV testing, STI testing, and PrEP motivation and behaviors across the study arms (intervention vs control). We conducted Cramer V test to determine the strength of the association between study arm and each of the outcome variables. We also assessed the impact of the COVID-19 pandemic on participants. Results: Overall, 50 (intervention, n=30 and control, n=20) Latinx immigrant SMM participated in the program. Participants reported life disruptions owing to COVID-19, with 68% (34/50) reporting job loss after the declaration of the pandemic. After intervention participation, a higher proportion of participants in the intervention group reported having been tested for STIs (76% vs 36.8%; P=.01; Cramer V=0.394). Among the participants in the intervention group, 91% (21/23) reported being motivated to use PrEP compared with 59% (10/17) in the control group (P=.02; Cramer V=0.385). Conclusions: By facilitating access to HIV and STI testing through peer-delivered information, motivational support, and behavioral skills training as well as the provision of self-testing kits, our intervention demonstrated the potential to increase HIV prevention behaviors in Latinx immigrant SMM. Peer-based programs that offer self-testing and internet-based modes of accessing information may be a feasible strategy for reaching Latinx immigrant SMM. Trial Registration: ClinicalTrials.gov NCT03922126; https://clinicaltrials.gov/ct2/show/NCT03922126 %M 37436792 %R 10.2196/45871 %U https://formative.jmir.org/2023/1/e45871 %U https://doi.org/10.2196/45871 %U http://www.ncbi.nlm.nih.gov/pubmed/37436792 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47461 %T Assessment and Documentation of Social Determinants of Health Among Health Care Providers: Qualitative Study %A Yelton,Brooks %A Rumthao,Jancham Rachel %A Sakhuja,Mayank %A Macauda,Mark M %A Donelle,Lorie %A Arent,Michelle A %A Yang,Xueying %A Li,Xiaoming %A Noblet,Samuel %A Friedman,Daniela B %+ Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Greene Street, Suite 557, Columbia, SC, 29208, United States, 1 803 576 5815, dfriedma@mailbox.sc.edu %K social determinants of health %K SDOH %K health equity %K Healthy People 2030 %K interviews %K thematic analysis %K health care worker %K health care provider %K health equity %K barrier %K facilitator %K qualitative study %K web-based %K patient health %K well-being %K community health status %D 2023 %7 3.7.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Research clearly demonstrates social determinants of health (SDOH) impact health outcomes. Provider consideration of patient SDOH in prevention and treatment planning is critical for improved health care quality and health equity. Despite awareness of the connections between SDOH and improved population health, research demonstrates few providers document patient SDOH. Objective: This qualitative study aimed to better understand the barriers and facilitators of SDOH assessment, documentation, and referral in different health care settings and roles. Methods: Individual semistructured interviews were conducted with practicing health care providers in South Carolina between August 25, 2022, and September 2, 2022. Participants were recruited via community partners’ web-based newsletters or listservs using a purposive sampling design. An interview guide with 19 questions was used to explore the following research question: How do SDOH impact patient health and what are the facilitators and barriers experienced by multidisciplinary health care providers assessing and documenting patient SDOH? Results: Participants (N=5) included a neonatal intensive care unit registered nurse, a nurse practitioner, a certified nurse midwife, a family and preventive medicine physician, and a counselor (licensed clinical social worker) with careers spanning 12 to 32 years. Participant responses are presented according to the following 5 themes: participants’ understanding of SDOH for the patient population, assessment and documentation practices, referrals to other providers and community-based resources, barriers and facilitators of SDOH assessment and documentation, and SDOH assessment and documentation training preferences. Overall, participants were aware of the importance of including patient SDOH in assessment and intervention but noted a variety of institutional and interpersonal barriers to assessment and documentation, including time constraints, perceptions of stigma around discussion of SDOH, and limited referral protocols. Conclusions: Incentivizing inclusion of patient SDOH in health care must be facilitated from the top down, so assessment and documentation can be universally implemented in a pragmatic way that works for providers in a variety of roles and settings for the betterment of health care quality, health equity, and improved population health outcomes. Partnering with community organizations can serve to augment health care organizations’ resource and referral availability for addressing patients’ social needs. %M 37399064 %R 10.2196/47461 %U https://formative.jmir.org/2023/1/e47461 %U https://doi.org/10.2196/47461 %U http://www.ncbi.nlm.nih.gov/pubmed/37399064 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43015 %T A Virtual Reality App Intervention to Improve Concussion Recognition and Reporting in Athletes Aged 9 to 12 Years: Development and Pilot Testing %A Sullivan,Lindsay %A McKenzie,Lara B %A Roberts,Kristin %A Recker,Robyn %A Schwebel,David C %A Pommering,Thomas %A Yang,Jingzhen %+ Center for Injury Research and Policy, Abigail Wexner Research Institute, Nationwide Children's Hospital, RBIII-WB5403, 700 Children's Drive, Columbus, OH, 43205, United States, 1 614 355 5852, ginger.yang@nationwidechildrens.org %K concussion %K education %K sports %K athlete %K athletic %K virtual reality %K youth %K child %K pediatric %K head injury %K symptom reporting %K symptom recognition %K patient education %K brain injury %K user experience %K user centered design %D 2023 %7 26.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Existing concussion education programs for preteen athletes typically do not result in sustained improvements in concussion symptom recognition or reporting behaviors. Virtual reality (VR) technology offers an innovative tool that may improve concussion symptom recognition and reporting behaviors among preteen athletes. Objective: We aimed to describe the design and development of a VR concussion education app, Make Play Safe (MPS), and present findings on the usability and preliminary efficacy of MPS in improving concussion recognition and reporting intentions among soccer athletes aged 9-12 years. Methods: A collaborative user-centered design process was implemented to develop and evaluate MPS, a semi-immersive VR concussion education app designed to address two behavioral outcomes in preteen athletes aged 9-12 years: (1) recognizing concussion and (2) reporting concussion. The development of MPS occurred in three phases: (1) design and development, (2) usability testing, and (3) preliminary efficacy testing. During phase 1, consultations were completed with 6 experts. Additionally, 5 interviews with children who had a history of concussion were conducted to collect feedback about the proof of concept of MPS. During phase 2, a participatory workshop with 11 preteen athletes and a small group discussion with 6 parents and 2 coaches were conducted to explore the usefulness and acceptability of MPS from the perspective of end users. Finally, phase 3 included preliminary efficacy testing with 33 soccer athletes aged 9-12 years to examine changes in concussion-related knowledge, attitudes, and reporting intentions from pre- to postintervention. The data generated from each phase of this study informed the development of the final version of the proof of concept of the VR concussion education app, MPS. Results: Experts positively rated the features of MPS and noted that the design and content were innovative and age-appropriate. Preteens with a history of concussion indicated the scenarios and symptoms portrayed in the app represented well what they experienced while concussed. Further, they stated that the app would be an engaging way for children to learn about concussions. The 11 healthy children in the workshop perceived the app positively, noting that the scenarios were informative and engaging. Results from preliminary efficacy testing revealed increases in many athletes’ knowledge and reporting intentions from pre- to postintervention. Others demonstrated no significant changes or a decrease in knowledge, attitudes, or reporting intentions from pre- to postintervention. Group-level changes in concussion knowledge and intention to report concussions were statistically significant (P<.05), while changes in attitudes toward reporting concussions were not (P=.08). Conclusions: Results suggest VR technology may be an effective and efficient tool to equip preteen athletes with the requisite knowledge and skills to recognize and report future concussions. Further research is recommended to examine the use of VR as an effective strategy to improve concussion-reporting behaviors in preteen athletes. %M 37234027 %R 10.2196/43015 %U https://formative.jmir.org/2023/1/e43015 %U https://doi.org/10.2196/43015 %U http://www.ncbi.nlm.nih.gov/pubmed/37234027 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e40897 %T Patient-Centered Outcomes Associated With a Novel Office-Based Opioid Treatment Program in a District Health Department: Mixed Methods Pilot Study %A Coles,Theresa %A Chen,Hillary %A Des Marais,Andrea %A Sachdeva,Nidhi %A Bush,Christopher %A Macon Harrison,Lisa %A Guthrie,Shauna %+ Department of Population Health Sciences, Duke University School of Medicine, 215 Morris St., Durham, NC, 27701, United States, 1 919 613 7994, theresa.coles@duke.edu %K integrated care %K mental health %K opioid treatment %K opioid use disorder %K opioid %K patient-centered outcomes %K public health %D 2023 %7 24.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Granville and Vance counties have some of the highest opioid-related death rates in North Carolina, and have significant unmet needs with regard to opioid treatment. Medication for opioid use disorder (MOUD) is the most effective evidence-based approach to address opioid use disorder. Despite demonstrated efficacy and substantial need, access to MOUD is still insufficient in many parts of the United States. In order to connect patients with needed MOUD services, the district health department, Granville Vance Public Health (GVPH), established an office-based opioid treatment (OBOT) program. Objective: In this formative pilot study, we sought to describe patients’ goals and outcomes in a program delivered at a rural local health department using an integrated care approach. Methods: We used a mixed methods concurrent nested research design. The primary method of investigation was one-on-one qualitative interviews with active OBOT patients (n=7) focused on patients’ goals and perceived impacts of the program. Trained interviewers followed a semistructured interview guide developed iteratively by the study team. The secondary method was a descriptive quantitative analysis (79 patients; 1478 visits over 2.5 years) of treatment retention and patient-reported outcomes (anxiety and depression). Results: Participants in the OBOT program were 39.6 years of age on average, and 25.3% (20/79) were uninsured. The average retention in the program was 18.4 months. The proportion of individuals in the program with moderate to severe depression (Patient Health Questionnaire-9 scores ≥10) decreased between program initiation (66%, 23/35) and at the most recent assessment (34%, 11/32). In qualitative interviews, participants credited the OBOT program for reducing or stopping the use of opioids and other substances (eg, marijuana, cocaine, and benzodiazepines). Many participants noted how the program helped them manage withdrawal symptoms and cravings, which helped them feel more in control of their use. Participants also attributed improvements in quality of life to the OBOT program, such as improved relationships with loved ones, improved mental and physical health, and improved financial stability. Conclusions: Initial data show promising patient outcomes for active GVPH OBOT participants, including reduction in opioid use and improvements in quality of life. As a pilot study, a limitation of this study is a lack of a comparison group. However, this formative project demonstrates promising patient-centered outcome improvements for GVPH OBOT participants. %M 37223963 %R 10.2196/40897 %U https://formative.jmir.org/2023/1/e40897 %U https://doi.org/10.2196/40897 %U http://www.ncbi.nlm.nih.gov/pubmed/37223963 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45248 %T Osteopathy in the Early Diagnosis and Management of Degenerative Cervical Myelopathy: National Survey %A Brannigan,Jamie F M %A Mowforth,Oliver D %A Rogers,Matthew %A Wood,Helen %A Karimi,Zahabiya %A Kotter,Mark R N %A Davies,Benjamin M %+ Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Addenbrookes' Hospital, Cambridge, CB2 0QQ, United Kingdom, 44 7825545404, jb2172@cam.ac.uk %K cervical cord %K myelopathy %K spondylosis %K stenosis %K disc herniation %K ossification posterior longitudinal ligament %K degeneration %K disability %K diagnosis %K degenerative cervical myelopathy %K spine %K osteopathy %K neurodegenerative condition %K surgical decompression %K neurodegeneration %K survey %D 2023 %7 9.