TY - JOUR AU - Militello, Lisa AU - Sezgin, Emre AU - Huang, Yungui AU - Lin, Simon PY - 2021/3/1 TI - Delivering Perinatal Health Information via a Voice Interactive App (SMILE): Mixed Methods Feasibility Study JO - JMIR Form Res SP - e18240 VL - 5 IS - 3 KW - perinatal care KW - infant mortality KW - health education KW - mobile health KW - feasibility studies KW - family KW - mobile phone KW - webcasts as topic KW - user-computer interface N2 - Background: Perinatal health care is critically important for maternal health outcomes in infants. The United States fares considerably worse than comparable countries for maternal and infant mortality rates. As such, alternative models of care or engagement are warranted. Ubiquitous digital devices and increased use of digital health tools have the potential to extend the reach to women and infants in their everyday lives and make a positive impact on their health outcomes. As voice technology becomes more mainstream, research is prudent to establish evidence-based practice on how to best leverage voice technology to promote maternal-infant health. Objective: The aim of this study is to assess the feasibility of using voice technology to support perinatal health and infant care practices. Methods: Perinatal women were recruited from a large Midwest Children?s Hospital via hospital email announcements and word of mouth. Owing to the technical aspects of the intervention, participants were required to speak English and use an iPhone. Demographics, patterns of technology use, and technology use specific to perinatal health or self-care practices were assessed at baseline. Next, participants were onboarded and asked to use the intervention, Self-Management Intervention?Life Essentials (SMILE), over the course of 2 weeks. SMILE provided users with perinatal health content delivered through mini podcasts (ranging from 3 to 8 minutes in duration). After each podcast, SMILE prompted users to provide immediate verbal feedback to the content. An exit interview was conducted with participants to gather feedback on the intervention and further explore participants? perceptions of voice technology as a means to support perinatal health in the future. Results: In total, 19 pregnant women (17 to 36 weeks pregnant) were consented. Themes identified as important for perinatal health information include establishing routines, expected norms, and realistic expectations and providing key takeaways. Themes identified as important for voice interaction include customization and user preferences, privacy, family and friends, and context and convenience. Qualitative analysis suggested that perinatal health promotion content delivered by voice should be accurate and succinctly delivered and highlight key takeaways. Perinatal health interventions that use voice should provide users with the ability to customize the intervention but also provide opportunities to engage family members, particularly spouses. As a number of women multitasked while the intervention was being deployed, future interventions should leverage the convenience of voice technology while also balancing the influence of user context (eg, timing or ability to listen or talk versus nonvoice interaction with the system). Conclusions: Our findings demonstrate the short-term feasibility of disseminating evidence-based perinatal support via podcasts and curate voice-captured data from perinatal women. However, key areas of improvement have been identified specifically for perinatal interventions leveraging voice technology. Findings contribute to future content, design, and delivery considerations of perinatal digital health interventions. UR - https://formative.jmir.org/2021/3/e18240 UR - http://dx.doi.org/10.2196/18240 UR - http://www.ncbi.nlm.nih.gov/pubmed/33646136 ID - info:doi/10.2196/18240 ER - TY - JOUR AU - Hollander, B. Justin AU - Folta, C. Sara AU - Graves, Michelle Erin AU - Allen, D. Jennifer AU - Situ, Minyu PY - 2021/3/1 TI - A Fitness App for Monitoring Walking Behavior and Perception (Runkeeper): Mixed Methods Pilot Study JO - JMIR Form Res SP - e22571 VL - 5 IS - 3 KW - physical activity KW - smartphone KW - mobile app KW - sense of belongingness KW - community cohesion N2 - Background: Physical activity has a strong positive impact on both physical and mental health, and public health interventions often encourage walking as a means to promote physical activity. Social connectivity, such as that among spouses, families, friends, and colleagues, highly influences physical activity. Although technology-based interventions have some influence on human behavior, they have not been fully implemented and evaluated for their influence on walking through social connectivity. Objective: We aimed to pilot-test the organization of neighborhood walking clubs and use of a mobile app (Runkeeper) to encourage social connectedness and neighborhood cohesion, as well as to increase physical activity. Methods: We used a convenience sampling method to recruit 46 adults from an urban location in Greater Boston, Massachusetts. We assigned participants to teams based on their geographic location and neighborhood and required them to use the app (Runkeeper). Participants completed 2 self-administered web-based surveys before and after the intervention period. The surveys included standard measures to evaluate physical activity, social connectedness, perceived social support, and neighborhood cohesion (Buckner Neighborhood Cohesion Scale) before and after the intervention. Following the intervention, we randomly selected 14 participants to participate in postintervention, in-depth phone interviews to gain an understanding of their experiences. Results: This study was approved by the institutional review board in June 2018 and funded in January 2018. Recruitment started in May 2019 and lasted for 2 months. Data were collected from July 2019 to January 2020. In this study, Runkeeper was of limited feasibility as an app for measuring physical activity or promoting social connectedness. Data from the app recorded sparse and uneven walking behaviors among the participants. Qualitative interviews revealed that users experienced difficulties in using the settings and features of the app. In the questionnaire, there was no change between pre-post assessments in walking minutes (b=?.79; 95% CI ?4.0 to 2.4; P=.63) or miles (b=?.07; 95% CI ?0.15 to 0.01; P=.09). We observed a pre-post increase in social connectedness and a decrease in neighborhood cohesion. Both quantitative and qualitative results indicated that the psychosocial aspects of walking motivated the participants and helped them relieve stress. Interview results showed that participants felt a greater virtual connection in their assigned groups and enhanced connections with friends and family members. Conclusions: Our study found that Runkeeper created a virtual connection among walking group members and its data sharing and ranking motivated walking. Participants felt that walking improved their mental health, helped to relieve stress, and made them feel more connected with friends or family members. In future studies, it will be important to use an app that integrates with a wearable physical activity device. There is also a need to develop and test intervention components that might be more effective in fostering neighborhood cohesion. UR - https://formative.jmir.org/2021/3/e22571 UR - http://dx.doi.org/10.2196/22571 UR - http://www.ncbi.nlm.nih.gov/pubmed/33646132 ID - info:doi/10.2196/22571 ER - TY - JOUR AU - Alawadhi, Balqees AU - Fallaize, Rosalind AU - Franco, Zenun Rodrigo AU - Hwang, Faustina AU - Lovegrove, Julie PY - 2021/3/2 TI - Web-Based Dietary Intake Estimation to Assess the Reproducibility and Relative Validity of the EatWellQ8 Food Frequency Questionnaire: Validation Study JO - JMIR Form Res SP - e13591 VL - 5 IS - 3 KW - web-based KW - Kuwait KW - weighed food record KW - app KW - food frequency questionnaire KW - validation KW - dietary assessment N2 - Background: The web-based EatWellQ8 food frequency questionnaire (FFQ) was developed as a dietary assessment tool for healthy adults in Kuwait. Validation against reliable instruments and assessment of its reproducibility are required to ensure the accuracy of the EatWellQ8 FFQ in computing nutrient intake. Objective: This study aims to assess the reproducibility and relative validity of the EatWellQ8 146-item FFQ, which included images of food portion sizes based on The Composition of Foods by McCance and Widdowson and food composition tables from Kuwait and the Kingdom of Bahrain, against a paper-based FFQ (PFFQ) and a 4-day weighed food record (WFR). Methods: Reproducibility of the EatWellQ8 FFQ was assessed using a test-retest methodology. Participants were required to complete the FFQ at 2 time points, 4 weeks apart. To assess the relative validity of the EatWellQ8 FFQ, a subset of the participants were asked to complete a PFFQ or a 4-day WFR 1 week after the administration of the EatWellQ8 FFQ. The level of agreement between nutrient and food group intakes was estimated by repeated EatWellQ8 FFQ administration. The EatWellQ8 FFQ, PFFQ, and 4-day WFR were also evaluated using the Bland-Altman methodology and classified into quartiles of daily intake. Crude unadjusted correlation coefficients were also calculated for nutrients and food groups. Results: A total of 99 Kuwaiti participants (64/99, 65% female and 35/99, 35% male) completed the study?53 participated in the reproducibility study and the 4-day WFR validity study (mean age 37.1 years, SD 9.9) and 46 participated in the PFFQ validity study (mean age 36.2 years, SD 8.3). Crude unadjusted correlations for repeated EatWellQ8 FFQs ranged from 0.37 to 0.93 (mean r=0.67, SD 0.14; 95% CI 0.11-0.95) for nutrients and food groups (P=.01). Mean cross-classification into exact agreement plus adjacent was 88% for nutrient intakes and 86% for food groups, and Bland-Altman plots showed good agreement for energy-adjusted macronutrient intakes. The association between the EatWellQ8 FFQ and PFFQ varied, with crude unadjusted correlations ranging from 0.42 to 0.73 (mean r=0.46, SD 0.12; 95% CI ?0.02 to 0.84; P=.046). Mean cross-classification into exact agreement plus adjacent was 84% for nutrient intake and 74% for food groups. Bland-Altman plots showed moderate agreement for both energy and energy-controlled nutrient intakes. Crude unadjusted correlations for the EatWellQ8 FFQ and the 4-day WFR ranged from 0.40 to 0.88 (mean r=0.58, SD 0.13; 95% CI 0.01-0.58; P=.01). Mean cross-classification into exact agreement plus adjacent was 85% for nutrient intake and 83% for food groups. Bland-Altman plots showed moderate agreement for energy-adjusted macronutrient intakes. Conclusions: The results indicate that the web-based EatWellQ8 FFQ is reproducible for assessing nutrient and food group intake and has moderate agreement compared with a PFFQ and a 4-day WFR for measuring energy and nutrient intakes. UR - https://formative.jmir.org/2021/3/e13591 UR - http://dx.doi.org/10.2196/13591 UR - http://www.ncbi.nlm.nih.gov/pubmed/33650974 ID - info:doi/10.2196/13591 ER - TY - JOUR AU - Heidary, Zahra AU - Cochran, M. Jeffrey AU - Peters-Strickland, Timothy AU - Knights, Jonathan PY - 2021/3/2 TI - A Rest Quality Metric Using a Cluster-Based Analysis of Accelerometer Data and Correlation With Digital Medicine Ingestion Data: Algorithm Development JO - JMIR Form Res SP - e17993 VL - 5 IS - 3 KW - serious mental illness KW - rest quality KW - actimetry KW - behavioral health KW - digital medicine KW - accelerometer KW - medication adherence N2 - Background: Adherence to medication regimens and patient rest are two important factors in the well-being of patients with serious mental illness. Both of these behaviors are traditionally difficult to record objectively in unsupervised populations. Objective: A digital medicine system that provides objective time-stamped medication ingestion records was used by patients with serious mental illness. Accelerometer data from the digital medicine system was used to assess rest quality and thus allow for investigation into correlations between rest and medication ingestion. Methods: Longest daily rest periods were identified and then evaluated using a k-means clustering algorithm and distance metric to quantify the relative quality of patient rest during these periods. This accelerometer-derived quality-of-rest metric, along with other accepted metrics of rest quality, such as duration and start time of the longest rest periods, was compared to the objective medication ingestion records. Overall medication adherence classification