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Journal Description

JMIR Formative Research (JFR) (a PubMed-indexed sister journal of J Med Internet Res (JMIR) and JMIR mHealth & uHealth, the leading eHealth and mHealth journals by impact factor) publishes peer-reviewed, openly accessible papers containing results from process evaluations, feasibility/pilot studies and other kinds of formative research and preliminary results. While the original focus was on the design of medical and health-related research and technology innovations, JFR publishes studies from all areas of medical and health research.

Formative research is research that occurs before a program is designed and implemented, or while a program is being conducted. Formative research can help

  • define and understand populations in need of a intervention or public health program
  • create programs that are specific to the needs of those populations
  • ensure programs are acceptable and feasible to users before launching
  • improve the relationship between users and agencies/research groups
  • demonstrate the feasibility, use, satisfaction with, or problems with a program before large-scale summative evaluation (looking at health outcomes)

Many funding agencies will expect some sort of pilot/feasibility/process evaluation before funding a larger study such as a Randomized Controlled Trial (RCT).

Formative research should be an integral part of developing programs or adapting programs, and should be used while the program is on-going to help refine and improve program activities. Thus, formative evaluation can and should also occur in form of a process evaluation alongside a summative evaluation such as a RCT.

This journal fills an important gap in the academic journals landscape, as it publishes sound and peer-reviewed formative research that is criticial for investigators to apply for further funding, but that is usually not published in outcomes-focussed medical journals aiming for impact and generalizability.

Summative evaluations of programs and apps/software that have undergone a thorough formative evaluation before launch have a better chance to be published in our high-impact flagship journals (JMIR mHealth, J Med Internet Res, JMIR Serious Games), thus we encourage authors to submit - as a first step - their formative evaluations in JMIR Formative Res (and their evaluation protocols in JMIR Res Protoc). 

JMIR Formative Res has been accepted for indexing in PubMed and PubMed Central.

 

Recent Articles:

  • Source: Pxhere; Copyright: rawpixel.com; URL: https://pxhere.com/en/photo/1574137; License: Public Domain (CC0).

    Treatment Preferences for Internet-Based Cognitive Behavioral Therapy for Insomnia in Japan: Online Survey

    Abstract:

    Background: The internet has the potential to increase individuals’ access to cognitive behavioral therapy (CBT) for insomnia at low cost. However, treatment preferences regarding internet-based computerized CBT for insomnia have not been fully examined. Objective: The aim was to conduct an anonymous online survey to evaluate treatment preferences for insomnia among patients with insomnia and individuals without insomnia. Methods: We developed an online survey to recruit a total of 600 participants living in the Kanto district in Japan. There were three subgroups: 200 medicated individuals with insomnia, 200 unmedicated individuals with insomnia, and 200 individuals without insomnia. The survey asked questions about the severity of the respondent’s insomnia (using the Athens Insomnia Scale), the frequency of sleep medication use and the level of satisfaction with sleep medication use, the respondent’s knowledge of CBT, his or her preference for CBT for insomnia before drug therapy, preference for CBT versus drug therapy, and preference for internet-based CBT versus face-to-face CBT. Results: Of the 600 respondents, 47.7% (286/600) indicated that they received CBT before drug therapy, and 57.2% (343/600) preferred CBT for insomnia to drug therapy. In addition, 47.0% (282/600) preferred internet-based CBT for insomnia to face-to-face CBT. Although the respondents with insomnia who were taking an insomnia medication had a relatively lower preference for internet-based CBT (40.5%, 81/200), the respondents with insomnia who were not taking an insomnia medication had a relatively higher preference for internet-based CBT (55.5%, 111/200). Conclusions: The results of our online survey suggest that approximately half of the people queried preferred CBT for insomnia to drug therapy, and half of the respondents preferred internet-based CBT for insomnia to face-to-face CBT.

  • Source: Unsplash; Copyright: Matt Wildbore; URL: https://unsplash.com/photos/wF14k8SyGzA; License: Licensed by JMIR.