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Degenerative cervical myelopathy (DCM) is a common and disabling neurodegenerative condition. Surgical decompression is the only evidence-based treatment to halt disease progression; however, diagnosis and access to timely treatment are often delayed, which contribute to significant disability and dependence. Supporting early diagnosis and access to timely treatment is a critical priority. Exploring these challenges, Myelopathy.org has observed that people with DCM may seek osteopathy care for their symptoms, both before and after diagnosis. Objective: This study aimed to describe the current interaction between osteopaths and people with DCM and understand how this may be targeted to enhance the DCM diagnostic pathway. Methods: Registered osteopaths in the United Kingdom completed a web-based survey hosted by the Institute of Osteopathy, as part of their institute’s 2021 census. Responses were collected from February to May 2021. Demographic information about the respondents was captured, including age, gender, and ethnicity. Professional information captured included the year of qualification; region of practice; type of practice; and number of undiagnosed, operated diagnosed, and unoperated diagnosed DCM cases encountered per year. The completion of the survey was voluntary; however, a prize draw incentive was offered to participants. Results: The demographics were heterogenous for the 547 practitioners who completed the survey. There was representation from a wide range of demographic groups, including the level of experience, gender, age, and the region of United Kingdom. At least 68.9% (377/547) of osteopaths reported encounters with DCM each year. Osteopaths most frequently encountered patients with undiagnosed DCM, with a mean of 3 patient encounters per year. This compares to 2 encounters per year with patients with diagnosed DCM. The level of practitioner experience was positively correlated with the detection of undiagnosed DCM (P<.005). The influence of practitioner experience was corroborated by a subgroup analysis looking at the relationship between practitioner age on the detection of undiagnosed DCM. Osteopaths older than 54 years encountered an average of 4.2 cases per year, whereas those younger than 35 years detected 2.9 cases per year. Osteopaths in private clinics reported encounters with a greater mean number (4.4) of undiagnosed DCM cases per year than osteopaths in other clinic types (3.0). Conclusions: Osteopaths reported that they frequently consult people with DCM, including those suspected to have undiagnosed or presurgical DCM. Given this concentrated presentation of early DCM and a workforce professionally trained to examine musculoskeletal disease, osteopaths could have an important role in accelerating access to timely treatment. We included a decision support tool and specialist referral template as a tool to support onward care. %M 37159244 %R 10.2196/45248 %U https://formative.jmir.org/2023/1/e45248 %U https://doi.org/10.2196/45248 %U http://www.ncbi.nlm.nih.gov/pubmed/37159244 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42606 %T Evaluating a Social-Emotional Training Program for Refugee Families and Service Providers: Pilot Study %A Al-Janaideh,Redab %A Speidel,Ruth %A Colasante,Tyler %A Malti,Tina %+ Research and Assessment, Centre for Leadership and Learning, York Region District School Board, 300 Harry Walker Pkwy S, Newmarket, York Region, ON, L3Y 8E2, Canada, 1 905 727 0022, redab.al-janaideh@yrdsb.ca %K social-emotional training %K strengths-based %K mental health %K refugee children %K refugee caregivers %K service providers %D 2023 %7 5.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Refugee children are often exposed to adversities that present a threat to their healthy development. Promoting refugee children’s social-emotional capacities may be an opportune, strengths-based avenue to nurture their resilience, coping strategies, and mental health outcomes amid these risks. Furthermore, supporting caregivers’ and service providers’ capacities to provide strengths-based care may result in more sustainable, caring environments for refugee children. However, culturally adapted initiatives that aim to promote social-emotional capacities and mental health in refugee children, caregivers, and service providers are limited. Objective: In this pilot study, we aimed to assess the feasibility and efficacy of a brief, 3-week social-emotional training program for refugee caregivers of children aged between 2 and 12 years and service providers who support refugees. This study had 3 central objectives. First, we examined whether refugee caregivers’ and service providers’ knowledge of core social-emotional concepts increased from pre- to posttraining, whether these increases were maintained 2 months later, and whether caregivers and service providers reported a high use of training-based strategies after the training. Second, we assessed if refugee caregivers reported any improvements in their children’s social-emotional capacities and mental health from pre- to posttraining and 2 months later. Finally, we evaluated whether caregivers and service providers experienced any improvements in their own mental health symptoms from pre- to posttraining and 2 months later. Methods: A total of 50 Middle Eastern refugee caregivers of children (n=26) aged between 2 and 12 years and service providers (n=24) were recruited using convenience sampling and participated in a 3-week training program. Training sessions were delivered via a web-based learning management system and involved a combination of asynchronous (video-based) and synchronous (web-based live group) sessions. The training was evaluated using an uncontrolled pre-, post-, and 2-month follow-up design. Caregivers and service providers reported their understanding of social-emotional concepts and mental health at pre-, post-, and 2 months after training and reported their use of training strategies after training. Caregivers reported their children’s social-emotional capacities and mental health through a presurvey, a series of postsurveys (after each module session and 1 week after the training), and a 2-month follow-up survey. The participants also reported their demographic information. Results: Caregivers’ and service providers’ knowledge of social-emotional concepts increased significantly from pre- to posttraining, and the service providers’ knowledge increase was sustained at the 2-month follow-up. Both caregivers and service providers reported high levels of strategy use. Furthermore, 2 markers of children’s social-emotional development (ie, emotion regulation and sadness over wrongdoing) improved after training. Conclusions: The findings highlight the potential of strengths-based, culturally adapted social-emotional initiatives to support refugee caregivers’ and service providers’ abilities to provide high-quality social-emotional care to refugee children. %M 37145855 %R 10.2196/42606 %U https://formative.jmir.org/2023/1/e42606 %U https://doi.org/10.2196/42606 %U http://www.ncbi.nlm.nih.gov/pubmed/37145855 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42418 %T A Novel Capacity-Strengthening Intervention for Frontline Harm Reduction Workers to Support Pre-exposure Prophylaxis Awareness-Building and Promotion Among People Who Use Drugs: Formative Research and Intervention Development %A Glick,Jennifer L %A Zhang,Leanne %A Rosen,Joseph G %A Yaroshevich,Karla %A Atiba,Bakari %A Pelaez,Danielle %A Park,Ju Nyeong %+ Department of Health, Behavior, and Society, Bloomberg School of Public Health, Johns Hopkins University, 624 N Broadway, Suite 904A, Baltimore, MD, 21205, United States, 1 3603937426, jglick5@jhu.edu %K formative research %K harm reduction %K intervention development %K pre-exposure prophylaxis (PrEP) %K people who use drugs (PWUD) %D 2023 %7 13.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: HIV prevalence among people who use drugs (PWUD) in Baltimore, Maryland, is higher than among the general population. Pre-exposure prophylaxis (PrEP) is a widely available medication that prevents HIV transmission, yet its usefulness is low among PWUD in Baltimore City and the United States. Community-level interventions to promote PrEP uptake and adherence among PWUD are limited. Objective: We describe the development of a capacity-strengthening intervention designed for frontline harm reduction workers (FHRWs) to support PrEP awareness-building and promotion among PWUD. Methods: Our study was implemented in 2 phases in Baltimore City, Maryland. The formative phase focused on a qualitative exploration of the PrEP implementation environment, as well as facilitators and barriers to PrEP willingness and uptake, among cisgender women who use drugs. This work, as well as the existing literature, theory, and feedback from our community partners, informed the intervention development phase, which used an academic-community partnership model. The intervention involved a 1-time, 2-hour training with FHRWs aimed at increasing general PrEP knowledge and developing self-efficacy promoting PrEP in practice (eg, facilitating PrEP dialogues with clients, supporting client advancement along a model of PrEP readiness, and referring clients to PrEP services). In a separate paper, we describe the conduct and results of a mixed methods evaluation to assess changes in PrEP-related knowledge, attitudes, self-efficacy, and promotion practices among FHRWs participating in the training. Results: The pilot was developed from October to December 2021 and implemented from December 2021 through April 2022. We leveraged existing relationships with community-based harm reduction organizations to recruit FHRWs into the intervention. A total of 39 FHRWs from 4 community-based organizations participated in the training across 4 sessions (1 in-person, 2 online synchronous, and 1 online asynchronous). FHRW training attendees represented a diverse range of work cadres, including peer workers, case managers, and organizational administrators. Conclusions: This intervention could prevent the HIV burden among PWUD by leveraging the relationships that FHRWs have with PWUD and by supporting advancement along the PrEP continuum. Given suboptimal PrEP uptake among PWUD and the limited number of interventions designed to address this gap, our intervention offers an innovative approach to a burgeoning public health problem. If effective, our intervention has the potential to be further developed and scaled up to increase PrEP awareness and uptake among PWUD worldwide. %M 37052977 %R 10.2196/42418 %U https://formative.jmir.org/2023/1/e42418 %U https://doi.org/10.2196/42418 %U http://www.ncbi.nlm.nih.gov/pubmed/37052977 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e39834 %T Ohnut Versus a Waitlist Control for the Self-management of Endometriosis-Associated Deep Dyspareunia: Protocol for a Pilot Randomized Controlled Trial %A Zhang,Sandy X J %A MacLeod,Rebecca G K %A Parmar,Gurkiran %A Orr,Natasha L %A Wahl,Kate J %A Noga,Heather %A Albert,Arianne %A Flannigan,Ryan %A Brotto,Lori A %A Yong,Paul J %+ British Columbia Women’s Centre for Pelvic Pain & Endometriosis, British Columbia Women’s Hospital & Health Centre, 4500 Oak st., Vancouver, BC, Canada, 1 604 875 2534, Paul.Yong@vch.ca %K endometriosis %K dyspareunia %K randomized controlled trial %K self-management %K pilot project %K pilot study %K women's health %K pain %K gynecology %K gynecologist %K sexual health %K sexual medicine %D 2023 %7 27.