based on rest features was not performed due to a lack of patients with poor adherence in the sample population. Results: Explorations of the relationship between these rest metrics and ingestion did seem to indicate that patients with poor adherence experienced relatively low quality of rest; however, patients with better adherence did not necessarily exhibit consistent rest quality. This sample did not contain sufficient patients with poor adherence to draw more robust correlations between rest quality and ingestion behavior. The correlation of temporal outliers in these rest metrics with daily outliers in ingestion time was also explored. Conclusions: This result demonstrates the ability of digital medicine systems to quantify patient rest quality, providing a framework for further work to expand the participant population, compare these rest metrics to gold-standard sleep measurements, and correlate these digital medicine biomarkers with objective medication ingestion data. UR - https://formative.jmir.org/2021/3/e17993 UR - http://dx.doi.org/10.2196/17993 UR - http://www.ncbi.nlm.nih.gov/pubmed/33650981 ID - info:doi/10.2196/17993 ER - TY - JOUR AU - Mbao, Mbita AU - Collins-Pisano, Caroline AU - Fortuna, Karen PY - 2021/3/2 TI - Older Adult Peer Support Specialists? Age-Related Contributions to an Integrated Medical and Psychiatric Self-Management Intervention: Qualitative Study of Text Message Exchanges JO - JMIR Form Res SP - e22950 VL - 5 IS - 3 KW - older adults KW - peer support KW - self-management KW - mobile technology N2 - Background: Middle-aged and older adults with mental health conditions have a high likelihood of experiencing comorbid physical health conditions, premature nursing home admissions, and early death compared with the general population of adults aged 50 years or above. An emerging workforce of peer support specialists aged 50 years or above or ?older adult peer support specialists? is increasingly using technology to deliver peer support services to address both the mental health and physical health needs of middle-aged and older adults with a diagnosis of a serious mental illness. Objective: This exploratory qualitative study examined older adult peer support specialists? text message exchanges with middle-aged and older adults with a diagnosis of a serious mental illness and their nonmanualized age-related contributions to a standardized integrated medical and psychiatric self-management intervention. Methods: Older adult peer support specialists exchanged text messages with middle-aged and older adults with a diagnosis of a serious mental illness as part of a 12-week standardized integrated medical and psychiatric self-management smartphone intervention. Text message exchanges between older adult peer support specialists (n=3) and people with serious mental illnesses (n=8) were examined (mean age 68.8 years, SD 4.9 years). A total of 356 text messages were sent between older adult peer support specialists and service users with a diagnosis of a serious mental illness. Older adult peer support specialists sent text messages to older participants? smartphones between 8 AM and 10 PM on weekdays and weekends. Results: Five themes emerged from text message exchanges related to older adult peer support specialists? age-related contributions to integrated self-management, including (1) using technology to simultaneously manage mental health and physical health issues; (2) realizing new coping skills in late life; (3) sharing roles as parents and grandparents; (4) wisdom; and (5) sharing lived experience of difficulties with normal age-related changes (emerging). Conclusions: Older adult peer support specialists? lived experience of aging successfully with a mental health challenge may offer an age-related form of peer support that may have implications for promoting successful aging in older adults with a serious mental illness. UR - https://formative.jmir.org/2021/3/e22950 UR - http://dx.doi.org/10.2196/22950 UR - http://www.ncbi.nlm.nih.gov/pubmed/33650979 ID - info:doi/10.2196/22950 ER - TY - JOUR AU - Liverpool, Shaun AU - Edbrooke-Childs, Julian PY - 2021/3/2 TI - Feasibility and Acceptability of a Digital Intervention to Support Shared Decision-making in Children?s and Young People?s Mental Health: Mixed Methods Pilot Randomized Controlled Trial JO - JMIR Form Res SP - e25235 VL - 5 IS - 3 KW - mental health KW - pilot projects KW - child KW - adolescent KW - parents KW - shared decision making N2 - Background: Interventions to involve parents in decisions regarding children?s and young people?s mental health are associated with positive outcomes. However, appropriately planning effectiveness studies is critical to ensure that meaningful evidence is collected. It is important to conduct pilot studies to evaluate the feasibility and acceptability of the intervention itself and the feasibility of the protocol to test effectiveness. Objective: This paper reports the findings from a feasibility and acceptability study of Power Up for Parents, an intervention to promote shared decision-making (SDM) and support parents and caregivers making decisions regarding children?s and young people?s mental health. Methods: A mixed method study design was adopted. In stage 1, health care professionals and parents provided feedback on acceptability, usefulness, and suggestions for further development. Stage 2 was a multicenter, 3-arm, individual, and cluster randomized controlled pilot feasibility trial with parents accessing services related to children?s and young people?s mental health. Outcome measures collected data on demographics, participation rates, SDM, satisfaction, and parents? anxiety. Qualitative data were analyzed using thematic analysis. Google Analytics estimates were used to report engagement with the prototype. Outcomes from both stages were tested against a published set of criteria for proceeding to a randomized controlled trial. Results: Despite evidence suggesting the acceptability of Power Up for Parents, the findings suggest that recruitment modifications are needed to enhance the feasibility of collecting follow-up data before scaling up to a fully powered randomized controlled trial. On the basis of the Go or No-Go criteria, only 50% (6/12) of the sites successfully recruited participants, and only 38% (16/42) of parents completed follow-up measures. Nonetheless, health care practitioners and parents generally accessed and used the intervention. Themes describing appearance and functionality, perceived need and general helpfulness, accessibility and appropriateness, and a wish list for improvement emerged, providing valuable information to inform future development and refinement of the intervention. Conclusions: Owing to the high attrition observed in the trial, proceeding directly to a full randomized controlled trial may not be feasible with this recruitment strategy. Nonetheless, with some minor adjustments and upgrades to the intervention, this pilot study provides a platform for future evaluations of Power Up for Parents. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 39238984; http://www.isrctn.com/ISRCTN39238984. International Registered Report Identifier (IRRID): RR2-10.2196/14571 UR - https://formative.jmir.org/2021/3/e25235 UR - http://dx.doi.org/10.2196/25235 UR - http://www.ncbi.nlm.nih.gov/pubmed/33650973 ID - info:doi/10.2196/25235 ER - TY - JOUR AU - Moreno, Georgina AU - van Mierlo, Trevor PY - 2021/3/2 TI - A Digital Health Tool to Understand and Prevent Cannabis-Impaired Driving Among Youth: A Cross-sectional Study of Responses to a Brief Intervention for Cannabis Use JO - JMIR Form Res SP - e25583 VL - 5 IS - 3 KW - cannabis use KW - driving after cannabis use KW - internet KW - intervention KW - online intervention KW - digital health KW - cannabis KW - drug KW - online tool KW - youth KW - adolescent KW - Canada N2 - Background: Cannabis legalization has raised concern about an increased risk of cannabis-impaired driving, particularly among youth. Youth advocates and policy makers require cost-effective tools to target educational resources to promote responsible cannabis use. Objective: The objective of this paper is threefold. First, it describes how a youth advocacy organization disseminated a low-cost digital brief intervention to educate and inform young people about responsible cannabis use. Second, it illustrates how digital tools can help promote understanding about attitudes and behaviors toward cannabis while simultaneously offering tailored education. Finally, this paper contributes to examining behavioral factors associated with youth cannabis-impaired driving by quantifying relationships between cannabis users' willingness to drive impaired and self-reported demographic and behavioral factors. Methods: This paper analyzed data from 1110 completed Check Your Cannabis (CYC) brief interventions between March 2019 and October 2020. The CYC asks respondents a brief set of questions about their cannabis use and their personal beliefs and behaviors. Respondents receive comprehensive feedback about their cannabis use and how it compares with others. They also receive a summary of reported behaviors with brief advice. An ordered probit model was used to test relationships between cannabis use, demographics, and driving behaviors to gain further insights. Results: The vast majority (817/1110, 73.6%) of respondents reported using cannabis. However, a much smaller share of respondents reported problems associated with their cannabis use (257/1110, 23.2%) or driving after cannabis use (342/1110, 30.8%). We found statistically significant relationships between driving after cannabis use and age; Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) risk score; and polysubstance use. However, we did not find gender to be a significant determinant of driving after cannabis use. We estimated that every 10-point increase in the ASSIST score increased the probability of sometimes driving after cannabis use by 7.3% (P<.001). Relative to respondents who reported never drinking alcohol or using other substances with cannabis, those who sometimes drink or use other substances with cannabis were 13% (P<.001) more likely to sometimes or always drive after using cannabis. Conclusions: The digital health tool cost the youth advocacy organization approximately Can $0.90 (US $0.71) per use. Due to the tool's unlimited use structure, the per-use cost would further decrease with increased use by the organization?s target population. Based on our results, public health campaigns and other interventions may consider tailoring resources to frequent cannabis users, youth with high ASSIST scores, and those with polysubstance abuse. The cost-effectiveness of delivering digital brief interventions with unlimited use is attractive, as increased use decreases the per-user cost. Further research examining the efficacy of digital health interventions targeting problematic cannabis use is required. UR - https://formative.jmir.org/2021/3/e25583 UR - http://dx.doi.org/10.2196/25583 UR - http://www.ncbi.nlm.nih.gov/pubmed/33650982 ID - info:doi/10.2196/25583 ER - TY - JOUR AU - Carrotte, Rose Elise AU - Webb, Marianne AU - Flego, Anna AU - Vincent, Bonnie AU - Heath, Jack AU - Blanchard, Michelle PY - 2021/3/3 TI - Acceptability, Safety, and Resonance of the Pilot Digital Suicide Prevention Campaign ?Better Off With You?: Qualitative Study JO - JMIR Form Res SP - e23892 VL - 5 IS - 3 KW - suicide KW - interpersonal theory of suicide KW - social media KW - co-design KW - lived experience N2 - Background: The Interpersonal Theory of Suicide posits that there are three key elements of suicidal behavior: perceived burdensomeness, thwarted belongingness, and the acquired capability for suicide. The digital campaign Better Off With You was developed to directly challenge the idea of perceived burdensomeness among people who are contemplating suicide in 2 communities within Australia. Objective: The aim of this study is to explore the needs and preferences of people with lived experience of suicidal thoughts and actions to inform the development of Better Off With You. Methods: This study involved a series of focus groups that aimed to discuss campaign messaging, scope, and approach. People with lived experience of suicidal thoughts and actions attended the focus groups. After the completion of initial focus groups, the results informed the creation of campaign collateral by creative agencies. Early versions of the campaign collateral were then presented in the user testing sessions. Transcriptions were analyzed via thematic analysis. Results: In total, 