    Internet-Based Cognitive Therapy for Social Anxiety Disorder in Hong Kong: Therapist Training and Dissemination Case Series

    Abstract:

    Background: Guided internet-based psychological interventions show substantial promise for expanding access to evidence-based mental health care. However, this can only be achieved if results of tightly controlled studies from the treatment developers can also be achieved in other independent settings. This dissemination depends critically on developing efficient and effective ways to train professionals to deliver these interventions. Unfortunately, descriptions of therapist training and its evaluation are often limited or absent within dissemination studies. Objective: This study aimed to describe and evaluate a program of therapist training to deliver internet-based Cognitive Therapy for social anxiety disorder (iCT-SAD). As this treatment was developed in the United Kingdom and this study was conducted in Hong Kong with local therapists, an additional objective was to examine the feasibility, acceptability, and initial efficacy of iCT-SAD in this cultural context, based on data from a pilot case series. Methods: Training in iCT-SAD was provided to 3 therapists and included practice of the face-to-face format of therapy under clinical supervision, training workshops, and treating 6 patients with the iCT-SAD program. Training progress was evaluated using standardized and self-report measures and by reviewing patient outcomes. In addition, feedback from patients and therapists was sought regarding the feasibility and acceptability of the program. Results: The training program was effective at increasing therapists’ iCT-SAD knowledge and skills, resulting in levels of competence expected of a specialist Cognitive Behavioral Therapy practitioner. The 6 patients treated by the trainees all completed their treatment and achieved a mean pre- to posttreatment change of 53.8 points (SD 39.5) on the primary patient outcome measure, the Liebowitz Social Anxiety Scale. The within-group effect size (Cohen d) was 2.06 (95% CI 0.66-3.46). There was evidence to suggest that the patients’ clinical outcomes were sustained at 3-month follow-up. These clinical results are comparable to those achieved by UK patients treated by the developers of the internet program. Patient and therapist feedback did not identify any major cultural barriers to implementing iCT-SAD in Hong Kong; some modest language suggestions were made to assist understanding. Conclusions: The therapist training implemented here facilitated the successful dissemination of an effective UK-developed internet intervention to Hong Kong. The treatment appeared feasible and acceptable in this setting and showed highly promising initial efficacy. A randomized controlled trial is now required to examine this more robustly. As therapist training is critical to the successful dissemination of internet interventions, further research to develop, describe, and evaluate therapist training procedures is recommended.

  • Source: Flickr; Copyright: Marco Verch; URL: https://www.flickr.com/photos/30478819@N08/42778819260/; License: Creative Commons Attribution (CC-BY).

    Feasibility and Acceptability of Using a Mobile Phone App for Characterizing Auditory Verbal Hallucinations in Adolescents With Early-Onset Psychosis:...

    Abstract:

    Background: Auditory verbal hallucinations (AVH) are the most frequent symptom in early-onset psychosis (EOP) and a risk factor for increased suicide attempts in adolescents. Increased knowledge of AVH characteristics can lead to better prediction of risk and precision of diagnosis and help identify individuals with AVH who need care. As 98% of Norwegian adolescents aged 12 to 16 years own a mobile phone, the use of mobile phone apps in symptom assessment and patient communication is a promising new tool. However, when introducing new technology to patients, their subjective experiences are crucial in identifying risks, further development, and potential integration into clinical care. Objective: The objective was to explore the feasibility and acceptability of a newly developed mobile phone app in adolescents with EOP by examining compliance with the app and user experiences. Indication of validity was explored by examining associations between AVH dimensions, which were correlated and analyzed. Methods: Three adolescents with EOP and active AVH were enrolled. Real-time AVH were logged on an iPod touch using the experience sampling method (ESM), for seven or more consecutive days. The app included five dimensions of AVH characteristics and was programmed with five daily notifications. Feasibility and acceptability were examined using the mean response rate of data sampling and by interviewing the participants. Validity was assessed by examining associations between the AVH dimensions using nonparametric correlation analysis and by visual inspection of temporal fluctuations of the AVH dimensions. Results: One participant was excluded from the statistical analyses but completed the interview and was included in the examination of acceptability. The sampling period of the two participants was mean 12 (SD 6) days with overall completed sampling rate of 74% (SD 30%), indicating adequate to high compliance with the procedure. The user experiences from the interviews clustered into four categories: (1) increased awareness, (2) personal privacy, (3) design and procedure, and (4) usefulness and clinical care. One participant experienced more commenting voices during the sampling period, and all three participants had concerns regarding personal privacy when using electronic devices in symptom assessment. The AVH dimensions of content, control, and influence showed moderate to strong significant correlations with all dimensions (P<.001). Days of data sampling showed weak to moderate correlations with localization (P<.001) and influence (P=.03). Visual inspection indicated that the app was able to capture fluctuations within and across days for all AVH dimensions. Conclusions: This study demonstrates the value of including patients’ experiences in the development and pilot-testing of new technology. Based on the small sample size, the use of mobile phones with ESM seems feasible for patients with EOP, but the acceptability of using apps should be considered. Further investigation with larger samples is warranted before definitive conclusions are made.