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Endometriosis-associated deep dyspareunia is associated with reduced sexual quality of life, lower self-esteem, and impaired sexual function. Objective: The primary objective is to assess the acceptability of a phallus length reducer (brand name: Ohnut [OhnutCo]), which is a buffer worn over the penis or a penetrating object to reduce endometriosis-associated deep dyspareunia, and the feasibility of a definitive randomized controlled trial (RCT). The secondary objective is to obtain estimates of the effectiveness of the buffer. An embedded substudy will explore the acceptability and the preliminary validity and reliability of a vaginal insert for the self-assessment of deep dyspareunia. Methods: Ours is an investigator-initiated, 2-arm RCT. We will recruit 40 patient participants with diagnosed endometriosis between the ages of 19 and 49 years, as well as their sexual partners. The participating couples will be randomized in a 1:1 ratio into the experimental arm or the waitlist control arm. The length of the study period will be 10 weeks, during which time all participants will record deep dyspareunia severity following each episode of sexual intercourse. In weeks 1 to 4, all patient participants will record deep dyspareunia severity at each sexual encounter. In weeks 5 to 10, participants in the experimental arm will use the buffer during vaginal penetration; participants in the waitlist control arm will continue engaging in vaginal penetration as usual. Participants will complete questionnaires for assessing measures of anxiety, depression, and sexual function at baseline, at 4 weeks, and at 10 weeks. In the substudy, patient participants will self-assess dyspareunia by using a vaginal insert on 2 occasions, at least 1 week apart. The primary outcomes—the acceptability and feasibility of the buffer—will be assessed with descriptive statistics, and the secondary outcome—phallus length reducer effectiveness—will be assessed by using an analysis of covariance–based approach. For the vaginal insert, we will assess acceptability, test-retest reliability, and convergent validity via correlation analyses comparing the use of the insert to clinical examination in terms of dyspareunia assessment outcomes. Results: Our pilot will provide initial data on the acceptability and effectiveness of the buffer and the feasibility of the study methodology. The results from our study are expected to be submitted for publication by the spring of 2023. As of September 2021, we have consented 31 couples into the study. Conclusions: Our study will provide preliminary evidence for the self-assessment and management of endometriosis-associated deep dyspareunia. The findings will inform the decision to proceed to a definitive RCT. Trial Registration: ClinicalTrials.gov NCT04370444; https://clinicaltrials.gov/ct2/show/NCT04370444 International Registered Report Identifier (IRRID): DERR1-10.2196/39834 %M 36972117 %R 10.2196/39834 %U https://www.researchprotocols.org/2023/1/e39834 %U https://doi.org/10.2196/39834 %U http://www.ncbi.nlm.nih.gov/pubmed/36972117 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e38540 %T A Web-Based Gender-Sensitive Educational Simulation on Vocational Rehabilitation for Service Providers Working With Youth With Disabilities: Pilot Evaluation %A Lindsay,Sally %A Thomson,Nicole %A Moll,Sandra %A Colantonio,Angela %A Stinson,Jennifer %+ Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Road, Toronto, ON, M4G 1R8, Canada, 1 416 425 6220 ext 3654, slindsay@hollandbloorview.ca %K continuing professional development %K CME %K medical education %K professional development %K continuing education %K gender-sensitive care %K online %K gender %K education %K simulator %K simulation %K clinician %K pilot %K youth %K young %K disabled %K disability %K child %K pediatric %K disabilities %K trainee %K community %K training %K tool %K rehabilitation %K feedback %K survey %D 2023 %7 24.3.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Although there is a need for gender-specific health care, especially within the context of vocational rehabilitation for youth with disabilities, clinicians, trainees, and community service providers commonly report lacking training in gender-sensitive approaches. Therefore, an educational tool designed for clinicians working with youth, that addresses how to approach such issues, could help clinicians to augment the care they provide. Objective: The objective of our study was to conduct a pilot evaluation of an educational simulation for health care and service providers focusing on gender-sensitive approaches within the context of supporting youth with disabilities in vocational rehabilitation. Methods: We conducted a survey from May to September 2021 to assess the relevance of the simulation content, preliminary perceived impact on gender-sensitive knowledge and confidence, and open-ended feedback of a web-based gender-sensitive educational simulation. A total of 12 health care providers from a variety of professions who had experience working with youth in the context of vocational rehabilitation participated in the survey (11 women and 1 man). Results: Most participants reported that the content of the simulation was relevant and comprehensive. The majority of participants reported that the simulation helped to increase their perceived knowledge or understanding of the topic, changed their perceived understanding of their intervention or approach, and informed their perceived confidence. Our qualitative findings from the open-ended questions highlighted three main themes: (1) relevance of the simulation content, (2) perceived impact for clinical practice (ie, gender-sensitive language and communication and building rapport with patients), and (3) perceived impact on organizational processes (ie, practices, policy, and privacy). Conclusions: Our educational simulation shows preliminary potential as an educational tool for service providers working with youth who have a disability within the context of vocational rehabilitation. Further research is needed to assess the impact of the tool with larger samples. %M 36961496 %R 10.2196/38540 %U https://formative.jmir.org/2023/1/e38540 %U https://doi.org/10.2196/38540 %U http://www.ncbi.nlm.nih.gov/pubmed/36961496 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e37549 %T Web-Based Digital Storytelling for Endometriosis and Pain: Qualitative Pilot Study %A Howard,A Fuchsia %A Noga,Heather %A Parmar,Gurkiran %A Kennedy,Lan %A Aragones,Sarah %A Bassra,Roop %A Gelfer,Lauren %A Lopez de Arbina,Edurne %A Sutherland,Jessica %A Allaire,Catherine %A Oliffe,John L %A Currie,Leanne M %A Yager,Holly %A Yong,Paul J %+ School of Nursing, The University of British Columbia, 201-2211 Wesbrook Mall, Vancouver, BC, V6T 2B5, Canada, 1 6048224372, fuchsia.howard@ubc.ca %K digital storytelling %K endometriosis %K pain %K chronic pain %K painful sex %K dyspareunia %K integrated knowledge translation %K patient-oriented research %K community-based participatory research %K qualitative research %K arts-based research %K group therapy %K sex therapy %D 2023 %7 14.3.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Endometriosis is a complex chronic disease characterized by pain, including painful sex, that can contribute to considerable sexual function, self-esteem, and relationship challenges. Digital storytelling is an arts-based, participatory methodology wherein individuals create and share their illness experiences in detailing their lived experiences. Objective: The study objective was to pilot-test a web-based digital storytelling workshop focused on endometriosis to understand storytellers’ experiences of workshop participation. We assessed the feasibility of story cocreation and sharing, including the emotional impact of workshop participation, the acceptability of the workshop for the subject matter, and the storytellers’ willingness to share their stories with broader audiences as a method for knowledge translation. Methods: This study used a community-based participatory methodology supplemented with patient-oriented research and integrated knowledge translation. Study participants, referred to as storytellers, cocreated 3- to 5-minute individual digital stories about their lived experiences of endometriosis during a web-based workshop (comprising five 2-hour sessions over 6 weeks) facilitated by The Center for Digital Storytelling. Data were collected through participant observations at the workshop, storyteller weekly reflective journals, and an end-of-workshop focus group interview with storytellers. These data were analyzed using a qualitative interpretive description approach. Results: A total of 5 women and 1 nonbinary storyteller aged 19 to 39 years who had experienced endometriosis for 4 to 22 years participated in the study. We characterized storytelling workshop participation and the acceptability of story cocreation by describing participants’ experiences of opportunity, commitment, and connection; complex emotions that were healing; and a desire to share. Feasibility was demonstrated through 100% engagement in the workshops. All 6 storytellers reported feeling empowered by publicly sharing their cocreated digital stories through social media and the Sex, Pain & Endometriosis website. Conclusions: Despite the complexities of the story-building process, the workshop and the cocreation and sharing of digital stories were feasible. The storytellers found that this process allowed for emotional healing and personal empowerment by offering a unique way to talk about painful sex, which also facilitated a connection among those in the workshop. The use of digital storytelling as a knowledge translation tool shows promise, and this approach also has potential as a therapeutic intervention. %M 36917164 %R 10.2196/37549 %U https://formative.jmir.org/2023/1/e37549 %U https://doi.org/10.2196/37549 %U http://www.ncbi.nlm.nih.gov/pubmed/36917164 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42792 %T Screening of Mild Cognitive Impairment Through Conversations With Humanoid Robots: Exploratory Pilot Study %A Yoshii,Kenta %A Kimura,Daiki %A Kosugi,Akihiro %A Shinkawa,Kaoru %A Takase,Toshiro %A Kobayashi,Masatomo %A Yamada,Yasunori %A Nemoto,Miyuki %A Watanabe,Ryohei %A Ota,Miho %A Higashi,Shinji %A Nemoto,Kiyotaka %A Arai,Tetsuaki %A Nishimura,Masafumi %+ Department of Informatics, Graduate School of Intergraded Science and Technology, Shizuoka University, 3-5-1 Johoku, Naka-ku, Hamamatsu, 432-8011, Japan, 81 70 8432 8701, yoshii.kenta.14@shizuoka.ac.jp %K mild cognitive impairment %K Alzheimer disease %K neuropsychiatric symptoms %K neuropsychological assessment %K simple screening %K humanoid robot %K robot %K symptoms %K neuropsychological %K monitoring %D 2023 %7 13.1.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The rising number of patients with dementia has become a serious social problem worldwide. To help detect dementia at an early stage, many studies have been conducted to detect signs of cognitive decline by prosodic and acoustic features. However, many of these methods are not suitable for everyday use as they focus on cognitive function or conversational speech during the examinations. In contrast, conversational humanoid robots are expected to be used in the care of older people to help reduce the work of care and monitoring through interaction. Objective: This study focuses on early detection of mild cognitive impairment (MCI) through conversations between patients and humanoid robots without a specific examination, such as neuropsychological examination. Methods: This was an exploratory study involving patients with MCI and cognitively normal (CN) older people. We collected the conversation data during neuropsychological examination (Mini-Mental State Examination [MMSE]) and everyday conversation between a humanoid robot and 94 participants (n=47, 50%, patients with MCI and n=47, 50%, CN older people). We extracted 17 types of prosodic and acoustic features, such as the duration of response time and jitter, from these conversations. We conducted a statistical significance test for each feature to clarify the speech features that are useful when classifying people into CN people and patients with MCI. Furthermore, we conducted an automatic classification experiment using a support vector machine (SVM) to verify whether it is possible to automatically classify these 2 groups by the features identified in the statistical significance test. Results: We obtained significant differences in 5 (29%) of 17 types of features obtained from the MMSE conversational speech. The duration of response time, the duration of silent periods, and the proportion of silent periods showed a significant difference (P<.001) and met the reference value r=0.1 (small) of the effect size. Additionally, filler periods (P<.01) and the proportion of fillers (P=.02) showed a significant difference; however, these did not meet the reference value of the effect size. In contrast, we obtained significant differences in 16 (94%) of 17 types of features obtained from the everyday conversations with the humanoid robot. The duration of response time, the duration of speech periods, jitter (local, relative average perturbation [rap], 5-point period perturbation quotient [ppq5], difference of difference of periods [ddp]), shimmer (local, amplitude perturbation quotient [apq]3, apq5, apq11, average absolute differences between the amplitudes of consecutive periods [dda]), and F0cov (coefficient of variation of the fundamental frequency) showed a significant difference (P<.001). In addition, the duration of response time, the duration of silent periods, the filler period, and the proportion of fillers showed significant differences (P<.05). However, only jitter (local) met the reference value r=0.1 (small) of the effect size. In the automatic classification experiment for the classification of participants into CN and MCI groups, the results showed 66.0% accuracy in the MMSE conversational speech and 68.1% accuracy in everyday conversations with the humanoid robot. Conclusions: This study shows the possibility of early and simple screening for patients with MCI using prosodic and acoustic features from everyday conversations with a humanoid robot with the same level of accuracy as the MMSE. %M 36637896 %R 10.2196/42792 %U https://formative.jmir.org/2023/1/e42792 %U https://doi.org/10.2196/42792 %U http://www.ncbi.nlm.nih.gov/pubmed/36637896 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 11 %P e42010 %T Behavior Change Training for Health Professionals: Evaluation of a 2-Hour Workshop %A Mullan,Barbara %A Liddelow,Caitlin %A Haywood,Darren %A Breare,Hayley %+ enAble Institute, Faculty of Health Sciences, Curtin University, Kent Street, Bentley, 6102, Australia, 61 08 9266 2468, barbara.mullan@curtin.edu.au %K behaviour change %K psychology %K psychological %K BCT %K health professional %K health care professional %K medical education %K health care provider %K continuing education %K professional development %K theory of planned behaviour %K COM-B %K workshop %K intervention %K clinical practice %D 2022 %7 18.11.