13 participants attended the focus groups and 14 attended the user testing sessions. The following three overarching themes were presented: acceptability, safety, and resonance. Participants believed that suicide is a serious and ongoing issue in their communities and welcomed a localized suicide prevention focus via peer-to-peer storytelling. The idea of perceived burdensomeness required clarification but was perceived as acceptable and relevant. Participants seemed drawn toward peer narratives that they perceived to be authentic, genuine, and believable as given by real people with lived experience. Campaign messaging needs to be clear and empathetic while directly talking about suicide. Participants did not anticipate any significant negative or harmful impact from any campaign videos and highlighted the importance of providing appropriate help-seeking information. Conclusions: This iterative study provided important insights and knowledge about peer-to-peer storytelling in suicide prevention campaigns. Future campaigns should involve simple messaging, be validating and empathetic, and consider including a lived experience perspective. UR - https://formative.jmir.org/2021/3/e23892 UR - http://dx.doi.org/10.2196/23892 UR - http://www.ncbi.nlm.nih.gov/pubmed/33656441 ID - info:doi/10.2196/23892 ER - TY - JOUR AU - Roux de Bézieux, Hector AU - Bullard, James AU - Kolterman, Orville AU - Souza, Michael AU - Perraudeau, Fanny PY - 2021/3/4 TI - Medical Food Assessment Using a Smartphone App With Continuous Glucose Monitoring Sensors: Proof-of-Concept Study JO - JMIR Form Res SP - e20175 VL - 5 IS - 3 KW - clinical trials KW - continuous glucose monitoring KW - lifestyle modification KW - mobile app KW - telemedicine KW - diabetes N2 - Background: Novel wearable biosensors, ubiquitous smartphone ownership, and telemedicine are converging to enable new paradigms of clinical research. A new generation of continuous glucose monitoring (CGM) devices provides access to clinical-grade measurement of interstitial glucose levels. Adoption of these sensors has become widespread for the management of type 1 diabetes and is accelerating in type 2 diabetes. In parallel, individuals are adopting health-related smartphone-based apps to monitor and manage care. Objective: We conducted a proof-of-concept study to investigate the potential of collecting robust, annotated, real-time clinical study measures of glucose levels without clinic visits. Methods: Self-administered meal-tolerance tests were conducted to assess the impact of a proprietary synbiotic medical food on glucose control in a 6-week, double-blind, placebo-controlled, 2×2 cross-over pilot study (n=6). The primary endpoint was incremental glucose measured using Abbott Freestyle Libre CGM devices associated with a smartphone app that provided a visual diet log. Results: All subjects completed the study and mastered CGM device usage. Over 40 days, 3000 data points on average per subject were collected across three sensors. No adverse events were recorded, and subjects reported general satisfaction with sensor management, the study product, and the smartphone app, with an average self-reported satisfaction score of 8.25/10. Despite a lack of sufficient power to achieve statistical significance, we demonstrated that we can detect meaningful changes in the postprandial glucose response in real-world settings, pointing to the merits of larger studies in the future. Conclusions: We have shown that CGM devices can provide a comprehensive picture of glucose control without clinic visits. CGM device usage in conjunction with our custom smartphone app can lower the participation burden for subjects while reducing study costs, and allows for robust integration of multiple valuable data types with glucose levels remotely. Trial Registration: ClinicalTrials.gov NCT04424888; http://clinicaltrials.gov/ct2/show/NCT04424888. UR - https://formative.jmir.org/2021/3/e20175 UR - http://dx.doi.org/10.2196/20175 UR - http://www.ncbi.nlm.nih.gov/pubmed/33661120 ID - info:doi/10.2196/20175 ER - TY - JOUR AU - Silsand, Line AU - Severinsen, Gro-Hilde AU - Berntsen, Gro PY - 2021/3/5 TI - Preservation of Person-Centered Care Through Videoconferencing for Patient Follow-up During the COVID-19 Pandemic: Case Study of a Multidisciplinary Care Team JO - JMIR Form Res SP - e25220 VL - 5 IS - 3 KW - person-centered care KW - rapid digitalization KW - health care KW - videoconferencing KW - persons with complex, long-term needs KW - COVID-19 N2 - Background: The Patient-Centered Team (PACT) focuses on the transitional phase between hospital and primary care for older patients in Northern Norway with complex and long-term needs. PACT emphasizes a person-centered care approach whereby the sharing of power and the patient?s response to ?What matters to you?? drive care decisions. However, during the COVID-19 pandemic, videoconferencing was the only option for assessing, planning, coordinating, and performing treatment and care. Objective: The aim of this study is to report the experience of the PACT multidisciplinary health care team in shifting rapidly from face-to-face care to using videoconferencing for clinical and collaborative services during the initial phase of the COVID-19 pandemic. This study explores how PACT managed to maintain person-centered care under these conditions. Methods: This case study takes a qualitative approach based on four semistructured focus group interviews carried out in May and June 2020 with 19 PACT members and leaders. Results: The case study illustrates that videoconferencing is a good solution for many persons with complex and long-term needs and generates new opportunities for interaction between patients and health care personnel. Persons with complex and long-term needs are a heterogeneous group, and for many patients with reduced cognitive capacity or hearing and vision impairment, the use of videoconferencing was challenging and required support from relatives or health care personnel. The study shows that using videoconferencing offered an opportunity to use health care personnel more efficiently, reduce travelling time for patients, and improve the information exchange between health care levels. This suggests that the integration of videoconferencing contributed to the preservation of the person-centered focus on care during the COVID-19 pandemic. There was an overall agreement in PACT that face-to-face care needed to be at the core of the person-centered care approach; the main use of videoconferencing was to support follow-up and coordination. Conclusions: The COVID-19 pandemic and the rapid adoption of digital care have generated a unique opportunity to continue developing a health service to both preserve and improve the person-centered care approach for persons with complex and long-term needs. This creates demand for overall agreements, including guidelines and procedures for how and when to use videoconferencing to supplement face-to-face treatment and care. Implementing videoconferencing in clinical practice generates a need for systematic training and familiarization with the equipment and technology as well as for an extensive support organization. Videoconferencing can then contribute to better preparing health care services for future scenarios. UR - https://formative.jmir.org/2021/3/e25220 UR - http://dx.doi.org/10.2196/25220 UR - http://www.ncbi.nlm.nih.gov/pubmed/33646965 ID - info:doi/10.2196/25220 ER - TY - JOUR AU - Okpara, S. Kelechi AU - Hecht, Jennifer AU - Wohlfeiler, Dan AU - Prior, Matthew AU - Klausner, D. Jeffrey PY - 2021/3/5 TI - A Patient-Initiated Digital COVID-19 Contact Notification Tool (TellYourContacts): Evaluation Study JO - JMIR Form Res SP - e23843 VL - 5 IS - 3 KW - patient-led digital contact notification KW - COVID-19 KW - digital contact tracing KW - contact notification website N2 - Background: Contact notification is a method used to control the spread of infectious disease. In this process, a patient who tests positive for an infectious disease and public health officials work to identify the patient?s close contacts, notify them of their risk of possible exposure to the disease, and provide resources to facilitate the decreased spreading of disease. Contact notification can be done physically in person, via phone call, or digitally through the use of media such as SMS text messages and email. When alerts are made through the latter, it is called digital contact notification. Objective: For this study, we aim to perform a preliminary evaluation of the use of the TellYourContacts website, a digital contact notification tool for COVID-19 that can be used confidentially and anonymously. We will gather information about the number of website users and message senders, the types of messages sent, and the geographic distribution of senders. Methods: Patients who chose to get tested for COVID-19 and subsequently tested positive for the disease were alerted of their positive results through Curative Inc (a COVID-19 testing laboratory) and Healthvana (a results disclosure app). Included in the notification was a link to the TellYourContacts website and a message encouraging the person who tested positive for COVID-19 to use the website to alert their close contacts of exposure risk. Over the course of three months, from May 18, 2020, to August 17, 2020, we used Google Analytics and Microsoft Excel to record data on the number of website users and message senders, types of messages sent, and geographic distribution of the senders. Results: Over the course of three months, 9130 users accessed the website and 1474 unique senders sent a total of 1957 messages, which included 1820 (93%) SMS text messages and 137 (7%) emails. Users sent messages from 40 US states, with the majority of US senders residing in California (49%). Conclusions: We set out to determine if individuals who test positive for COVID-19 will use the TellYourContacts website to notify their close contacts of COVID-19 exposure risk. Our findings reveal that, during the observation period, each unique sender sent an average of 1.33 messages. The TellYourContacts website offers an additional method that individuals can and will use to notify their close contacts about a recent COVID-19 diagnosis. UR - https://formative.jmir.org/2021/3/e23843 UR - http://dx.doi.org/10.2196/23843 UR - http://www.ncbi.nlm.nih.gov/pubmed/33621189 ID - info:doi/10.2196/23843 ER - TY - JOUR AU - Naqvi, Ali Imama AU - Montiel, Casameni Tahani AU - Bittar, Yazan AU - Hunter, Norma AU - Okpala, Munachi AU - Johnson, Constance AU - Weiner, G. Mark AU - Savitz, Sean AU - Sharrief, Anjail AU - Beauchamp, Sanner Jennifer Elizabeth PY - 2021/3/8 TI - Internet Access and Usage Among Stroke Survivors and Their Informal Caregivers: Cross-sectional Study JO - JMIR Form Res SP - e25123 VL - 5 IS - 3 KW - internet access KW - stroke KW - caregivers KW - surveys KW - questionnaires KW - mobile phone N2 - Background: Web-based interventions have shown promise for chronic disease management but have not been widely applied to populations with stroke. Existing barriers may inhibit the adoption of web-based interventions among stroke survivors and necessitate the involvement of informal caregivers. However, limited information is available on internet accessibility and usability among stroke survivors and their caregivers. Objective: This study aims to investigate internet access and usage in a cohort of stroke survivors and their caregivers. Methods: A cross-sectional survey was conducted with 375 participants (248 stroke survivors and 127 caregivers). Descriptive statistics were generated using cross-tabulation. Comparisons with categorical data were conducted using the chi-square test, whereas the Mann-Whitney U test was used for comparisons involving ordinal variables. Results: Overall, 86.1% (323/375) of the participants reported having internet access. Caregivers were more likely than stroke survivors to access the internet (N=375, ?21=18.5, P<.001) and used text messaging (n=321, ?21=14.7, P<.001). Stroke survivors and caregivers with internet access were younger than stroke survivors and caregivers without internet access. The highest number of participants who reported internet access were non-Hispanic White. Smartphones were the most common devices used to access the internet. Email was the most common type of internet usage reported. Patients who survived for >12 months after a stroke reported higher internet access than those who survived <3 months (P<.001). The number of hours per week spent using the internet was higher for caregivers than for stroke survivors (P<.001). Conclusions: Future feasibility and acceptability studies should consider the role of the informal caregiver, participant age, race and ethnicity, the use of smartphone apps, email and text correspondence, and the amount of time elapsed since the stroke event in the design and implementation of web-based interventions for populations with stroke. UR - https://formative.jmir.org/2021/3/e25123 UR - http://dx.doi.org/10.2196/25123 UR - http://www.ncbi.nlm.nih.gov/pubmed/33683206 ID - info:doi/10.2196/25123 ER - TY - JOUR AU - White, M. Katie AU - Ivan, Alina AU - Williams, Ruth AU - Galloway, B. James AU - Norton, Sam AU - Matcham, Faith PY - 2021/3/9 TI - Remote Measurement in Rheumatoid Arthritis: Qualitative Analysis of Patient Perspectives JO - JMIR Form Res SP - e22473 VL - 5 IS - 3 KW - rheumatoid arthritis KW - remote measurement technologies KW - symptom assessment KW - disease management KW - smartphone KW - qualitative research KW - mobile phone N2 - Background: Rheumatoid arthritis (RA) is characterized by recurrent fluctuations in symptoms such as joint pain, swelling, and stiffness. Remote measurement technologies (RMTs) offer the opportunity to track symptoms continuously and in real time; therefore, they may provide a more accurate picture of RA disease activity as a complement to prescheduled general practitioner appointments. Previous research has shown patient interest in remote symptom tracking in RA and has provided evidence for its clinical validity. However, there is a lack of co-design in the current development of systems, and the features of RMTs that best promote optimal engagement remain unclear. Objective: This study represents the first in a series of work that aims to develop a multiparametric RMT system for symptom tracking in RA. The objective of this study is to determine the important outcomes for disease management in patients with RA and how these can be best captured via remote measurement. Methods: A total of 9 patients (aged 23-77 years; mean 55.78, SD 17.54) with RA were recruited from King?s College Hospital to participate in two semistructured focus groups. Both focus group discussions were conducted by a facilitator and a lived-experience researcher. The sessions were recorded, transcribed, independently coded, and analyzed for themes. Results: Thematic analysis identified a total of four overarching themes: important symptoms and outcomes in RA, management of RA symptoms, views on the current health care system, and views on the use of RMTs in RA. Mobility and pain were key symptoms to consider for symptom tracking as well as symptom triggers. There is a general consensus that the ability to track fluctuations and transmit such data to clinicians would aid in individual symptom management and the effectiveness of clinical care. Suggestions for visually capturing symptom fluctuations in an app were proposed. Conclusions: The findings support previous work on the acceptability of RMT with RA disease management and address key outcomes for integration into a remote monitoring system for RA self-management and clinical care. Clear recommendations for RMT design are proposed. Future work will aim to take these recommendations into a user testing phase. UR - https://formative.jmir.org/2021/3/e22473 UR - http://dx.doi.org/10.2196/22473 UR - http://www.ncbi.nlm.nih.gov/pubmed/33687333 ID - info:doi/10.2196/22473 ER - TY - JOUR AU - Wolbers, Roos AU - Bode, Christina AU - Siemerink, Ester AU - Siesling, Sabine AU - Pieterse, Marcel PY - 2021/3/10 TI - Cognitive Bias Modification Training to Improve Implicit Vitality in Patients With Breast Cancer: App Design Using a Cocreation Approach JO - JMIR Form Res SP - e18325 VL - 5 IS - 3 KW - breast cancer KW - cognitive bias modification KW - eHealth KW - fatigue KW - oncology KW - psychology KW - vitality N2 - Background: More than 50% of all patients with breast cancer experience fatigue symptoms during and after their treatment course. Recent evidence has shown that fatigue is partly driven by cognitive biases such as the self-as-fatigued identity bias, which may be corrected with computer-based cognitive bias modification (CBM) techniques. Objective: The aim of this study was to design a CBM-training app by adopting a cocreation approach. Methods: Semistructured interviews were conducted with 7 health care professionals, 3 patients with breast cancer, and 2 patient advocates. The aim of the interviews was to collect input for the design of the CBM training, taking the values and preferences of the stakeholders into account, and to determine the timing and implementation of the training in the treatment course. Results: Overall, the interviews showed that the concept of CBM was accepted among all stakeholders. Important requirements were revealed such as the training needs to be simple and undemanding, yet engaging and persuasive. Based on the results, an eHealth app IVY (Implicit VitalitY) was created. The findings from the interviews suggested that IVY should be offered early in the breast cancer treatment course and should be carefully aligned with clinical treatment. Conclusions: The findings of this study show that using CBM as a preventive approach to target cancer-related fatigue is an innovative technique, and this approach was embraced by breast cancer stakeholders. Our study suggests that CBM training has several benefits such as being easy to use and potentially increasing perceived self-control in patients. UR - https://formative.jmir.org/2021/3/e18325 UR - http://dx.doi.org/10.2196/18325 UR - http://www.ncbi.nlm.nih.gov/pubmed/33688833 ID - info:doi/10.2196/18325 ER - TY - JOUR AU - Furness, Kate AU - Huggins, Elizabeth Catherine AU - Truby, Helen AU - Croagh, Daniel AU - Haines, Peter Terry PY - 2021/3/12 TI - Attitudes of Australian Patients Undergoing Treatment for Upper Gastrointestinal Cancers to Different Models of Nutrition Care Delivery: Qualitative Investigation JO - JMIR Form Res SP - e23979 VL - 5 IS - 3 KW - qualitative KW - upper gastrointestinal KW - cancer KW - nutrition KW - mobile phone N2 - Background: Adults diagnosed with cancers of the stomach, esophagus, and pancreas are at high risk of malnutrition. In many hospital-based health care settings, there is a lack of systems in place to provide the early and intensive nutritional support that is required by these high-risk cancer patients. Our research team conducted a 3-arm parallel randomized controlled trial to test the provision of an early and intensive nutrition intervention to patients with upper gastrointestinal cancers using a synchronous telephone-based delivery approach versus an asynchronous mobile app?based approach delivered using an iPad compared with a control group to address this issue. Objective: This study aims to explore the overall acceptability of an early and intensive eHealth nutrition intervention delivered either via a synchronous telephone-based approach or an asynchronous mobile app?based approach. Methods: Patients who were newly diagnosed with upper gastrointestinal cancer and who consented to participate in a nutrition intervention were recruited. In-depth, semistructured qualitative interviews were conducted by telephone and transcribed verbatim. Data were analyzed using deductive thematic analysis using the Theoretical Framework of Acceptability in NVivo Pro 12 Plus. Results: A total of 20 participants were interviewed, 10 from each intervention group (synchronous or asynchronous delivery). Four major themes emerged from the qualitative synthesis: participants? self-efficacy, low levels of burden, and intervention comprehension were required for intervention effectiveness and positive affect; participants sought a sense of support and security through relationship building and rapport with their dietitian; knowledge acquisition and learning-enabled empowerment through self-management; and convenience, flexibility, and bridging the gap to hard-to-reach individuals. Conclusions: Features of eHealth models of nutrition care delivered via telephone and mobile app can be acceptable to those undergoing treatment for upper gastrointestinal cancer. Convenience, knowledge acquisition, improved self-management, and support were key benefits for the participants. Future interventions should focus on home-based interventions delivered with simple, easy-to-use technology. Providing participants with a choice of intervention delivery mode (synchronous or asynchronous) and allowing them to make individual choices that align to their individual values and capabilities may support improved outcomes. Trial Registration: Australian and New Zealand Clinical Trial Registry (ACTRN) 12617000152325; https://tinyurl.com/p3kxd37b. UR - https://formative.jmir.org/2021/3/e23979 UR - http://dx.doi.org/10.2196/23979 UR - http://www.ncbi.nlm.nih.gov/pubmed/33709939 ID - info:doi/10.2196/23979 ER - TY - JOUR AU - Lindsay, Sally AU - Kolne, Kendall AU - Barker, J. Donna AU - Colantonio, Angela AU - Stinson, Jennifer AU - Moll, Sandra AU - Thomson, Nicole PY - 2021/3/15 TI - Exploration of Gender-Sensitive Care in Vocational Rehabilitation Providers Working With Youth With Disabilities: Codevelopment of an Educational Simulation JO - JMIR Form Res SP - e23568 VL - 5 IS - 3 KW - continuing education KW - gender-identity KW - gender-sensitive care KW - rehabilitation N2 - Background: Although research shows that there is a need for gender-specific vocational support to help youth with disabilities find employment, health care providers often report needing more training in this area. Currently, there are no existing educational simulations of gender-sensitive care within vocational rehabilitation for clinicians who provide care to youth with disabilities. Therefore, developing further educational tools that address gender-sensitive care could help them enhance the care they provide while optimizing patient outcomes. Objective: This study aims to codevelop an educational simulation and identify issues relevant to providing gender-sensitive care within the context of vocational rehabilitation for youth with disabilities. Methods: We used a qualitative co-design approach with a purposive sampling strategy that involved focus group discussions and journal reflections to understand and address issues relevant to gender-sensitive care within vocational rehabilitation for those working with youth with disabilities. A total of 10 rehabilitation providers participated in two sessions (5 participants per session) to design the web-based simulation tool. The sessions (2.5 hours each) were audio recorded, transcribed, and analyzed thematically. Results: Two main themes arose from our analysis of codeveloping a simulation focusing on gender-sensitive care. The first theme involved the relevance of gender within clinical practice; responses varied from hesitance to acknowledging but not talking about it to those who incorporated gender into their practice. The second theme focused on creating a comfortable and safe space to enable gender-sensitive care (ie, included patient-centered care, effective communication and rapport building, appropriate language and pronoun use, respecting gender identity, awareness of stereotypes, and responding to therapeutic ruptures). Conclusions: Our web-based gender-sensitive care simulation that addressed vocational rehabilitation among youth with disabilities was cocreated with clinicians. The simulation highlights many issues relevant to clinical practice and has potential as an educational tool for those working with young people with disabilities. UR - https://formative.jmir.org/2021/3/e23568 UR - http://dx.doi.org/10.2196/23568 UR - http://www.ncbi.nlm.nih.gov/pubmed/33720023 ID - info:doi/10.2196/23568 ER - TY - JOUR AU - Ammar, Nariman AU - Bailey, E. James AU - Davis, L. Robert AU - Shaban-Nejad, Arash PY - 2021/3/16 TI - Using a Personal Health Library?Enabled mHealth Recommender System for Self-Management of Diabetes Among Underserved Populations: Use Case for Knowledge Graphs and Linked Data JO - JMIR Form Res SP - e24738 VL - 5 IS - 3 KW - personal health library KW - mobile health KW - personal health knowledge graph KW - patient-centered design KW - personalized health KW - recommender system KW - observations of daily living KW - Semantic Web KW - privacy N2 - Background: Traditionally, digital health data management has been based on electronic health record (EHR) systems and has been handled primarily by centralized health providers. New mechanisms are needed to give patients more control over their digital health data. Personal health libraries (PHLs) provide a single point of secure access to