  • Source: The Authors / Placeit; Copyright: JMIR Publications; URL: http://formative.jmir.org/2019/2/e13324/; License: Creative Commons Attribution (CC-BY).

    Young Adults’ Engagement With a Self-Monitoring App for Vegetable Intake and the Impact of Social Media and Gamification: Feasibility Study

    Abstract:

    Background: Social media and gamification have been used in digital interventions for improving nutrition behaviors of young adults, but few studies measure engagement. Objective: This feasibility study aimed to explore user engagement with a 4-week smartphone program for improving vegetable intake. Methods: A goal setting and self-monitoring app was developed for feasibility testing. We assessed if additional components of gaming and/or social media support increased engagement. A 2 × 2 factorial study design was used with participants randomly allocated to each group. Engagement with the app (usage) was captured via inbuilt software, which recorded total days of app usage (duration) and the frequency of logging vegetable intake. Uptake of the social media (Facebook) content was measured by tracking views, likes, and comments on posts. Results: Out of the 110 potential participants who completed the prescreening questionnaire online, 97 were eligible (mean age 24.8 [SD 3.4]). In total, 49% (47/97) of participants were retained at 4 weeks. Attrition within the first week was the highest among users of the gamified app without social support (Facebook; P<.001). Over the intervention period, 64% (62/97) of participants logged into their app, with vegetable intake recorded on average for 11 out of 28 days. The frequency of recording decreased each week (mean 4 [SD 2] days in week 1 versus mean 2 [SD 2] days in week 4). No effects of gaming or social support on the frequency of recording vegetables or the duration of app engagement were found. However, regardless of the app type, the duration of app engagement was significantly associated with vegetable intake post intervention (P<.001). In total, 60% of Facebook posts were viewed by participants but engagement was limited to likes, with no comments or peer-to-peer interaction observed. Conclusions: As duration of usage was associated with vegetable intake, a deeper understanding of factors influencing engagement is needed. Dimensions such as personal attributes and the setting and context require further exploration in addition to content and delivery.

  • Source: The Authors / Placeit; Copyright: The Authors; URL: http://formative.jmir.org/2019/2/e12132/; License: Creative Commons Attribution (CC-BY).

    An E-Learning Adaptation of an Evidence-Based Media Literacy Curriculum to Prevent Youth Substance Use in Community Groups: Development and Feasibility of...

    Abstract:

    Background: There is a need for evidence-based substance use prevention efforts that target high school-aged youth that are easy to implement and suitable for dissemination in school and community groups. The Youth Message Development (YMD) program is a brief, four-lesson, in-person curriculum that aims to prevent youth substance use through the development of youth media literacy. Specifically, YMD aims to increase understanding of advertising reach and costs, along with the techniques used to sell products; develop counterarguing and critical thinking skills in response to advertisements; and facilitate application of these skills to the development of youth-generated antisubstance messages. Although YMD has demonstrated evidence of success, it is limited by its delivery method and focus on alcohol and smoking. Objective: Study objectives were two-fold: (1) to adapt the YMD curriculum to a self-paced, interactive, electronic-learning (e-learning) format and expand its content to cover alcohol, combustible cigarettes, e-cigarettes, smokeless tobacco, marijuana, and prescription drugs, and (2) to test the feasibility of the adapted curriculum in partnership with a national youth organization. Methods: An iterative process was employed in partnership with the 4-H youth development organization and a technology developer and consisted of six phases: (1) focus groups to guide adaptation, (2) adaptation to an e-learning format renamed REAL media, (3) pilot-testing of the REAL media prototype to determine feasibility and acceptability, (4) program revisions, (5) usability testing of the revised prototype, and (6) final revisions. Focus groups and pilot and usability testing were conducted with 4-H youth club members and adult club leaders. Results: Focus group feedback guided the build of an e-learning prototype of REAL media, which consisted of five online levels and interactive content guided by a mix of narration and on-screen text. Results of a pilot test of the prototype were neutral to positive, and the program was refined based on end-user feedback. An independent usability test indicated that youth 4-H members felt favorably about navigating REAL media, and they reported high self-efficacy in applying skills learned in the program. Additional refinements to the program were made based on their feedback. Conclusions: The iterative build process involving the end user from the outset yielded an overall successful technology-driven adaptation of an evidence-based curriculum. This should increase the likelihood of effectively impacting behavioral outcomes as well as uptake within community organizations.