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Rates of noncommunicable diseases continue to rise worldwide. Many of these diseases are a result of engaging in risk behaviors. Without lifestyle and behavioral intervention, noncommunicable diseases can worsen and develop into more debilitating diseases. Behavioral interventions are an effective strategy to reduce the burden of disease. Behavior change techniques can be described as the “active ingredients” in behavior change and address the components that need to be altered in order for the target behavior to change. Health professionals, such as pharmacists and nurses, can engage in opportunistic behavior change with their patients, to encourage positive health behaviors. Objective: We aimed to develop, implement, and evaluate a behavior change workshop targeted at health professionals in Australia, with the goal of increasing knowledge of behavior change techniques and psychological variables. Methods: A prospective study design was used to develop and evaluate a 2-hour behavior change workshop targeted at health professionals. The workshop was developed based on the Capability, Opportunity, Motivation, and Behavior Model and had five core objectives: (1) to detail the role of health professionals in delivering optimal care, (2) to demonstrate opportunities to change behavior, (3) to describe principles of behavior change, (4) to explain behavior change techniques, and (5) to determine the most appropriate behavior change techniques to use and when to use them. A total of 10 workshops were conducted. To evaluate the workshops and identify any potential long-term changes in behavior, we collected pre- and postworkshop data on knowledge and psychological constructs from the attendees. Results: A final sample of 41 health professionals comprising general practitioners, nurses, and pharmacists completed the pre- and postworkshop surveys. Following the workshops, there were significant improvements in knowledge of behavior change techniques (t40=–5.27, P<.001), subjective norms (t40=–3.49, P=.001), descriptive norms (t40=–3.65, P<.001), perceived behavioral control (t40=–3.30, P=.002), and intention (t36=–3.32, P=.002); each had a large effect size. There was no significant difference in postworkshop attitude (t40=0.78, P=.44). The participants also found the workshops to be highly acceptable. Conclusions: A 2-hour, theoretically informed workshop designed to facilitate the use of behavior change techniques by health professionals was shown to be largely effective. The workshops resulted in increases in knowledge, descriptive and subjective norms, perceived behavioral control, and intention, but not in attitude. The intervention was also shown to be highly acceptable, with the large majority of participants deeming the intervention to be needed, useful, appropriate, and applicable, as well as interesting and worth their time. Future research should examine the lasting impacts of the workshop on health professionals’ practices. %M 36399382 %R 10.2196/42010 %U https://formative.jmir.org/2022/11/e42010 %U https://doi.org/10.2196/42010 %U http://www.ncbi.nlm.nih.gov/pubmed/36399382 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 10 %P e40164 %T Social Determinants of Health and Diabetes-Related Distress in Patients With Insulin-Dependent Type 2 Diabetes: Cross-sectional, Mixed Methods Approach %A Levy,Natalie K %A Park,Agnes %A Solis,Daniela %A Hu,Lu %A Langford,Aisha T %A Wang,Binhuan %A Rogers,Erin S %+ Department of Medicine, New York University Grossman School of Medicine, 462 First Ave, New York, NY, 10016, United States, 1 212 263 8924, natalie.levy@nyulangone.org %K social determinants of health %K income %K socioeconomic %K cross sectional %K insulin %K diabetic %K HbA1c %K barrier %K diabetes-related distress %K type 2 diabetes %K ambulatory care %K healthcare %K health care %K distress %K epidemiology %K T2DM %K diabetes %D 2022 %7 12.10.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Social determinants of health (SDOH) refer to the social, economic, and psychosocial conditions that influence health. Lower levels of SDOH factors including income, education, and employment are associated with a higher prevalence of diabetes, poorer glycemic control, and increased diabetes-related mortality. Few studies have conducted a comprehensive evaluation of multiple SDOH factors in a population with type 2 diabetes mellitus (T2DM). Objective: This study aimed to identify the range of SDOH challenges—including diabetes-related distress—that impact patients with insulin-dependent diabetes at an urban safety-net clinic using the 5-domain SDOH framework developed by the Healthy People 2020 initiative. Methods: The pilot study used a cross-sectional, mixed methods approach. Participants were recruited from 3 programs within a general internal medicine clinic that provides ambulatory care for patients with uncontrolled T2DM. We administered an investigator-developed SDOH survey based on the Healthy People 2020 framework and the validated Diabetes Distress Scale (DDS), which assesses 4 domains of diabetes-related distress. One-on-one interviews were conducted to gain in-depth information about challenges. Results: In total, 57 participants had an average hemoglobin A1c level of 11.0% (SD 2.6%). Overall, 92% (52/57) of participants had a barrier in at least one SDOH domain. SDOH challenges were most commonly reported in the domain of Health and Health Care (84%, 48/57), followed by Economic Stability (54%, n=31), Neighborhood and Built Environment (53%, n=30), Education and Health Literacy (47%, n=27), and Social and Community context (37%, n=21). The mean overall DDS score was 2.09 (SD 0.84), where scores of ≥2 indicate distress. Further, 79% (45/57) of participants had at least moderate diabetes-related distress in one of the 4 DDS domains. General themes that emerged from participant interviews included job interference with healthy behaviors, concerns about burdening others, challenges communicating with providers, and difficulty getting appointments in a timely manner. Conclusions: We found high levels of SDOH barriers across all 5 domains of the Center for Disease Control and Prevention’s Healthy People 2020 framework, including significant levels of diabetes-related distress. Future programs to address SDOH barriers in patients with uncontrolled insulin-dependent diabetes should consider screening for and focusing on a wide range of challenges. %M 36222807 %R 10.2196/40164 %U https://formative.jmir.org/2022/10/e40164 %U https://doi.org/10.2196/40164 %U http://www.ncbi.nlm.nih.gov/pubmed/36222807 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 9 %P e37252 %T Extracurricular Humanism in Medicine Initiative and Medical Student Wellness: Retrospective Study %A Auckley,Elizabeth Diane %A Barbee,Jeff %A Verbeck,Nicole %A McCambridge,Tracie %A Stone,Linda %A Garvin,Jennifer %+ The Ohio State University College of Medicine, 370 W 9th Ave, Columbus, OH, 43210, United States, 1 4402926035, elizabeth.auckley@osumc.edu %K humanism %K extracurricular %K stress %K burnout %K medical student %K student %K academic success %K wellness %D 2022 %7 16.9.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Humanism in Medicine Initiative (HIMI), an extracurricular program at Ohio State University College of Medicine (OSUCOM) with 27 subgroups, fosters the humanities. Stress and burnout among first- and second-year medical students are prevalent across the United States. Solutions for stress among first- and second-year medical students have been proposed, but no gold standard exists. The relationship of humanism with stress and burnout has yet to be described in the literature. Objective: This study investigates the relationship between participation in the HIMI and stress, burnout, and academic success among first- and second-year medical students. Methods: First- and second-year medical students enrolled at OSUCOM between August 2018 and August 2019 were recruited. Attendance in the HIMI and membership records were used to measure their participation. Curricular examination scores and those on Step 1 of United States Medical Licensing Examination (USMLE) were used to measure academic success. Stress and burnout were measured using the Maslach Burnout Inventory and the Perceived Stress Scale. Results: In total, 412 students were enrolled with 362 (87%) students participating in HIMI. Those with high participation were more often Black, Asian, female, or with a humanities undergraduate major compared to the overall study population. There were significant relationships between Gold Humanism Honors Society (GHHS) induction and participation of first- and second-year medical students in service- (χ21=5.8, P<.05) or leadership-focused (χ21=19.3, P<.001) HIMI groups. Medium levels of participation in the HIMI were associated with significantly higher stress. Performance on the Step 1 USMLE was not significantly associated with participation levels in the HIMI (low=233.7 vs high=238.0; P=.10). Conclusions: The HIMI is an extracurricular program vastly utilized by first- and second-year medical students at OSUCOM and did not impact Step 1 USMLE scores. Medium participation in the HIMI was associated with higher stress, and service- and leadership-focused HIMI participation was associated with a higher level of induction to the GHHS. This study identifies areas for future studies to understand the relationship of the HIMI with stress and academic success. %M 36112401 %R 10.2196/37252 %U https://formative.jmir.org/2022/9/e37252 %U https://doi.org/10.2196/37252 %U http://www.ncbi.nlm.nih.gov/pubmed/36112401 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 8 %P e35079 %T Utility and Acceptability of a Brief Type 2 Diabetes Visual Animation: Mixed Methods Feasibility Study %A Alyami,Mohsen %A Serlachius,Anna %A Law,Mikaela %A Murphy,Rinki %A Almigbal,Turky H %A Lyndon,Mataroria %A Batais,Mohammed A %A Algaw,Rawabi K %A Broadbent,Elizabeth %+ Department of Psychological Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Private Bag 92109, Auckland, 1142, New Zealand, 64 9 923 0003, e.broadbent@auckland.ac.nz %K illness perception %K visualization %K animation %K intervention %K mobile phone %K type 2 diabetes mellitus %D 2022 %7 9.8.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Visualizations of illness and treatment processes are promising interventions for changing unhelpful perceptions and improving health outcomes. However, these are yet to be tested in patients with type 2 diabetes mellitus (T2DM). Objective: This study assesses the cross-cultural acceptability and potential effectiveness of a brief visual animation of T2DM at changing unhelpful illness and treatment perceptions and self-efficacy among patients and family members in 2 countries, New Zealand and Saudi Arabia. Health care professionals’ views on visualization are also explored. Methods: A total of 52 participants (n=39, 75% patients and family members and n=13, 25% health care professionals) were shown a 7-minute T2DM visual animation. Patients and family members completed a questionnaire on illness and treatment perceptions and self-efficacy before and immediately after the intervention and completed semistructured interviews. Health care professionals completed written open-ended questions. Means and 95% CIs are reported to estimate potential effectiveness. Inductive thematic analysis was conducted on qualitative data. Results: All participants rated the visual animation as acceptable and engaging. Four main themes were identified: animation-related factors, impact of the animation, animation as an effective format for delivering information, and management-related factors. Effect sizes (ranged from 0.10 to 0.56) suggested potential effectiveness for changing illness and treatment perceptions and self-efficacy among patients and family members. Conclusions: Visualizations are acceptable and may improve the perceptions of patients’ with diabetes in a short time frame. This brief visual animation has the potential to improve current T2DM education. A subsequent randomized controlled trial to investigate the effects on illness and treatment perceptions, adherence, glycemic control, and unplanned hospital admission is being prepared. %M 35943787 %R 10.2196/35079 %U https://formative.jmir.org/2022/8/e35079 %U https://doi.org/10.2196/35079 %U http://www.ncbi.nlm.nih.gov/pubmed/35943787 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 8 %P e34949 %T Communications Through Contemporary Tools of Information and Communication Technology: Cross-sectional Study Evaluating Health Among Separated Family Members %A Nishikitani,Mariko %A Ariyoshi,Mie %A Nohara,Yasunobu %A Umihara,Junko %+ Medical Information Center, Kyushu University Hospital, 3-1-1 Collabo 2-705, Maidashi Higashi-ku, Fukuoka, 812-8582, Japan, 81 92 642 6475, nishikitani.mariko.585@m.kyushu-u.ac.jp %K family relations %K interpersonal communication %K internet use %K smartphone %K home environment %K psychosocial functioning %D 2022 %7 3.8.