patients' digital health data and enable the integration of knowledge stored in their digital health profiles with other sources of global knowledge. PHLs can help empower caregivers and health care providers to make informed decisions about patients? health by understanding medical events in the context of their lives. Objective: This paper reports the implementation of a mobile health digital intervention that incorporates both digital health data stored in patients? PHLs and other sources of contextual knowledge to deliver tailored recommendations for improving self-care behaviors in diabetic adults. Methods: We conducted a thematic assessment of patient functional and nonfunctional requirements that are missing from current EHRs based on evidence from the literature. We used the results to identify the technologies needed to address those requirements. We describe the technological infrastructures used to construct, manage, and integrate the types of knowledge stored in the PHL. We leverage the Social Linked Data (Solid) platform to design a fully decentralized and privacy-aware platform that supports interoperability and care integration. We provided an initial prototype design of a PHL and drafted a use case scenario that involves four actors to demonstrate how the proposed prototype can be used to address user requirements, including the construction and management of the PHL and its utilization for developing a mobile app that queries the knowledge stored and integrated into the PHL in a private and fully decentralized manner to provide better recommendations. Results: To showcase the main features of the mobile health app and the PHL, we mapped those features onto a framework comprising the user requirements identified in a use case scenario that features a preventive intervention from the diabetes self-management domain. Ongoing development of the app requires a formative evaluation study and a clinical trial to assess the impact of the digital intervention on patient-users. We provide synopses of both study protocols. Conclusions: The proposed PHL helps patients and their caregivers take a central role in making decisions regarding their health and equips their health care providers with informatics tools that support the collection and interpretation of the collected knowledge. By exposing the PHL functionality as an open service, we foster the development of third-party applications or services and provide motivational technological support in several projects crossing different domains of interest. UR - https://formative.jmir.org/2021/3/e24738 UR - http://dx.doi.org/10.2196/24738 UR - http://www.ncbi.nlm.nih.gov/pubmed/33724197 ID - info:doi/10.2196/24738 ER - TY - JOUR AU - Van de Winckel, Ann AU - Nawshin, Tanjila AU - Byron, Casey PY - 2021/3/18 TI - Combining a Hudl App With Telehealth to Increase Home Exercise Program Adherence in People With Chronic Diseases Experiencing Financial Distress: Randomized Controlled Trial JO - JMIR Form Res SP - e22659 VL - 5 IS - 3 KW - chronic disease KW - spinal cord injury KW - stroke KW - telehealth KW - telemedicine KW - traumatic brain injury N2 - Background: Patients with chronic diseases often need to adhere to long-term individualized home exercise programs (HEPs). Limited adherence to long-term exercise given during physical therapy (PT) visits reduces the capacity of exercise to manage or improve symptoms related to chronic disease. In addition, a lower socioeconomic status negatively impacts exercise adherence. To mitigate this, apps that motivate people to exercise could be a viable option. Using an app through telehealth may help adults with chronic diseases to achieve long-term HEP adherence. However, because apps for rehabilitation are an emerging field, the feasibility of the app needs to be evaluated. Objective: To address HEP adherence in participants with chronic diseases who are experiencing financial distress, we aim to evaluate the feasibility of and satisfaction with the Hudl Technique app and telehealth and satisfaction with PT care and to monitor HEP adherence and compliance (ie, percentage of participant-recorded videos sent) in participants using the app with telehealth compared with those using standard HEPs on paper. Methods: We recruited patients scheduled for outpatient PT. We performed a randomized controlled trial in which the experimental group received weekly HEP demonstrations through app videos on a tablet with feedback on their self-recorded HEP video performance from the telehealth physical therapist. The control group received HEPs on paper without feedback, as is customary in PT practice. Demographic, clinical, and health coverage information was collected for screening and baseline measurements. Adherence and compliance were evaluated. Both groups completed surveys at 8 and 24 weeks on their satisfaction with PT care, and the experimental group also completed a survey on their satisfaction with the app with telehealth use. Descriptive and nonparametric statistics were used for within-group and between-group comparisons and analyzed with JMP, version 13. Results: Overall, 45 adults with chronic diseases who were experiencing financial distress were randomized into experimental (23/45, 51%) and control (22/45, 49%) groups, with 74% (17/23) and 86% (19/22) participants completing the 24-week HEP, respectively. The experimental group had an HEP adherence frequency of 4 (SD 2) to 5 (SD 2) times per week at 8 and 24 weeks (P=.14), whereas HEP adherence decreased in the control group from 4 (SD 2) to 3 (SD 2) times per week (P=.07), with a significant difference (P=.01) between groups at 24 weeks. Of the total participants, 68% (15/22) sent videos. They sent 68% (16/24) of the requested number of videos on average. The average score for PT care satisfaction was maintained at 87% in the experimental group (P=.99), whereas it decreased from 89% at 8 weeks to 74% at 24 weeks (P=.008) in the control group. App-related adverse events were not observed. Conclusions: The Hudl app/telehealth platform is feasible for delivering HEPs and maintaining HEP adherence in participants with chronic diseases who are experiencing financial distress. Trial Registration: ClinicalTrials.gov NCT02659280; https://clinicaltrials.gov/ct2/show/NCT02659280 UR - https://formative.jmir.org/2021/3/e22659 UR - http://dx.doi.org/10.2196/22659 UR - http://www.ncbi.nlm.nih.gov/pubmed/33640865 ID - info:doi/10.2196/22659 ER - TY - JOUR AU - van Buul, R. Amanda AU - Derksen, Caroline AU - Hoedemaker, Ouke AU - van Dijk, Oscar AU - Chavannes, H. Niels AU - Kasteleyn, J. Marise PY - 2021/3/18 TI - eHealth Program to Reduce Hospitalizations Due to Acute Exacerbation of Chronic Obstructive Pulmonary Disease: Retrospective Study JO - JMIR Form Res SP - e24726 VL - 5 IS - 3 KW - COPD KW - eHealth KW - exacerbations KW - hospitalizations KW - mHealth N2 - Background: Hospitalization for acute exacerbation of chronic obstructive pulmonary disease (COPD) is associated with poor prognosis. eHealth interventions might improve outcomes and decrease costs. Objective: This study aimed to evaluate the effect of an eHealth program on COPD hospitalizations and exacerbations. Methods: This was a real-world study conducted from April 2018 to December 2019 in the Bravis Hospital, the Netherlands. An eHealth program (EmmaCOPD) was offered to COPD patients at risk of exacerbations. EmmaCOPD consisted of an app that used questionnaires (to monitor symptoms) and a step counter (to monitor the number of steps) to detect exacerbations. Patients and their buddies received feedback when their symptoms worsened or the number of steps declined. Generalized estimating equations were used to compare the number of days admitted to the hospital and the total number of exacerbations 12 months before and (max) 18 months after the start of EmmaCOPD. We additionally adjusted for the potential confounders of age, sex, COPD severity, and inhaled corticosteroid use. Results: The 29 included patients had a mean forced expiratory volume in 1 second of 45.5 (SD 17.7) %predicted. In the year before the intervention, the median total number of exacerbations was 2.0 (IQR 2.0-3.0). The median number of hospitalized days was 8.0 days (IQR 6.0-16.5 days). Afterwards, there was a median 1.0 (IQR 0.0-2.0) exacerbation and 2.0 days (IQR 0.0-4.0 days) of hospitalization. After initiation of EmmaCOPD, both the number of hospitalized days and total number of exacerbations decreased significantly (incidence rate ratio 0.209, 95% CI 0.116-0.382; incidence rate ratio 0.310, 95% CI 0.219-0.438). Adjustment for confounders did not affect the results. Conclusions: The eHealth program seems to reduce the number of total exacerbations and number of days of hospitalization due to exacerbations of COPD. UR - https://formative.jmir.org/2021/3/e24726 UR - http://dx.doi.org/10.2196/24726 UR - http://www.ncbi.nlm.nih.gov/pubmed/33734091 ID - info:doi/10.2196/24726 ER - TY - JOUR AU - Smit, A. Marloes AU - van Pelt, W. Gabi AU - Dequeker, MC Elisabeth AU - Al Dieri, Raed AU - Tollenaar, AEM Rob AU - van Krieken, JM J. Han AU - Mesker, E. Wilma AU - PY - 2021/3/19 TI - e-Learning for Instruction and to Improve Reproducibility of Scoring Tumor-Stroma Ratio in Colon Carcinoma: Performance and Reproducibility Assessment in the UNITED Study JO - JMIR Form Res SP - e19408 VL - 5 IS - 3 KW - colon cancer KW - tumor-stroma ratio KW - validation KW - e-Learning KW - reproducibility study KW - cancer KW - tumor KW - colon KW - reproducibility KW - carcinoma KW - prognosis KW - diagnostic KW - implementation KW - online learning N2 - Background: The amount of stroma in the primary tumor is an important prognostic parameter. The tumor-stroma ratio (TSR) was previously validated by international research groups as a robust parameter with good interobserver agreement. Objective: The Uniform Noting for International Application of the Tumor-Stroma Ratio as an Easy Diagnostic Tool (UNITED) study was developed to bring the TSR to clinical implementation. As part of the study, an e-Learning module was constructed to confirm the reproducibility of scoring the TSR after proper instruction. Methods: The e-Learning module consists of an autoinstruction for TSR determination (instruction video or written protocol) and three sets of 40 cases (training, test, and repetition sets). Scoring the TSR is performed on hematoxylin and eosin?stained sections and takes only 1-2 minutes. Cases are considered stroma-low if the amount of stroma is ?50%, whereas a stroma-high case is defined as >50% stroma. Inter- and intraobserver agreements were determined based on the Cohen ? score after each set to evaluate the reproducibility. Results: Pathologists and pathology residents (N=63) with special interest in colorectal cancer participated in the e-Learning. Forty-nine participants started the e-Learning and 31 (63%) finished the whole cycle (3 sets). A significant improvement was observed from the training set to the test set; the median ? score improved from 0.72 to 0.77 (P=.002). Conclusions: e-Learning is an effective method to instruct pathologists and pathology residents for scoring the TSR. The reliability of scoring improved from the training to the test set and did not fall back with the repetition set, confirming the reproducibility of the TSR scoring method. Trial Registration: The Netherlands Trial Registry NTR7270; https://www.trialregister.nl/trial/7072 International Registered Report Identifier (IRRID): RR2-10.2196/13464 UR - https://formative.jmir.org/2021/3/e19408 UR - http://dx.doi.org/10.2196/19408 UR - http://www.ncbi.nlm.nih.gov/pubmed/33739293 ID - info:doi/10.2196/19408 ER - TY - JOUR AU - Teckie, Sewit AU - Solomon, Jeffrey AU - Kadapa, Karthik AU - Sanchez, Keisy AU - Orner, David AU - Kraus, Dennis AU - Kamdar, P. Dev AU - Pereira, Lucio AU - Frank, Douglas AU - Diefenbach, Michael PY - 2021/3/19 TI - A Mobile Patient-Facing App for Tracking Patient-Reported Outcomes in Head and Neck Cancer Survivors: Single-Arm Feasibility Study JO - JMIR Form Res SP - e24667 VL - 5 IS - 3 KW - mHealth KW - ePROs KW - head and neck cancer KW - mobile phone N2 - Background: Patients with head and neck cancer (HNC) frequently experience disease-related symptoms and treatment adverse effects that impact their overall quality of life. Cancer-specific mobile health apps for patient-related outcomes allow patients to communicate with their clinicians and proactively track their symptoms, which have been shown to improve clinical management and disease outcomes. Objective: The purpose of this study was to evaluate the feasibility of LogPAL, a novel iPhone-based mobile health app designed to help HNC survivors track and manage their posttreatment symptoms. Methods: Patients who completed curative treatment for HNC in the preceding 24 months were recruited from 2 clinical sites within a single institution. Upon enrollment, participants completed a brief sociodemographic survey, downloaded the app onto their iPhone devices, and were asked to complete a series of biweekly questionnaires (based on the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) via the app for an 8-week study period. The primary feasibility endpoints included retention (retaining >80% of the enrolled participants for the duration of the study period), adherence (>50% of the participants completing 100% of the questionnaires over the study period), and usability (a mean system usability scale [SUS] score >68). Additional postintervention questions were collected to assess perceived usefulness, acceptance, and overall satisfaction. Results: Between January and October 2019, 38 participants were enrolled in the study. Three participants dropped out, and 3 were classified as nonusers. The remaining 32 (87%) were eligible for analysis. Their mean age was 57.8 (SD 12.3) years (range 24-77 years, 81% [26/32] male). Overall, 375 of 512 (73.2%) questionnaires were completed, with 17 (53%) of the 32 participants adherent. Participant-reported usability was acceptable; the mean SUS score was 71.9 (95% CI 64.3-79.5) with high satisfaction of LogPAL usefulness and likelihood to recommend to other cancer survivors. Conclusions: This single-arm prospective pilot study showed that LogPAL is a feasible, regularly used, accepted app for HNC survivors, justifying a full-scale pilot. Based on the findings from this study, future iterations will aim to improve usability and test intervention efficacy. UR - https://formative.jmir.org/2021/3/e24667 UR - http://dx.doi.org/10.2196/24667 UR - http://www.ncbi.nlm.nih.gov/pubmed/33739291 ID - info:doi/10.2196/24667 ER - TY - JOUR AU - Li, H. Sophie AU - Graham, M. Bronwyn AU - Werner-Seidler, Aliza PY - 2021/3/23 TI - Gender Differences in Adolescent Sleep Disturbance and Treatment Response to Smartphone App?Delivered Cognitive Behavioral Therapy for Insomnia: Exploratory Study JO - JMIR Form Res SP - e22498 VL - 5 IS - 3 KW - insomnia KW - gender differences KW - adolescents KW - sleep disturbance KW - sleep quality KW - sleep KW - gender KW - digital interventions N2 - Background: Insomnia and sleep disturbance are pervasive and debilitating conditions affecting up to 40% of adolescents. Women and girls are at greater risk of insomnia, yet differences in treatment responsiveness between genders have not been adequately investigated. Additionally, while women report greater symptom severity and burden of illness than men, this discrepancy requires further examination in adolescents. Objective: The purpose of this study was to examine gender differences in sleep symptom profiles and treatment response in adolescents. Methods: Digital cognitive behavioral therapy for insomnia (CBT-I) treatment responsiveness, as indexed by changes in Insomnia Severity Index (ISI) and Global Pittsburgh Sleep Quality Index (PSQI) scores, was compared in boys and girls (aged 12-16 years; N=49) who participated in a pilot evaluation of the Sleep Ninja smartphone app. Gender differences in self-reported baseline insomnia symptom severity (ISI), sleep quality (PSQI), and sleep characteristics derived from sleep diaries were also examined. Results: Compared with boys, we found that girls reported greater symptom severity (P=.04) and nighttime wakefulness (P=.01 and P=.04) and reduced sleep duration (P=.02) and efficiency (P=.03), but not poorer sleep quality (P=.07), more nighttime awakenings (P=.16), or longer time to get to sleep (P=.21). However, gender differences in symptom severity and sleep duration were accounted for by boys being marginally younger in age. Treatment response to CBT-I was equivalent between boys and girls when comparing reductions in symptom severity (P=.32); there was a trend showing gender differences in improvements in sleep quality, but this was not statistically significant (P=.07). Conclusions: These results demonstrate the presence of gender differences in insomnia symptoms and severity in adolescents and suggest further research is required to understand gender differences in insomnia symptom profiles to inform the development of gender-specific digital interventions delivered to adolescents. UR - https://formative.jmir.org/2021/3/e22498 UR - http://dx.doi.org/10.2196/22498 UR - http://www.ncbi.nlm.nih.gov/pubmed/33755029 ID - info:doi/10.2196/22498 ER - TY - JOUR AU - Zucchelli, Fabio AU - Donnelly, Olivia AU - Rush, Emma AU - Smith, Harriet AU - Williamson, Heidi AU - PY - 2021/3/24 TI - Designing an mHealth Intervention for People With Visible Differences Based on Acceptance and Commitment Therapy: Participatory Study Gaining Stakeholders? Input JO - JMIR Form Res SP - e26355 VL - 5 IS - 3 KW - mobile health KW - acceptance and commitment therapy KW - appearance KW - qualitative KW - participatory design KW - mobile phone N2 - Background: Given their growing popularity, mobile health (mHealth) apps may offer a viable method of delivering psychological interventions for people with an atypical appearance (ie, visible difference) who struggle with appearance-related distress. Acceptance and Commitment Therapy (ACT), a third-wave cognitive behavioral approach, has been used effectively in mHealth and is being increasingly applied clinically to common psychosocial difficulties associated with visible differences. We planned to design an ACT-based mHealth intervention (ACT It Out) for this population. Objective: The aim of this study is to gain key stakeholder input from user representatives and psychological clinicians to optimize the intervention?s design for future development and uptake. To do so, we explored considerations relating to mHealth as a delivery platform for adults with visible differences and elicited stakeholders? design preferences and ideas based on initial author-created content. Methods: Within a participatory design framework, we used a mix of qualitative methods, including usability sessions and a focus group in a face-to-face workshop, and interviews and textual feedback collected remotely, all analyzed using template analysis. A total of 6 user representatives and 8 clinicians were recruited for this study. Results: Our findings suggest that there are likely to be strengths and challenges of mHealth as an intervention platform for the study population, with key concerns being user safeguarding and program adherence. Participants expressed design preferences toward relatable human content, interactive and actionable features, flexibility of use, accessibility, and engaging content. Conclusions: The findings offer valuable design directions for ACT It Out and related interventions, emphasizing the need to carefully guide users through the intervention while acknowledging the limited time and space that mHealth affords. UR - https://formative.jmir.org/2021/3/e26355 UR - http://dx.doi.org/10.2196/26355 UR - http://www.ncbi.nlm.nih.gov/pubmed/33759791 ID - info:doi/10.2196/26355 ER - TY - JOUR AU - Dopke, A. Cynthia AU - McBride, Alyssa AU - Babington, Pamela AU - Jonathan, K. Geneva AU - Michaels, Tania AU - Ryan, Chloe AU - Duffecy, Jennifer AU - Mohr, C. David AU - Goulding, H. Evan PY - 2021/3/24 TI - Development of Coaching Support for LiveWell: A Smartphone-Based Self-Management Intervention for Bipolar Disorder JO - JMIR Form Res SP - e25810 VL - 5 IS - 3 KW - human support KW - adherence KW - self-management KW - behavior change KW - mHealth KW - bipolar disorder UR - https://formative.jmir.org/2021/3/e25810 UR - http://dx.doi.org/10.2196/25810 UR - http://www.ncbi.nlm.nih.gov/pubmed/33759798 ID - info:doi/10.2196/25810 ER - TY - JOUR AU - Chi, Yuan AU - Velardo, Carmelo AU - Allen, Julie AU - Robinson, Stephanie AU - Riga, Evgenia AU - Judge, David AU - Tarassenko, Lionel AU - Farmer, J. Andrew PY - 2021/3/26 TI - System Architecture for "Support Through Mobile Messaging and Digital Health Technology for Diabetes" (SuMMiT-D): Design and Performance in Pilot and Randomized Controlled Feasibility Studies JO - JMIR Form Res SP - e18460 VL - 5 IS - 3 KW - type 2 diabetes KW - short message service KW - health-related behavior KW - mobile health KW - mHealth KW - mobile phone N2 - Background: Diabetes is a highly prevalent long-term condition with high morbidity and mortality rates. People with diabetes commonly worry about their diabetes medicines and do not always take them regularly as prescribed. This can lead to poor diabetes control. The Support Through Mobile Messaging and Digital Health Technology for Diabetes (SuMMiT-D) study aims to deliver brief messages as tailored interventions to support people with type 2 diabetes in better use of their diabetes medicines and to improve treatment adherence and health outcomes. Objective: This paper describes the overall architecture of a tailored intervention delivery system used in the pilot and randomized controlled feasibility studies of SuMMiT-D and reports its performance. Methods: The SuMMiT-D system includes several platforms and resources to recruit participants and deliver messages as tailored interventions. Its core component is called the clinical system and is responsible for interacting with the participants by receiving and sending SMS text messages from and to them. The personalization and tailoring of brief messages for each participant is based on a list of built-in commands that they can use. Results: For the pilot study, a total of 48 participants were recruited; they had a median age of 64 years (first quartile, third quartile [Q1, Q3: 54.5, 69]). For the feasibility study, a total of 209 participants were recruited and randomly assigned to either the control or intervention group; they had a median age of 65 years (Q1, Q3: 56, 71), with 41.1% (86/209) being female. The participants used the SuMMiT-D system for up to 6 months (26 weeks) and had a wide range of different interactions with the SuMMiT-D system while tailored interventions were being delivered. For both studies, we had low withdrawal rates: only 4.2% and 5.3% for the pilot and feasibility studies, respectively. Conclusions: A system was developed to successfully deliver brief messages as tailored health interventions to more than 250 people with type 2 diabetes via SMS text messages. On the basis of the low withdrawal rates and positive feedback received, it can be inferred that the SuMMiT-D system is robust, user-friendly, useful, and positive for most participants. From the two studies, we found that online recruitment was more efficient than recruitment via postal mail; a regular SMS text reminder (eg, every 4 weeks) can potentially increase the participants? interactions with the system. Trial Registration: ISRCTN Registry ISRCTN13404264; http://www.isrctn.com/ISRCTN13404264 UR - https://formative.jmir.org/2021/3/e18460 UR - http://dx.doi.org/10.2196/18460 UR - http://www.ncbi.nlm.nih.gov/pubmed/33769299 ID - info:doi/10.2196/18460 ER - TY - JOUR AU - Bente, Elise Britt AU - van 't Klooster, Roderick Jan Willem Jaap AU - Schreijer, Annemarie Maud AU - Berkemeier, Lea AU - van Gend, Elmar Joris AU - Slijkhuis, Hendrik Peter Jan AU - Kelders, Marion Saskia AU - van Gemert-Pijnen, Cornelia Julia Elisabeth Wilhelmina PY - 2021/3/26 TI - The Dutch COVID-19 Contact Tracing App (the CoronaMelder): Usability Study JO - JMIR Form Res SP - e27882 VL - 5 IS - 3 KW - usability testing KW - user evaluation KW - user experience KW - contact tracing apps KW - CoronaMelder KW - COVID-19 KW - pandemic KW - mobile apps KW - mHealth KW - public health N2 - Background: Adoption and evaluation of contact tracing tools based on information and communications technology may expand the reach and efficacy of traditional contact tracing methods in fighting COVID-19. The Dutch Ministry of Health, Welfare and Sports initiated and developed CoronaMelder, a COVID-19 contact tracing app. This app is based on a Google/Apple Exposure Notification approach and aims to combat the spread of the coronavirus among individuals by notifying those who are at increased risk of infection due to proximity to someone who later tests positive for COVID-19. The app should support traditional contact tracing by faster tracing and greater reach compared to regular contact tracing procedures. Objective: The main goal of this study is to investigate whether the CoronaMelder is able to support traditional contact tracing