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The number of single-living workers separated from their spouses and families has been increasing due to the need to create a balance between life and work. Workers are assigned everywhere in globalized workplaces while also caring for their family members in the context of Japan’s aging society. At the same time, the mental and health status of persons living separately from their families is a matter of concern. The development of interpersonal communication means using information and communications technology (ICT) tools and the internet is remarkable, enabling simultaneous 2-way communication across distances and national borders. The easy accessibility to simultaneous communication is expected to improve the psychosocial status of isolated family members. Objective: This study aims to clarify the health benefits of ICT by using a psychosocial health assessment, the characteristics of ICT tools, and the frequency of communication among the workers and their families who live separately. Methods: This was a cross-sectional study planned and conducted in Japan. Study participants, including adults who live separately from other family members or have separately living family members due to work, were recruited to answer a web response survey about ICT usage status, health status, and life and society evaluation. This study recruited 73 participants divided into 2 groups by their communication tools and frequencies, and their separated life, health, and psychosocial status were statistically compared. Results: Among the 73 study participants, 15 were categorized in the high communication–skilled (HCS) group that used both types of ICT tools to communicate frequently: “live,” such as video chat and voice call, and “nonlive,” such as SMS text message service and email. A simple comparison between the HCS and reference groups showed significant differences in the cohesion with the neighborhood (P=.03), perceived social position (P=.01), and happiness (P<.001); however, there were no significant differences in the health (psychological distress, P=.08; self-rated health, P=.07), lifestyle (drinking, P>.99; current smoking, P=.37), and dyadic trust in family members living separately (P=.80). Further, in a multivariate regression analysis adjusted for confounding factors, such as educational history, age, gender, and job status, poor subjective health showed a prevalence odds ratio of less than 1 (OR 0.17, 95% CI 0.03-1.02). The HCS group showed significant positive relationships in the cohesion score with the neighborhood (P=.01; β=2.40, 95% CI 0.56-4.24), perceived social position (P=.03; β=1.17, 95% CI 0.11-2.23), and happiness score (P=.002; β=1.46, 95% CI 0.58-2.34) in the same multivariate regression models. Conclusions: This study suggested that people who frequently communicate with separated family members by taking advantage of various ICT tools can maintain a better mental state and better social relations among those who live alone and are separated from their families. %M 35921127 %R 10.2196/34949 %U https://formative.jmir.org/2022/8/e34949 %U https://doi.org/10.2196/34949 %U http://www.ncbi.nlm.nih.gov/pubmed/35921127 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 7 %P e35655 %T Comparison of the Impact of Insulin Degludec U100 and Insulin Glargine U300 on Glycemic Variability and Oxidative Stress in Insulin-Naive Patients With Type 2 Diabetes Mellitus: Pilot Study for a Randomized Trial %A Vrebalov Cindro,Pavle %A Krnić,Mladen %A Modun,Darko %A Vuković,Jonatan %A Tičinović Kurir,Tina %A Kardum,Goran %A Rušić,Doris %A Šešelja Perišin,Ana %A Bukić,Josipa %+ Department of Endocrinology, University Hospital Split, Šoltanska 1, Split, 21000, Croatia, 385 981772113, mladen.krnic@gmail.com %K type two diabetes mellitus %K type 2 diabetes mellitus %K insulin degludec %K insulin glargine U300 %K glucose variability %K oxidative stress %K insulin %K diabetes %K diabetic %K glycemic variability %K glycaemic variability %K RCT %K pilot %K control trial %K clinical trial %D 2022 %7 8.7.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: There is an ongoing discussion about possible differences between insulin degludec (IDeg-100) and glargine U300 (IGlar-300). There is little data and head-to-head comparison of IDeg-100 and IGlar-300 regarding their simultaneous impact on glycemic variability and oxidative stress in patients with type 2 diabetes mellitus (T2DM). Objective: In our randomized, open-label, crossover study, we compared the impact of IDeg-100 and IGlar-300 on glycemic variability and oxidative stress in insulin-naive patients with T2DM. Methods: We recruited a total of 25 adult patients with T2DM (7 females) whose diabetes was uncontrolled (HbA1c ≥7.5%) on two or more oral glucose-lowering drugs; a total of 22 completed the study. Mean age was 57.3 (SD 6.99) years and duration of diabetes was 9.94 (SD 5.01) years. After the washout period, they were randomized alternately to first receive either IDeg-100 or IGlar-300 along with metformin. Each insulin was administered for 12 weeks and then switched. At the beginning and end of each phase, biochemical and oxidative stress parameters were analyzed. On 3 consecutive days prior to each control point, patients performed a 7-point self-monitoring of blood glucose profile. Oxidative stress was assessed by measuring thiol groups and hydroperoxides (determination of reactive oxygen metabolites test) in serum. Results: IGlar-300 reduced mean glucose by 0.02-0.13 mmol/L, and IDeg-100 reduced glucose by 0.10-0.16 mmol/L, with no significant difference. The reduction of the coefficient of glucose variation also did not show a statistically significant difference. IGlar-300 increased thiols by 0.08 µmol/L and IDeg-100 increased thiols by 0.15 µmol/L, with no significant difference (P=.07) between them. IGlar-300 reduced hydroperoxides by 0.040 CARR U and IDeg-100 increased hydroperoxides by 0.034 CARR U, but the difference was not significant (P=.12). Conclusions: The results of our study do not show a significant difference regarding glycemic variability between patients receiving either insulin IDeg-100 or IGlar-300, although IGlar-300 showed greater dispersion of data. No significant difference in oxidative stress was observed. In a larger study, doses of insulins should be higher to achieve significant impact on glycemic parameters and consequently on glycemic variability and oxidative stress. Trial Registration: ClinicalTrials.gov, NCT04692415; https://clinicaltrials.gov/ct2/show/NCT04692415 %M 35802405 %R 10.2196/35655 %U https://formative.jmir.org/2022/7/e35655 %U https://doi.org/10.2196/35655 %U http://www.ncbi.nlm.nih.gov/pubmed/35802405 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 6 %P e35194 %T Possible Contribution of Meaning in Life in Patients With Chronic Pain and Suicidal Ideation: Observational Study %A Chytas,Vasileios %A Costanza,Alessandra %A Mazzola,Viridiana %A Luthy,Christophe %A Galani,Vasiliki %A Bondolfi,Guido %A Cedraschi,Christine %+ Department of Psychiatry, Service of Liaison Psychiatry and Crisis Intervention, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 4, Geneva, 1205, Switzerland, 41 079 553 41 55, Vasileios.Chytas@hcuge.ch %K meaning in life %K suicidal ideation %K chronic pain %K pain %K suicide %D 2022 %7 13.6.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Chronic pain is associated with an elevated risk of suicidal ideation (SI). Objective: We aimed to examine if the presence or the search for Meaning in Life (MiL) are associated with less SI and explore whether MiL profiles emerge in our cohort. These profiles can be described as high presence–high search, high presence–low search, low presence–low search, and low presence–high search. Methods: In this observational study, we recruited 70 patients who were referred to the Multidisciplinary Pain Center of the Geneva University Hospitals and who answered positively to question 9 on the Beck Depression Inventory, 2nd Edition, investigating SI. Patients who agreed to participate in the study were further investigated; they participated in a structured diagnostic interview to screen for psychiatric diagnoses. During this interview, they completed the Meaning in Life Questionnaire and the semistructured Scale for Suicide Ideation (SSI) to assess the characteristics and severity of SI. Results: There was a statistically significant correlation between the presence of MiL subscale and the SSI. These 2 scales had a negative and statistically highly significant correlation (R=–.667; P<.001). The results also showed a negative and statistically highly significant correlation between the score of the search for MiL and the SSI (R=–.456; P<.001). The results thus pointed to the presence of MiL as a potential protective factor against the severity of SI, while the search for MiL is also a possible resiliency factor, although to a lesser extent. The profile low presence–low search grouped the vast majority (47%) of the patients; in these patients, the mean SSI score was 14.36 (SD 5.86), much higher compared with that of the other subgroups. Conclusions: This study’s results point to MiL as a concept of interest regarding devising psychotherapeutic interventions for chronic pain patients in order to reduce the suicidal risk and more accurately determine patients’ suffering. %M 35699974 %R 10.2196/35194 %U https://formative.jmir.org/2022/6/e35194 %U https://doi.org/10.2196/35194 %U http://www.ncbi.nlm.nih.gov/pubmed/35699974 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 5 %P e34262 %T Demonstration and Acceptability of a Safer Conception Intervention for Men With HIV in South Africa: Pilot Cohort Study %A Matthews,Lynn T %A Psaros,Christina %A Mathenjwa,Mxolisi %A Mosery,Nzwakie %A Greener,Letitia Rambally %A Khidir,Hazar %A Hovey,Jacquelyn R %A Pratt,Madeline C %A Harrison,Abigail %A Bennett,Kara %A Bangsberg,David R %A Smit,Jennifer A %A Safren,Steven A %+ Division of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham, 212 Ziegler Research Building, 1720 2nd Ave South, Birmingham, AL, 35294, United States, 1 205 934 8148, lynnmatthews@uabmc.edu %K men with HIV %K HIV prevention %K safer conception %K U=U %K treatment as prevention %K reproductive health %K South Africa %D 2022 %7 4.5.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Many men with HIV (MWH) want to have children. HIV viral suppression minimizes sexual HIV transmission risks while allowing for conception and optimization of the health of men, their partners, and their infants. Objective: This study developed and evaluated the feasibility and acceptability of an intervention to promote serostatus disclosure, antiretroviral therapy (ART) uptake and adherence, and viral suppression among MWH who want to have children in South Africa. Methods: We developed a safer conception intervention (Sinikithemba Kwabesilisa or We give hope to men) to promote viral suppression via ART uptake and adherence, HIV serostatus disclosure, and other safer conception strategies for MWH in South Africa. Through 3 counseling and 2 booster sessions over 12 weeks, we offered education on safer conception strategies and aided participants in developing a safer conception plan. We recruited MWH (HIV diagnosis known for >1 month), not yet accessing ART or accessing ART for <3 months, in a stable partnership with an HIV-negative or unknown-serostatus woman, and wanting to have a child in the following year. We conducted an open pilot study to evaluate acceptability based on patient participation and exit interviews and feasibility based on recruitment and retention. In-depth exit interviews were conducted with men to explore intervention acceptability. Questionnaires collected at baseline and exit assessed disclosure outcomes; CD4 and HIV-RNA data were used to evaluate preliminary impacts on clinical outcomes of interest. Results: Among 31 eligible men, 16 (52%) enrolled in the study with a median age of 29 (range 27-44) years and a median time-since-diagnosis of 7 months (range 1 month to 9 years). All identified as Black South African, with 56% (9/16) reporting secondary school completion and 44% (7/16) reporting full-time employment. Approximately 44% (7/16) of participants reported an HIV-negative (vs unknown-serostatus) partner. Approximately 88% (14/16) of men completed the 3 primary counseling sessions. In 11 exit interviews, men reported personal satisfaction with session content and structure while also suggesting that they would refer their peers to the program. They also described the perceived effectiveness of the intervention and self-efficacy to benefit. Although significance testing was not conducted, 81% (13/16) of men were taking ART at the exit, and 100% (13/13) of those on ART were virally suppressed at 12 weeks. Of the 16 men, 12 (75%) reported disclosure to pregnancy partners. Conclusions: These preliminary data suggest that safer conception care is acceptable to men and has the potential to reduce HIV incidence among women and their children while supporting men’s health. Approximately half of the men who met the screening eligibility criteria were enrolled. Accordingly, refinement to optimize uptake is needed. Providing safer conception care and peer support at the community level may help reach men. Trial Registration: ClinicalTrials.gov NCT03818984; https://clinicaltrials.gov/ct2/show/NCT03818984 International Registered Report Identifier (IRRID): RR2-10.1007/s10461-017-1719-4 %M 35507406 %R 10.2196/34262 %U https://formative.jmir.org/2022/5/e34262 %U https://doi.org/10.2196/34262 %U http://www.ncbi.nlm.nih.gov/pubmed/35507406 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e32625 %T Adherence to a Multidisciplinary Lifestyle Program for Patients With Atrial Fibrillation and Obesity: Feasibility Study %A Tenbult,Nicole %A Kraal,Jos %A Brouwers,Rutger %A Spee,Ruud %A Eijsbouts,Sabine %A Kemps,Hareld %+ Telemedicine and Rehabilitation in Chronic Disease, Flow, Center for Prevention, Máxima MC, Dominee Theodor Fliednerstraat 1, Veldhoven/Eindhoven, 5631 BM, Netherlands, 31 040 8888220, nicole.van.limpt@mmc.nl %K cardiac rehabilitation %K atrial fibrillation %K obesity %K participation %K completion %K adherence %K lifestyle %D 2022 %7 29.