employed by public health authorities. To achieve this, usability tests were conducted to answer the following question: is the CoronaMelder user-friendly, understandable, reliable and credible, and inclusive? Methods: Participants (N=44) of different backgrounds were recruited: youth with varying educational levels, youth with an intellectual disability, migrants, adults (aged 40-64 years), and older adults (aged >65 years) via convenience sampling in the region of Twente in the Netherlands. The app was evaluated with scenario-based, think-aloud usability tests and additional interviews. Findings were recorded via voice recordings, observation notes, and the Dutch User Experience Questionnaire, and some participants wore eye trackers to measure gaze behavior. Results: Our results showed that the app is easy to use, although problems occurred with understandability and accessibility. Older adults and youth with a lower education level did not understand why or under what circumstances they would receive notifications, why they must share their key (ie, their assigned identifier), and what happens after sharing. In particular, youth in the lower-education category did not trust or understand Bluetooth signals, or comprehend timing and follow-up activities after a risk exposure notification. Older adults had difficulties multitasking (speaking with a public health worker and simultaneously sharing the key in the app). Public health authorities appeared to be unprepared to receive support from the app during traditional contact tracing because their telephone conversation protocol lacks guidance, explanation, and empathy. Conclusions: The study indicated that the CoronaMelder app is easy to use, but participants experienced misunderstandings about its functioning. The perceived lack of clarity led to misconceptions about the app, mostly regarding its usefulness and privacy-preserving mechanisms. Tailored and targeted communication through, for example, public campaigns or social media, is necessary to provide correct information about the app to residents in the Netherlands. Additionally, the app should be presented as part of the national coronavirus measures instead of as a stand-alone app offered to the public. Public health workers should be trained to effectively and empathetically instruct users on how to use the CoronaMelder app. UR - https://formative.jmir.org/2021/3/e27882 UR - http://dx.doi.org/10.2196/27882 UR - http://www.ncbi.nlm.nih.gov/pubmed/33724198 ID - info:doi/10.2196/27882 ER - TY - JOUR AU - Radu, Roxana AU - Hernández-Ortega, Sara AU - Borrega, Oriol AU - Palmeri, Avril AU - Athanasiou, Dimitrios AU - Brooke, Nicholas AU - Chapí, Inma AU - Le Corvec, Anaïs AU - Guglieri, Michela AU - Perera-Lluna, Alexandre AU - Garrido-Aguirre, Jon AU - Ryll, Bettina AU - Nafria Escalera, Begonya PY - 2021/3/29 TI - Global Collaborative Social Network (Share4Rare) to Promote Citizen Science in Rare Disease Research: Platform Development Study JO - JMIR Form Res SP - e22695 VL - 5 IS - 3 KW - Share4Rare KW - rare disease KW - citizen science KW - participatory medicine KW - natural history KW - genotype KW - phenotype N2 - Background: Rare disease communities are spread around the globe and segmented by their condition. Little research has been performed on the majority of rare diseases. Most patients who are affected by a rare disease have no research on their condition because of a lack of knowledge due to absence of common groups in the research community. Objective: We aimed to develop a safe and secure community of rare disease patients, without geographic or language barriers, to promote research. Methods: Cocreation design methodology was applied to build Share4Rare, with consultation and input through workshops from a variety of stakeholders (patients, caregivers, clinicians, and researchers). Results: The workshops allowed us to develop a layered version of the platform based on educating patients and caregivers with publicly accessible information, a secure community for the patients and caregivers, and a research section with the purpose of collecting patient information for analysis, which was the core and final value of the platform. Conclusions: Rare disease research requires global collaboration in which patients and caregivers have key roles. Collective intelligence methods implemented in digital platforms reduce geographic and language boundaries and involve patients in a unique and universal project. Their contributions are essential to increase the amount of scientific knowledge that experts have on rare diseases. Share4Rare has been designed as a global platform to facilitate the donation of clinical information to foster research that matters to patients with rare conditions. The codesign methods with patients have been essential to create a patient-centric design. UR - https://formative.jmir.org/2021/3/e22695 UR - http://dx.doi.org/10.2196/22695 UR - http://www.ncbi.nlm.nih.gov/pubmed/33779572 ID - info:doi/10.2196/22695 ER - TY - JOUR AU - van Noort, J. Esther M. AU - Claessens, Danny AU - Moor, C. Catharina AU - Berg, Den Carlijn A. L. Van AU - Kasteleyn, J. Marise AU - in 't Veen, M. Johannes C. C. AU - Van Schayck, P. Onno C. AU - Chavannes, H. Niels PY - 2021/3/31 TI - Online Tool for the Assessment of the Burden of COVID-19 in Patients: Development Study JO - JMIR Form Res SP - e22603 VL - 5 IS - 3 KW - COVID-19 KW - patient-reported outcomes KW - ABCoV tool KW - monitoring KW - patient outcome KW - long-term impact KW - tool KW - assessment KW - online patient platform N2 - Background: The impact of COVID-19 has been felt worldwide, yet we are still unsure about its full impact. One of the gaps in our current knowledge relates to the long-term mental and physical impact of the infection on affected individuals. The COVID-19 pandemic hit the Netherlands at the end of February 2020, resulting in over 900,000 people testing positive for the virus, over 24,000 hospitalizations, and over 13,000 deaths by the end of January 2021. Although many patients recover from the acute phase of the disease, experience with other virus outbreaks has raised concerns regarding possible late sequelae of the infection. Objective: This study aims to develop an online tool to assess the long-term burden of COVID-19 in patients. Methods: In this paper, we describe the process of development, assessment, programming, implementation, and use of this new tool: the assessment of burden of COVID-19 (ABCoV) tool. This new tool is based on the well-validated assessment of burden of chronic obstructive pulmonary disease tool. Results: As of January 2021, the new ABCoV tool has been used in an online patient platform by more than 2100 self-registered patients and another 400 patients in a hospital setting, resulting in over 2500 patients. These patients have submitted the ABCoV questionnaire 3926 times. Among the self-registered patients who agreed to have their data analyzed (n=1898), the number of females was high (n=1153, 60.7%), many were medically diagnosed with COVID-19 (n=892, 47.0%), and many were relatively young with only 7.4% (n=141) being older than 60 years. Of all patients that actually used the tool (n=1517), almost one-quarter (n=356, 23.5%) used the tool twice, and only a small group (n=76, 5.0%) used the tool 6 times. Conclusions: This new ABCoV tool has been broadly and repeatedly used, and may provide insight into the perceived burden of disease, provide direction for personalized aftercare for people post COVID-19, and help us to be prepared for possible future recurrences. UR - https://formative.jmir.org/2021/3/e22603 UR - http://dx.doi.org/10.2196/22603 UR - http://www.ncbi.nlm.nih.gov/pubmed/33729982 ID - info:doi/10.2196/22603 ER - TY - JOUR AU - Zeghari, Radia AU - König, Alexandra AU - Guerchouche, Rachid AU - Sharma, Garima AU - Joshi, Jyoti AU - Fabre, Roxane AU - Robert, Philippe AU - Manera, Valeria PY - 2021/3/31 TI - Correlations Between Facial Expressivity and Apathy in Elderly People With Neurocognitive Disorders: Exploratory Study JO - JMIR Form Res SP - e24727 VL - 5 IS - 3 KW - apathy KW - action units KW - assessment KW - ICT KW - facial video analysis KW - neurocognitive disorders KW - neurocognitive KW - facial analysis N2 - Background: Neurocognitive disorders are often accompanied by behavioral symptoms such as anxiety, depression, and/or apathy. These symptoms can occur very early in the disease progression and are often difficult to detect and quantify in nonspecialized clinical settings. Objective: We focus in this study on apathy, one of the most common and debilitating neuropsychiatric symptoms in neurocognitive disorders. Specifically, we investigated whether facial expressivity extracted through computer vision software correlates with the severity of apathy symptoms in elderly subjects with neurocognitive disorders. Methods: A total of 63 subjects (38 females and 25 males) with neurocognitive disorder participated in the study. Apathy was assessed using the Apathy Inventory (AI), a scale comprising 3 domains of apathy: loss of interest, loss of initiation, and emotional blunting. The higher the scale score, the more severe the apathy symptoms. Participants were asked to recall a positive and a negative event of their life, while their voice and face were recorded using a tablet device. Action units (AUs), which are basic facial movements, were extracted using OpenFace 2.0. A total of 17 AUs (intensity and presence) for each frame of the video were extracted in both positive and negative storytelling. Average intensity and frequency of AU activation were calculated for each participant in each video. Partial correlations (controlling for the level of depression and cognitive impairment) were performed between these indexes and AI subscales. Results: Results showed that AU intensity and frequency were negatively correlated with apathy scale scores, in particular with the emotional blunting component. The more severe the apathy symptoms, the less expressivity in specific emotional and nonemotional AUs was displayed from participants while recalling an emotional event. Different AUs showed significant correlations depending on the sex of the participant and the task?s valence (positive vs negative story), suggesting the importance of assessing male and female participants independently. Conclusions: Our study suggests the interest of employing computer vision-based facial analysis to quantify facial expressivity and assess the severity of apathy symptoms in subjects with neurocognitive disorders. This may represent a useful tool for a preliminary apathy assessment in nonspecialized settings and could be used to complement classical clinical scales. Future studies including larger samples should confirm the clinical relevance of this kind of instrument. UR - https://formative.jmir.org/2021/3/e24727 UR - http://dx.doi.org/10.2196/24727 UR - http://www.ncbi.nlm.nih.gov/pubmed/33787499 ID - info:doi/10.2196/24727 ER - TY - JOUR AU - Godfrey, M. Emily AU - Kazmerski, M. Traci AU - Brown, Georgia AU - Thayer, K. Erin AU - Mentch, Laura AU - Pam, Molly AU - Al Achkar, Morhaf PY - 2021/3/4 TI - Educational Needs and Preferences for Patient-Centered Outcomes Research in the Cystic Fibrosis Community: Mixed Methods Study JO - JMIR Form Res SP - e24302 VL - 5 IS - 3 KW - cystic fibrosis KW - needs assessment KW - patient-centered outcomes research KW - training KW - education KW - team building KW - patient engagement N2 - Background: Cystic fibrosis (CF) is a rare, life-shortening, multiorgan disease, the treatment of which has seen significant increases in the life expectancy of those with CF. Many advances in CF care are thanks to the dedicated and active participation of people with CF as research participants. Unfortunately, most CF research teams still do not fully partner with people with CF or their caregivers. Objective: The aim of this study was to determine the interest, knowledge gaps, and desired format for patient-centered outcomes research (PCOR) training in the CF community. Methods: We surveyed patients, caregivers, researchers, research staff, and diverse health care providers via list servers and social media outreach about their knowledge of, experience with, and preferences for PCOR training components. We followed the survey with 3 small-group discussion sessions with 22 participants who completed the survey to establish consensus and prioritize key learning components of a PCOR training program. We summarized results using descriptive statistics. Results: A total of 170 participants completed the survey (patients/caregivers: 96/170, 