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Atrial fibrillation is commonly associated with obesity. Observational studies have shown that weight loss is associated with improved prognosis and a decrease in atrial fibrillation frequency and severity. However, despite these benefits, nonadherence to lifestyle programs is common. Objective: In this study, we evaluated adherence to and feasibility of a multidisciplinary lifestyle program focusing on behavior change in patients with atrial fibrillation and obesity. Methods: Patients with atrial fibrillation and obesity participated in a 1-year goal-oriented cardiac rehabilitation program. After baseline assessment, the first 3 months included a cardiac rehabilitation intervention with 4 fixed modules: lifestyle counseling (with an advanced nurse practitioner), exercise training, dietary consultation, and psychosocial therapy; relaxation sessions were an additional optional treatment module. An advanced nurse practitioner monitored the personal lifestyle of each individual patient, with assessments and consultations at 3 months (ie, immediately after the intervention) and at the end of the year (ie, 9 months after the intervention). At each timepoint, level of physical activity, personal goals and progress, atrial fibrillation symptoms and frequency (Atrial Fibrillation Severity Scale), psychosocial stress (Generalized Anxiety Disorder–7), and depression (Patient Health Questionnaire–9) were assessed. The primary endpoints were adherence (defined as the number of visits attended as percentage of the number of planned visits) and completion rates of the cardiac rehabilitation intervention (defined as performing at least of 80% of the prescribed sessions). In addition, we performed an exploratory analysis of effects of the cardiac rehabilitation program on weight and atrial fibrillation symptom frequency and severity. Results: Patients with atrial fibrillation and obesity (male: n=8; female: n=2; age: mean 57.2 years, SD 9.0; baseline weight: mean 107.2 kg, SD 11.8; baseline BMI: mean 32.4 kg/m2, SD 3.5) were recruited. Of the 10 participants, 8 participants completed the 3-month cardiac rehabilitation intervention, and 2 participants did not complete the cardiac rehabilitation intervention (both because of personal issues). Adherence to the fixed treatment modules was 95% (mean 3.8 sessions attended out of mean 4 planned) for lifestyle counseling, 86% (mean 15.2 sessions attended out of mean 17.6 planned) for physiotherapy sessions, 88% (mean 3.7 sessions attended out of mean 4.1 planned) for dietician consultations, and 60% (mean 0.6 sessions attended out of mean 1.0 planned) for psychosocial therapy; 70% of participants (7/10) were referred to the optional relaxation sessions, for which adherence was 86% (mean 2 sessions attended out of mean 2.4 planned). The frequency of atrial fibrillation symptoms was reduced immediately after the intervention (before: mean 35.6, SD 3.8; after: mean 31.2, SD 3.3), and this was sustained at 12 months (mean 24.8, SD 3.2). The severity of atrial fibrillation complaints immediately after the intervention (mean 20.0, SD 3.7) and at 12 months (mean 9.3, SD 3.6) were comparable to that at baseline (mean 16.6, SD 3.3). Conclusions: A 1-year multidisciplinary lifestyle program for obese patients with atrial fibrillation was found to be feasible, with high adherence and completion rates. Exploratory analysis revealed a sustained reduction in atrial fibrillation symptoms; however, these results remain to be confirmed in large-scale studies. %M 35486435 %R 10.2196/32625 %U https://formative.jmir.org/2022/4/e32625 %U https://doi.org/10.2196/32625 %U http://www.ncbi.nlm.nih.gov/pubmed/35486435 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e34394 %T Workplace Reintegration Facilitator Training Program for Mental Health Literacy and Workplace Attitudes of Public Safety Personnel: Pre-Post Pilot Cohort Study %A Jones,Chelsea %A Smith-MacDonald,Lorraine %A Pike,Ashley %A Bright,Katherine %A Bremault-Phillips,Suzette %+ Heroes in Mind, Advocacy and Research Consortium, Faculty of Rehabilitation Medicine, University of Alberta, 1-94 Corbett Hall, 8205-114 Street, Edmonton, AB, T6G 2G4, Canada, 1 780 492 0404, cweiman@ualberta.ca %K public safety personnel %K mental health %K return to work %K reintegration %K first responders %D 2022 %7 26.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Public safety personnel (PSP) impacted by operational stress injuries can find themselves needing both time off work and support reintegrating back into the workforce. Work reintegration programs have been introduced in PSP organizations to support those who aim to return to work. One such peer-led workplace reintegration program (RP) was created in 2009 by members of the Edmonton Police Service (EPS). The primary goal of the EPSRP is to assist PSP in returning to work as soon as possible following a critical incident, illness, or injury while diminishing the potential for long-term psychological injury. The EPSRP is delivered by peers through 3 interrelated components: (1) the Reintegration Program Facilitator Training (RPFT) Program; (2) a short-term Critical Incident RP; and (3) a long-term RP. There is a dire need for research that incorporates strong study designs to the determine long-term effectiveness of the program on increasing workplace reintegration, improving mental health knowledge, and creating culture change within PSP organizations. Simultaneously, the efficacy, effectiveness, and fidelity of the RPFT in providing the tools, mental health knowledge, and skills the RP peer facilitators will need for the RP must be evaluated. Objective: The purpose of this quasi-experimental pre-post pilot cohort study is to evaluate the effectiveness of the EPSRPFT course on influencing mental health knowledge and attitudes of RPFT attendees who will be future RP peer facilitators. Methods: This pre-post cohort study collected data via 2 questionnaires from RPFT participants (N=60) which included the Mental Health Knowledge Survey (MAKS) and the Open Minds Survey of Workplace Attitudes (OMSWA). Descriptive, parametric (sample t tests), and nonparametric (Wilcoxon signed rank tests) statistics were used to compare the pre- and post-RPFT results and to analyze results by gender and profession. Results: Statistically significant changes were observed in pre-post questionnaire scores in the domains of mental health attitudes and knowledge. Conclusions: Although results are explorative, the RPFT may facilitate positive changes in workplace mental health attitudes and knowledge among PSP. It is hoped these findings will contribute to a broader evidence base that can inform changes to the program, practices, and policies, and inform decision-making regarding the EPSRP. %M 35471413 %R 10.2196/34394 %U https://formative.jmir.org/2022/4/e34394 %U https://doi.org/10.2196/34394 %U http://www.ncbi.nlm.nih.gov/pubmed/35471413 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 2 %P e26130 %T A Couples-Based Intervention (Ghya Bharari Ekatra) for the Primary Prevention of Intimate Partner Violence in India: Pilot Feasibility and Acceptability Study %A Kalokhe,Ameeta Shivdas %A Iyer,Sandhya %A Gadhe,Keshav %A Katendra,Tuman %A Kolhe,Ambika %A Rahane,Girish %A Stephenson,Rob %A Sahay,Seema %+ Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, 5003 CNR Building, 1518 Clifton Road, Atlanta, GA, 30322, United States, 1 404 712 1924, akalokh@emory.edu %K intimate partner violence %K prevention %K pilot study %K gender-based violence %K domestic violence %K violence %K India %K intervention %K prevalence %K mental health %K acceptance %K safety %K feasibility %K efficacy %D 2021 %7 1.2.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: The high global prevalence of intimate partner violence (IPV) and its association with poor physical and mental health underscore the need for effective primary prevention. We previously developed Ghya Bharari Ekatra (GBE), a couples-based primary prevention intervention for IPV among newly married couples residing in slum communities in Pune, India. Objective: Through this pilot study, we aimed to explore the acceptance, safety, feasibility, and preliminary efficacy of GBE. Methods: Between January and May 2018, we enrolled and assigned 20 couples to receive GBE plus information on IPV support services and 20 control couples to receive information on IPV support services alone. The GBE intervention was delivered over 6 weekly sessions to groups of 3 to 5 couples by lay peer educators in the communities in which the participants resided. Intervention components addressed relationship quality, resilience, communication and conflict negotiation, self-esteem, sexual communication and sexual health knowledge, and norms around IPV. Outcome evaluation included exit interviews with participants and peers to examine acceptance and feasibility challenges and baseline and 3-month follow-up interviews to examine change in IPV reporting and mental health (by women) and alcohol misuse (by men). The process evaluation examined dose delivered, dose received, fidelity, recruitment, participation rate, and context. Results: Half (40/83) of the eligible couples approached agreed to participate in the GBE intervention. Retention rates were high (17/20, 85% across all 6 sessions), feedback from exit interviews suggested the content and delivery methods were very well received, and the community was highly supportive of the intervention. The principal feasibility challenge involved recruiting men with the lowest income who were dependent on daily wages. No safety concerns were reported by female participants over the course of the intervention or at the 3-month follow-up. There were no reported physical or sexual IPV events in either group, but there were fewer incidents of psychological abuse in GBE participants (3/17, 18%) versus control participants (4/16, 25%) at 3-month follow-up. There was also significant improvement in the overall mental health of female intervention participants and declines in the control participants (change in mean General Health Questionnaire-12 score: –0.13 in intervention vs 0.13 in controls; P=.10). Conclusions: GBE has high acceptance, feasibility, and preliminary efficacy in preventing IPV and improving mental health among women. Next steps include refining the intervention content based on pilot findings and examining intervention efficacy through a large-scale randomized trial with longer follow-up. Trial Registration: ClinicalTrials.gov NCT03332134; https://clinicaltrials.gov/ct2/show/NCT03332134. Clinical Trials Registry of India CTRI/2018/01/011596; http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=21443 International Registered Report Identifier (IRRID): RR2-10.2196/11533 %M 33459278 %R 10.2196/26130 %U https://formative.jmir.org/2021/2/e26130 %U https://doi.org/10.2196/26130 %U http://www.ncbi.nlm.nih.gov/pubmed/33459278 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 12 %P e19270 %T Iterative Adaptation of a Tuberculosis Digital Medication Adherence Technology to Meet User Needs: Qualitative Study of Patients and Health Care Providers Using Human-Centered Design Methods %A Patel,Devika %A Berger,Christopher Allen %A Kityamuwesi,Alex %A Ggita,Joseph %A Kunihira Tinka,Lynn %A Turimumahoro,Patricia %A Feler,Joshua %A Chehab,Lara %A Chen,Amy Z %A Gupta,Nakull %A Turyahabwe,Stavia %A Katamba,Achilles %A Cattamanchi,Adithya %A Sammann,Amanda %+ Division of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California, San Francisco, 1001 Potrero Avenue, San Francisco, CA, 94110, United States, 1 4152064679, Christopher.berger@ucsf.edu %K human-centered design %K tuberculosis %K digital adherence technology %K digital health %K adherence %K medication %K treatment %K outcome %K lung %K respiratory %K infectious disease %D 2020 %7 8.12.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital adherence technologies have been widely promoted as a means to improve tuberculosis medication adherence. However, uptake of these technologies has been suboptimal by both patients and health workers. Not surprisingly, studies have not demonstrated significant improvement in treatment outcomes. Objective: This study aimed to optimize a well-known digital adherence technology, 99DOTS, for end user needs in Uganda. We describe the findings of the ideation phase of the human-centered design methodology to adapt 99DOTS according to a set of design principles identified in the previous inspiration phase. Methods: 99DOTS is a low-cost digital adherence technology wherein tuberculosis medication blister packs are encased within an envelope that reveals toll-free numbers that patients can call to report dosing. We identified 2 key areas for design and testing: (1) the envelope, including the form factor, content, and depiction of the order of pill taking; and (2) the patient call-in experience. We conducted 5 brainstorming sessions with all relevant stakeholders to generate a suite of potential prototype concepts. Senior investigators identified concepts to further develop based on feasibility and consistency with the predetermined design principles. Prototypes were revised with feedback from the entire team. The envelope and call-in experience prototypes were tested and iteratively revised through focus groups with health workers (n=52) and interviews with patients (n=7). We collected and analyzed qualitative feedback to inform each subsequent iteration. Results: The 5 brainstorming sessions produced 127 unique ideas that we clustered into 6 themes: rewards, customization, education, logistics, wording and imagery, and treatment countdown. We developed 16 envelope prototypes, 12 icons, and 28 audio messages for prototype testing. In the final design, we altered the pill packaging envelope by adding a front flap to conceal the pills and reduce potential stigma associated with tuberculosis. The flap was adorned with either a blank calendar or map of Uganda. The inside cover contained a personalized message from a local health worker including contact information, pictorial pill-taking instructions, and a choice of stickers to tailor education to the patient and phase of treatment. Pill-taking order was indicated with colors, chevron arrows, and small mobile phone icons. Last, the call-in experience when patients report dosing was changed to a rotating series of audio messages centered on the themes of prevention, encouragement, and reassurance that tuberculosis is curable. Conclusions: We demonstrated the use of human-centered design as a promising tool to drive the adaptation of digital adherence technologies to better address the needs and motivations of end users. The next phase of research, known as the implementation phase in the human-centered design methodology, will investigate whether the adapted 99DOTS platform results in higher levels of engagement from patients and health workers, and ultimately improves tuberculosis treatment outcomes. %M 33289494 %R 10.2196/19270 %U https://formative.jmir.org/2020/12/e19270 %U https://doi.org/10.2196/19270 %U http://www.ncbi.nlm.nih.gov/pubmed/33289494 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 12 %P e20871 %T Citizen Responses to Government Restrictions in Switzerland During the COVID-19 Pandemic: Cross-Sectional Survey %A Selby,Kevin %A Durand,Marie-Anne %A Gouveia,Alexandre %A Bosisio,Francesca %A Barazzetti,Gaia %A Hostettler,Maxime %A D'Acremont,Valérie %A Kaufmann,Alain %A von Plessen,Christian %+ Center for Primary Care and Public Health (Unisanté), University of Lausanne, Rue de Bugnon 44, Lausanne, 1011, Switzerland, 41 0798940957, kevin.selby@unisante.ch %K COVID-19 %K coronavirus %K Switzerland %K mitigation strategies %K citizen knowledge %D 2020 %7 3.12.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: The success of government-recommended mitigation measures during the COVID-19 pandemic depends largely on information uptake and implementation by individual citizens. Objective: Our aim was to assess citizens’ knowledge and perceptions about COVID-19 recommendations in the Canton of Vaud, Switzerland. Methods: A cross-sectional electronic survey with open and closed questions was disseminated by community-based partners prior to the relaxation of government restrictions. Outcomes included citizen knowledge (9-question measure) and worry about the virus, perception of government measures, and recommendations for improvements. Comparisons used linear regression, controlling for age, sex, education, and health literacy. Free-text answers were analyzed thematically. Results: Of 807 people who accessed the survey, 684 (85%) completed all questions and 479 (60%) gave free-text recommendations. Overall, 75% were female, the mean age was 48 years, and 93% had high health literacy. Knowledge scores were high, with a median score of 8 out of 9. Mean levels of worry about the COVID-19 pandemic were higher in women than men (55/100 versus 44/100, P<.001), and in respondents with lower health literacy (57/100 versus 52/100, P=.03). Self-reported adherence to recommendations was high (85%) and increased with age and worry (both P<.001). Respondents rated their own adherence higher than others (85% versus 61%, P<.001). Moreover, 34% of respondents reported having self-quarantined; this rose to 52% for those aged ≥75 years. Those who had self-quarantined reported higher levels of fear. Nearly half (49%) of respondents felt the government response had been adequate, though younger age and higher levels of worry were associated with considering the response to be insufficient (both P<.001). Analysis of open-text answers revealed 4 major themes: access to and use of masks, gloves, and hand sanitizer; government messaging; lockdown and lockdown exit plan communication; and testing for COVID-19. Conclusions: Knowledge, adherence, and satisfaction regarding government recommendations and response were high in this sample, but many desired greater access to personal protective equipment. Those with lower health literacy and those who have been in self-isolation reported greater concerns about the pandemic. %M 33156809 %R 10.2196/20871 %U https://formative.jmir.org/2020/12/e20871 %U https://doi.org/10.2196/20871 %U http://www.ncbi.nlm.nih.gov/pubmed/33156809 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 10 %P e22043 %T Mental Health During the COVID-19 Pandemic in the United States: Online Survey %A Jewell,Jennifer S %A Farewell,Charlotte V %A Welton-Mitchell,Courtney %A Lee-Winn,Angela %A Walls,Jessica %A Leiferman,Jenn A %+ Colorado School of Public Health, Building 500, 13001 E 17th Place, Aurora, CO , United States, 1 303 519 6620, jennifer.jewell@cuanschutz.edu %K COVID-19 %K mental health %K pandemic %K depression %K anxiety %K well-being %K stress %D 2020 %7 23.10.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: The COVID-19 pandemic has had numerous worldwide effects. In the United States, there have been 8.3 million cases and nearly 222,000 deaths as of October 21, 2020. Based on previous studies of mental health during outbreaks, the mental health of the population will be negatively affected in the aftermath of this pandemic. The long-term nature of this pandemic may lead to unforeseen mental health outcomes and/or unexpected relationships between demographic factors and mental health outcomes. Objective: This research focused on assessing the mental health status of adults in the United States during the early weeks of an unfolding pandemic. Methods: Data was collected from English-speaking adults from early April to early June 2020 using an online survey. The final convenience sample included 1083 US residents. The 71-item survey consisted of demographic questions, mental health and well-being measures, a coping mechanisms checklist, and questions about COVID-19–specific concerns. Hierarchical multivariable logistic regression was used to explore associations among demographic variables and mental health outcomes. Hierarchical linear regression was conducted to examine associations among demographic variables, COVID-19–specific concerns, and mental health and well-being outcomes. Results: Approximately 50% (536/1076) of the US sample was aged ≥45 years. Most of the sample was White (1013/1054, 96%), non-Hispanic (985/1058, 93%), and female (884/1073, 82%). Participants reported high rates of depression (295/1034, 29%), anxiety (342/1007, 34%), and stress (773/1058, 73%). Older individuals were less likely to report depressive symptomology (OR 0.78, P<.001) and anxiety symptomology (OR 0.72, P<.001); in addition, they had lower stress scores (–0.15 points, SE 0.01, P<.001) and increased well-being scores (1.86 points, SE 0.22, P<.001). Individuals who were no longer working due to COVID-19 were 2.25 times more likely to report symptoms of depression (P=.02), had a 0.51-point increase in stress (SE 0.17, P=.02), and a 3.9-point decrease in well-being scores (SE 1.49, P=.009) compared to individuals who were working remotely before and after COVID-19. Individuals who had partial or no insurance coverage were 2-3 times more likely to report depressive symptomology compared to individuals with full coverage (P=.02 and P=.01, respectively). Individuals who were on Medicare/Medicaid and individuals with no coverage were 1.97 and 4.48 times more likely to report moderate or severe anxiety, respectively (P=.03 and P=.01, respectively). Financial and food access concerns were significantly and positively related to depression, anxiety, and stress (all P<.05), and significantly negatively related to well-being (both P<.001). Economy, illness, and death concerns were significantly positively related to overall stress scores (all P<.05). Conclusions: Our findings suggest that many US residents are experiencing high stress, depressive, and anxiety symptomatology, especially those who are underinsured, uninsured, or unemployed. Longitudinal investigation of these variables is recommended. Health practitioners may provide opportunities to allay concerns or offer coping techniques to individuals in need of mental health care. These messages should be shared in person and through practice websites and social media. %M 33006939 %R 10.2196/22043 %U http://formative.jmir.org/2020/10/e22043/ %U https://doi.org/10.2196/22043 %U http://www.ncbi.nlm.nih.gov/pubmed/33006939 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 9 %P e17835 %T Evaluation of an Occupational Exercise Training Program for Firefighters: Mixed Methods Pilot Study %A Leary,Miriam %A Thomas,James %A Hayes,Ryan %A Sherlock,Lori %+ Division of Exercise Physiology, Department of Human Performance and Applied Exercise Science, West Virginia University, 8324 HSC South, PO Box 9227, Morgantown, WV, 26505, United States, 1 3045811755, miriam.leary@hsc.wvu.edu %K firefighters %K exercise %K mixed methods %K qualitative %K clinical %K performance %D 2020 %7 21.9.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: Occupational exercise training programs can improve overall health and fitness in firefighters, but evidence beyond clinical and performance outcomes is needed before fire departments invest in and successfully adopt health promotion programs. Objective: This mixed methods pilot study sought to pair clinical and performance outcomes with participants’ qualitative feedback (eg, participants’ enjoyment, lifestyle behavior changes, and team structure) with the goal of informing recommendations for future programs. Methods: Professional firefighters participated in a 14-week occupational exercise training program with assessments conducted pre- and posttraining. Clinical outcomes included weight, BMI, body fat percentage, resting heart rate, systolic blood pressure, and diastolic blood pressure. Performance outcomes included the sharpened Romberg balance test, 1-repetition maximum leg press and bench press, graded exercise test (estimated VO2max), knee range of motion, shoulder flexibility, and hamstring flexibility. Self-administered surveys (Short Form-36, International Physical Activity Questionnaire, Barriers Self-Efficacy Scale, and Barriers to Being Active Quiz) were completed. In 3 private focus groups of 3 to 4 participants, firefighters' experiences in the training program and their health behaviors were explored. Results: Male firefighters (n=14; age: mean 36.4, SD 2.6 years) completed 20 training sessions. There were no significant changes to weight (P=.20), BMI (P=.15), body fat percentage (P=.16), systolic blood pressure (P=.12), estimated VO2max (P=.34), balance (P=.24), knee range of motion (left: P=.35; right: P=.31), or hamstring flexibility (P=.14). There was a significant decrease in diastolic blood pressure (P=.04) and significant increases in shoulder flexibility (P<.001) and leg press 1-repetition maximum volume (P=.04). Participants reported improvements in overall health, endurance, flexibility, and mood as well as improvements to team environment and health behaviors around the station; however, there was a decline in overcoming barriers to physical activity. Conclusions: A 14-week program of exercise training in firefighters elicited improvements in clinical, performance, and self-reported physical activity outcomes. This occupational exercise training program for firefighters increased time spent exercising, improved team building, and led to physical and mental health benefits. Results from this pilot study set a broad, informed, and meaningful foundation for future efforts to increase firefighter participation in occupational fitness programs. %M 32955453 %R 10.2196/17835 %U http://formative.jmir.org/2020/9/e17835/ %U https://doi.org/10.2196/17835 %U http://www.ncbi.nlm.nih.gov/pubmed/32955453 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 9 %P e20606 %T Knowledge and Psychological Stress Related to COVID-19 Among Nursing Staff in a Hospital in China: Cross-Sectional Survey Study %A Huang,Huaping %A Zhao,Wen-Jun %A Li,Gui-Rong %+ Department of Nursing, Mianyang Central Hospital, No.12, Changjia Alley, Jingzhogn Street, Fucheng District, Mianyang, 621000, China, 86 0816 2239671, 384895848@qq.com %K COVID-19 %K nursing staff %K knowledge %K psychological stress %D 2020 %7 18.9.