56.5%; researchers/health care providers: 74/170, 43.5%). Among providers, 26% (19/74) were physicians/advanced practice providers, 20% (15/74) were nurses, and 54% (40/74) were from other disciplines. Among all participants, 86.5% (147/170) expressed interest in learning about PCOR, although training topics and training format differed between the patient/caregiver and researcher/health care provider groups. Before participating in PCOR, patients/caregivers wanted to understand more about expectations of them as partners on PCOR research teams (82/96, 85%). Meanwhile, researchers/health care providers desired information on how to include outcomes important to patients/caregivers (55/74, 74%) and the quality and impact of PCOR research (52/74, 70% and 51/74, 69%, respectively). Patients/caregivers were most interested in learning about the time commitment as a PCOR team member (75/96, 78%). Researchers/health care providers wanted to receive training about how to establish trust (47/74, 64%) and maintain confidentiality (47/74, 64%) when including patient or caregiver partners on the PCOR team. During follow-up discussions, participants emphasized the importance of addressing the traditional patient/caregiver and researchers/health care provider hierarchy by teaching about transparency, appreciation, creating a common language between the groups, and providing specific training on ?how? to do PCOR. Conclusions: Our findings suggest CF community members are interested in PCOR. A high-quality training program would fill a current deficit in methodological research. This assessment identified the topics and formats desired and can be used to develop targeted training to enhance meaningful PCOR in CF. UR - https://formative.jmir.org/2021/3/e24302 UR - http://dx.doi.org/10.2196/24302 UR - http://www.ncbi.nlm.nih.gov/pubmed/33661127 ID - info:doi/10.2196/24302 ER - TY - JOUR AU - Mira, Joaquin Jose AU - Cobos, Angel AU - Martínez García, Olga AU - Bueno Domínguez, José María AU - Astier-Peña, Pilar María AU - Pérez Pérez, Pastora AU - Carrillo, Irene AU - Guilabert, Mercedes AU - Perez-Jover, Virtudes AU - Fernandez, Cesar AU - Vicente, Asuncion María AU - Lahera-Martin, Matilde AU - Silvestre Busto, Carmen AU - Lorenzo Martínez, Susana AU - Sanchez Martinez, Ascension AU - Martin-Delgado, Jimmy AU - Mula, Aurora AU - Marco-Gomez, Barbara AU - Abad Bouzan, Cristina AU - Aibar-Remon, Carlos AU - Aranaz-Andres, Jesus AU - PY - 2021/3/9 TI - An Acute Stress Scale for Health Care Professionals Caring for Patients With COVID-19: Validation Study JO - JMIR Form Res SP - e27107 VL - 5 IS - 3 KW - SARS-CoV-2 virus KW - COVID-19 outbreak KW - medical staff KW - acute stress KW - moral injury KW - posttraumatic stress KW - COVID-19 N2 - Background: The COVID-19 pandemic has affected the response capacity of the health care workforce, and health care professionals have been experiencing acute stress reactions since the beginning of the pandemic. In Spain, the first wave was particularly severe among the population and health care professionals, many of whom were infected. These professionals required initial psychological supports that were gradual and in line with their conditions. Objective: In the early days of the pandemic in Spain (March 2020), this study aimed to design and validate a scale to measure acute stress experienced by the health care workforce during the care of patients with COVID-19: the Self-applied Acute Stress Scale (EASE). Methods: Item development, scale development, and scale evaluation were considered. Qualitative research was conducted to produce the initial pool of items, assure their legibility, and assess the validity of the content. Internal consistency was calculated using Cronbach ? and McDonald ?. Confirmatory factor analysis and the Mann-Whitney-Wilcoxon test were used to assess construct validity. Linear regression was applied to assess criterion validity. Back-translation methodology was used to translate the scale into Portuguese and English. Results: A total of 228 health professionals from the Spanish public health system responded to the 10 items of the EASE scale. Internal consistency was .87 (McDonald ?). Goodness-of-fit indices confirmed a two-factor structure, explaining 55% of the variance. As expected, the highest level of stress was found among professionals working in health services where a higher number of deaths from COVID-19 occurred (P<.05). Conclusions: The EASE scale was shown to have adequate metric properties regarding consistency and construct validity. The EASE scale could be used to determine the levels of acute stress among the health care workforce in order to give them proportional support according to their needs during emergency conditions, such as the COVID-19 pandemic. UR - https://formative.jmir.org/2021/3/e27107 UR - http://dx.doi.org/10.2196/27107 UR - http://www.ncbi.nlm.nih.gov/pubmed/33687343 ID - info:doi/10.2196/27107 ER - TY - JOUR AU - Ferris, B. Emily AU - Wyka, Katarzyna AU - Evenson, R. Kelly AU - Dorn, M. Joan AU - Thorpe, Lorna AU - Catellier, Diane AU - Huang, T-K Terry PY - 2021/3/24 TI - Recruitment and Retention Strategies for Community-Based Longitudinal Studies in Diverse Urban Neighborhoods JO - JMIR Form Res SP - e18591 VL - 5 IS - 3 KW - community-based KW - participant engagement KW - natural experiment KW - built environment intervention KW - health disparities KW - study adaptations UR - https://formative.jmir.org/2021/3/e18591 UR - http://dx.doi.org/10.2196/18591 UR - http://www.ncbi.nlm.nih.gov/pubmed/33759799 ID - info:doi/10.2196/18591 ER - TY - JOUR AU - Bonet Olivencia, Samuel AU - Sasangohar, Farzan PY - 2021/3/4 TI - Investigating the Food and Drug Administration Biotherapeutics Review and Approval Process: Narrative Review JO - JMIR Form Res SP - e14563 VL - 5 IS - 3 KW - biotherapeutics KW - drug approval KW - drug review process KW - model-based systems engineering N2 - Background: The development, review, and approval process of therapeutic biological products in the United States presents two primary challenges: time and cost. Advancing a biotherapeutic from concept to market may take an average of 12 years, with costs exceeding US $1 billion, and the product may still fail the US Food and Drug Administration (FDA) approval process. Despite the FDA?s practices to expedite the approval of new therapies, seeking FDA approval remains a long, costly, and risky process. Objective: The objective of this paper is to explore the factors and gaps related to the FDA review and approval process that contribute to process inefficiencies and complexities as well as proposed methods and solutions to address such gaps. This paper also aims to investigate the available modeling efforts for the FDA approval process of therapeutic biological products. Methods: A narrative review of literature was conducted to understand the scope of published knowledge about challenges, opportunities, and specific methods to address the factors and gaps related to the review and approval of new drugs, including therapeutic biological products. Relevant peer-reviewed journal articles, conference proceedings, book chapters, official reports from public policy professional centers, and official reports and guidelines from the FDA were reviewed. Results: Of the 23 articles identified in this narrative literature review, none modeled the current FDA review and approval process structure to address issues related to the robustness, reliability, and efficiency of its operations from an external point of view. Although several studies summarize the FDA approval process with clarity, in addition to bringing to light the problems and challenges faced by the regulatory agency, only a few attempts have been made to provide solutions for the problems and challenges identified. In addition, although several reform models have been discussed, these models lack the application of scientific methodologies and modeling techniques in understanding FDA as a complex sociotechnical system. Furthermore, tools and methods to assess the efficacy of the models before implementation are largely absent. Conclusions: The findings suggest the efficacy of model-based systems engineering approaches for identifying opportunities for significant improvements to the FDA review and approval process. Using this holistic approach will serve several investigative purposes: identify influential sources of variability that cause major delays, including individual, team, and organizational decision making; identify the human-system bottlenecks; identify areas of opportunity for design-driven improvements; study the effect of induced changes in the system; and assess the robustness of the structure of the FDA approval process in terms of enforcement and information symmetry. UR - https://formative.jmir.org/2021/3/e14563 UR - http://dx.doi.org/10.2196/14563 UR - http://www.ncbi.nlm.nih.gov/pubmed/33661119 ID - info:doi/10.2196/14563 ER - TY - JOUR AU - Zegers, L. Catharina M. AU - Witteveen, Annemieke AU - Schulte, J. Mieke H. AU - Henrich, F. Julia AU - Vermeij, Anouk AU - Klever, Brigit AU - Dekker, Andre PY - 2021/3/17 TI - Mind Your Data: Privacy and Legal Matters in eHealth JO - JMIR Form Res SP - e17456 VL - 5 IS - 3 KW - data KW - privacy KW - eHealth UR - https://formative.jmir.org/2021/3/e17456 UR - http://dx.doi.org/10.2196/17456 UR - http://www.ncbi.nlm.nih.gov/pubmed/33729163 ID - info:doi/10.2196/17456 ER - TY - JOUR AU - Mussetti, Alberto AU - Salas, Queralt Maria AU - Condom, Maria AU - Antonio, Maite AU - Ochoa, Cristian AU - Ivan, Iulia AU - Jimenez Ruiz-De la Torre, David AU - Sanz Linares, Gabriela AU - Ansoleaga, Belen AU - Patiño-Gutierrez, Beatriz AU - Jimenez-Prat, Laura AU - Parody, Rocio AU - Sureda-Balari, Ana PY - 2021/3/12 TI - Use of Telehealth for Domiciliary Follow-up After Hematopoietic Cell Transplantation During the COVID-19 Pandemic: Prospective Pilot Study JO - JMIR Form Res SP - e26121 VL - 5 IS - 3 KW - SARS-CoV-2 KW - COVID-19 KW - hematology KW - hematopoietic cell transplantation KW - telemedicine KW - mortality KW - surveillance KW - monitoring KW - stem cell KW - transplant KW - app KW - medical device N2 - Background: Patients who have recently received a hematopoietic cell transplant (HCT) are at higher risk of acute complications in the first weeks after discharge, especially during the COVID-19 pandemic. Objective: The aim of this study was to test the use of a telehealth platform for the follow-up of HCT patients during the first two weeks after discharge. Methods: In total, 21 patients who received autologous or allogeneic HCT for hematological malignancies were screened from April 30, 2020, to July 15, 2020. The telehealth platform assisted in the daily collection of vital signs as well as physical and psychological symptoms for two weeks after hospital discharge. The required medical devices (oximeter and blood pressure monitor) were given to patients and a dedicated smartphone app was developed to collect this data. The data were reviewed daily through web-based software by a hematologist specializing in HCT. Results: Only 12 of 21 patients were able to join and complete the study. Technological barriers were the most frequent limiting factor in this study. Among the 12 patients who completed the study, adherence to data reporting was high. The patients? experience of using such a system was considered good. In two cases, the system enabled the early recognition of acute complications. Conclusions: This pilot study showed that telehealth systems can be applied in the early posttransplant setting, with evident advantages for physicians and patients for both medical and psychological aspects. Technological issues still represent a challenge for the applicability of such a system, especially for older adult patients. Easier-to-use technologies could help to expand the use of telehealth systems in this setting in the future. UR - https://formative.jmir.org/2021/3/e26121 UR - http://dx.doi.org/10.2196/26121 UR - http://www.ncbi.nlm.nih.gov/pubmed/33600351 ID - info:doi/10.2196/26121 ER - TY - JOUR AU - Ngoc Cong Duong, Khanh AU - Nguyen Le Bao, Tien AU - Thi Lan Nguyen, Phuong AU - Vo Van, Thanh AU - Phung Lam, Toi AU - Pham Gia, Anh AU - Anuratpanich, Luerat AU - Vo Van, Bay PY - 2021/3/5 TI - Correction: Psychological Impacts of COVID-19 During the First Nationwide Lockdown in Vietnam: Web-Based, Cross-Sectional Survey Study JO - JMIR Form Res SP - e28357 VL - 5 IS - 3 UR - https://formative.jmir.org/2021/3/e28357 UR - http://dx.doi.org/10.2196/28357 UR - http://www.ncbi.nlm.nih.gov/pubmed/33667175 ID - info:doi/10.2196/28357 ER -