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: Since December 2019, coronavirus disease (COVID-19) has been rapidly spreading worldwide. Nurses play a key role in fighting this disease and are at risk of COVID-19 infection. Therefore, there is an urgent need to assess the mental health condition of nurses and establish appropriate interventions to reduce the negative psychiatric outcomes of the pandemic. Objective: The objectives of this study were to evaluate the knowledge and psychological stress related to COVID-19 among nursing staff and to provide evidence of the need for targeted training and psychological intervention. Methods: This cross-sectional web-based survey study was performed in a class 3 grade A general hospital in a southwest province of China from March 1 to March 15, 2020. A self-designed questionnaire with questions about COVID-19–related prevention and control knowledge and the Triage Assessment Form (TAF) were used to assess nursing staff’s knowledge of COVID-19 and their degree of psychological stress, respectively. SPSS 23.0 was applied for statistical analysis of the collected data. Results: A total of 979 nurses completed the questionnaire. The results showed that the nursing staff provided the fewest correct answers to questions about continuous viral nucleic acid testing specifications (379/979 correct answers, 38.7%), isolation/discharge criteria (539/979 correct answers, 55.1%), and management measures for patients with suspected symptoms (713/979 correct answers, 72.8%). The median total score of the TAF was 7.0 (IQR 5.0-12.0), and there were statistically significant differences in scores between different nursing roles, years of work experience, and hospital departments (P<.05). Conclusions: This study indicated that nursing staff have insufficient knowledge about COVID-19. Meanwhile, although the psychological damage to nurses during the pandemic was found to be low, nurse managers must continue to monitor the mental health of nursing staff and perform timely interventions. %M 32640419 %R 10.2196/20606 %U https://formative.jmir.org/2020/9/e20606 %U https://doi.org/10.2196/20606 %U http://www.ncbi.nlm.nih.gov/pubmed/32640419 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 8 %P e18223 %T Shared Decision Making and Patient-Centered Care in Israel, Jordan, and the United States: Exploratory and Comparative Survey Study of Physician Perceptions %A Zisman-Ilani,Yaara %A Obeidat,Rana %A Fang,Lauren %A Hsieh,Sarah %A Berger,Zackary %+ Department of Social and Behavioral Sciences, College of Public Health, Temple University, 1700 North Broad St, Philadelphia, PA, 19122, United States, 1 215 204 5618, yaara@temple.edu %K shared decision making %K patient-centered care %K Middle East %K physicians %K perceptions %D 2020 %7 3.8.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: Shared decision making (SDM) is a health communication model that evolved in Europe and North America and largely reflects the values and medical practices dominant in these areas. Objective: This study aims to understand the beliefs, perceptions, and practices related to SDM and patient-centered care (PCC) of physicians in Israel, Jordan, and the United States. Methods: A hypothesis-generating comparative survey study was administered to physicians from Israel, Jordan, and the United States. Results: A total of 36 surveys were collected via snowball sampling (Jordan: n=15; United States: n=12; Israel: n=9). SDM was perceived as a way to inform patients and allow them to participate in their care. Barriers to implementing SDM varied based on place of origin; physicians in the United States mentioned limited time, physicians in Jordan reported that a lack of patient education limits SDM practices, and physicians in Israel reported lack of communication training. Most US physicians defined PCC as a practice for prioritizing patient preferences, whereas both Jordanian and Israeli physicians defined PCC as a holistic approach to care and to prioritizing patient needs. Barriers to implementing PCC, as seen by US physicians, were mostly centered on limited appointment time and insurance coverage. In Jordan and Israel, staff shortage and a lack of resources in the system were seen as major barriers to PCC implementation. Conclusions: The study adds to the limited, yet important, literature on SDM and PCC in areas of the world outside the United States, Canada, Australia, and Western Europe. The study suggests that perceptions of PCC might widely differ among these regions, whereas concepts of SDM might be shared. Future work should clarify these differences. %M 32744509 %R 10.2196/18223 %U https://formative.jmir.org/2020/8/e18223 %U https://doi.org/10.2196/18223 %U http://www.ncbi.nlm.nih.gov/pubmed/32744509 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 6 %P e18703 %T A Mind-Body Physical Activity Program for Chronic Pain With or Without a Digital Monitoring Device: Proof-of-Concept Feasibility Randomized Controlled Trial %A Greenberg,Jonathan %A Popok,Paula J %A Lin,Ann %A Kulich,Ronald J %A James,Peter %A Macklin,Eric A %A Millstein,Rachel A %A Edwards,Robert R %A Vranceanu,Ana-Maria %+ Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, , United States, 1 617 724 4977, avranceanu@mgh.harvard.edu %K chronic pain %K meditation %K walking %K feasibility studies %K actigraphy %D 2020 %7 8.6.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: Chronic pain is associated with poor physical and emotional functioning. Nonpharmacological interventions can help, but improvements are small and not sustained. Previous clinical trials do not follow recommendations to comprehensively target objectively measured and performance-based physical function in addition to self-reported physical function. Objective: This study aimed to establish feasibility benchmarks and explore improvements in physical (self-reported, performance based, and objectively measured) and emotional function, pain outcomes, and coping through a pilot randomized controlled trial of a mind-body physical activity program (GetActive) with and without a digital monitoring device (GetActive-Fitbit), which were iteratively refined through mixed methods. Methods: Patients with chronic pain were randomized to the GetActive (n=41) or GetActive-Fitbit (n=41) programs, which combine relaxation, cognitive behavioral, and physical restoration skills and were delivered in person. They completed in-person assessments before and after the intervention. Performance-based function was assessed with the 6-min walk test, and step count was measured with an ActiGraph. Results: Feasibility benchmarks (eg, recruitment, acceptability, credibility, therapist adherence, adherence to practice at home, ActiGraph wear, and client satisfaction) were good to excellent and similar in both programs. Within each program, we observed improvement in the 6-min walk test (mean increase=+41 m, SD 41.15; P<.001; effect size of 0.99 SD units for the GetActive group and mean increase=+50 m, SD 58.63; P<.001; effect size of 0.85 SD units for the GetActive-Fitbit group) and self-reported physical function (P=.001; effect size of 0.62 SD units for the GetActive group and P=.02; effect size of 0.38 SD units for the GetActive-Fitbit group). The mean step count increased only among sedentary patients (mean increase=+874 steps for the GetActive group and +867 steps for the GetActive-Fitbit group). Emotional function, pain intensity, pain coping, and mindfulness also improved in both groups. Participants rated themselves as much improved at the end of the program, and those in the GetActive-Fitbit group noted that Fitbit greatly helped with increasing their activity. Conclusions: These preliminary findings support a fully powered efficacy trial of the two programs against an education control group. We present a model for successfully using the Initiative on the Methods, Measurement, and Pain Assessment in Clinical Trials criteria for a comprehensive assessment of physical function and following evidence-based models to maximize feasibility before formal efficacy testing. Trial Registration: ClinicalTrial.gov NCT03412916; https://clinicaltrials.gov/ct2/show/NCT03412916 %M 32348281 %R 10.2196/18703 %U https://formative.jmir.org/2020/6/e18703 %U https://doi.org/10.2196/18703 %U http://www.ncbi.nlm.nih.gov/pubmed/32348281 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 4 %P e14747 %T Interventions to Increase the Reachability of Migrants in Germany With Health Interview Surveys: Mixed-Mode Feasibility Study %A Zeisler,Marie-Luise %A Bilgic,Leman %A Schumann,Maria %A Wengler,Annelene %A Lemcke,Johannes %A Gößwald,Antje %A Lampert,Thomas %A Santos-Hövener,Claudia %A Schmich,Patrick %+ Robert Koch Institute, Berlin, Germany, 49 30 18754 3694, ZeislerM@rki.de %K transients and migrants %K surveys and questionnaires %K cross-sectional studies %K feasibility studies %K multilingualism and health monitoring %D 2020 %7 15.4.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: Germany is a popular destination for immigrants, and migration has increased in recent years. It is therefore important to collect reliable data on migrants’ health. The Robert Koch Institute, Berlin, Germany, has launched the Improving Health Monitoring in Migrant Populations (IMIRA) project to sustainably integrate migrant populations into health monitoring in Germany. Objective: One of IMIRA’s objectives is to implement a feasibility study (the IMIRA survey) that focuses on testing various interventions to increase the reachability of migrants with health interview surveys. Possible causes of nonresponse should be identified so as to increase participation in future surveys. Methods: The survey target populations were Turkish, Polish, Romanian, Syrian, and Croatian migrants, who represent the biggest migrant groups living in Germany. We used probability sampling, using data from the registration offices in 2 states (Berlin and Brandenburg); we randomly selected 9068 persons by nationality in 7 sample points. We applied age (3 categories: 18-44, 45-64, and ≥65 years) and sex strata. Modes and methods used to test their usability were culturally sensitive materials, online questionnaires, telephone interviews, personal contact, and personal interviews, using multilingual materials and interviewers. To evaluate the effectiveness of the interventions, we used an intervention group (group A) and a control group (group B). There were also focus groups with the interviewers to get more information about the participants’ motivation. We used the European Health Interview Survey, with additional instruments on religious affiliation, experience of discrimination, and subjective social status. We evaluated results according to their final contact result (disposition code). Results: We collected data from January to May 2018 in Berlin and Brandenburg, Germany. The survey had an overall response rate of 15.88% (1190/7494). However, final disposition codes varied greatly with regard to citizenship. In addition to the quantitative results, interviewers reported in the focus groups a “feeling of connectedness” to the participants due to the multilingual interventions. The interviewers were particularly positive about the home visits, because “if you are standing at the front door, you will be let in for sure.” Conclusions: The IMIRA survey appraised the usability of mixed-mode or mixed-method approaches among migrant groups with a probability sample in 2 German states. When conducting the survey, we were confronted with issues regarding the translation of the questionnaire, as well as the validity of some instruments in the survey languages. A major result was that personal face-to-face contact was the most effective intervention to recruit our participants. We will implement the findings in the upcoming health monitoring study at the Robert Koch Institute. %M 32305950 %R 10.2196/14747 %U https://formative.jmir.org/2020/4/e14747 %U https://doi.org/10.2196/14747 %U http://www.ncbi.nlm.nih.gov/pubmed/32305950