  • Source: The Authors / Placeit; Copyright: The Authors; URL: http://formative.jmir.org/2019/2/e11890/; License: Creative Commons Attribution (CC-BY).

    Barriers and Facilitators for Implementing a Decision Support System to Prevent and Treat Disease-Related Malnutrition in a Hospital Setting: Qualitative Study

    Abstract:

    Background: Disease-related malnutrition is a challenge among hospitalized patients. Despite guidelines and recommendations for prevention and treatment, the condition continues to be prevalent. The MyFood system is a recently developed decision support system to prevent and treat disease-related malnutrition. Objective: To investigate the possible implementation of the MyFood system in clinical practice, the aims of the study were (1) to identify current practice, routines, barriers, and facilitators of nutritional care; (2) to identify potential barriers and facilitators for the use of MyFood; and (3) to identify the key aspects of an implementation plan. Methods: A qualitative study was performed among nurses, physicians, registered dietitians, and middle managers in 2 departments in a university hospital in Norway. Focus group discussions and semistructured interviews were used to collect data. The Consolidated Framework for Implementation Research (CFIR) was used to create the interview guide and analyze the results. The transcripts were analyzed using a thematic analysis. Results: A total of 27 health care professionals participated in the interviews and focus groups, including nurses (n=20), physicians (n=2), registered dietitians (n=2), and middle managers (n=3). The data were analyzed within 22 of the 39 CFIR constructs. Using the 5 CFIR domains as themes, we obtained the following results: (1) Intervention characteristics: MyFood was perceived to have a relative advantage of being more trustworthy, systematic, and motivational and providing increased awareness of nutritional treatment compared with the current practice. Its lack of communication with the existing digital systems was perceived as a potential barrier; (2) Outer settings: patients from different cultural backgrounds with language barriers and of older age were potential barriers for the use of the MyFood system; (3) Inner settings: no culture for specific routines or systems related to nutritional care existed in the departments. However, tension for change regarding screening for malnutrition risk, monitoring and nutritional treatment was highlighted in all categories of interviewees; (4) Characteristics of the individuals: positive attitudes toward MyFood were present among the majority of the interviewees, and they expressed self-efficacy toward the perceived use of MyFood; (5) Process: providing sufficient information to everyone in the department was highlighted as key to the success of the implementation. The involvement of opinion leaders, implementation leaders, and champions was also suggested for the implementation plan. Conclusions: This study identified several challenges in the nutritional care of hospitalized patients at risk of malnutrition and deviations from recommendations and guidelines. The MyFood system was perceived as being more precise, trustworthy, and motivational than the current practice. However, several potential barriers were identified. The assessment of the current situation and the identification of perceived barriers and facilitators will be used in planning an implementation and effect study, including the creation of an implementation plan.

  • Source: The Authors / Placeit; Copyright: JMIR Publications; URL: http://formative.jmir.org/2019/2/e11364/; License: Creative Commons Attribution (CC-BY).

    The Use of Smart Technology in an Online Community of Patients With Degenerative Cervical Myelopathy

    Abstract:

    Background: Degenerative cervical myelopathy (DCM) is a prevalent and progressively disabling neurological condition. Treatment is currently limited to surgery, the timing of which is not without controversy. New international guidelines recommend that all patients should undergo lifelong surveillance and those with moderate-to-severe or progressive disease should be offered surgery. Long-term surveillance will place substantial burden on health services and short clinic assessments may risk misrepresenting disease severity. The use of smart technology to monitor disease progression could provide an invaluable opportunity to lessen this burden and improve patient care. However, given the older demographic of DCM, the feasibility of smart technology use is unclear. Objective: The aim of this study was to investigate current usage of smart technology in patients with self-reported DCM to inform design of smart technology apps targeted at monitoring DCM disease progression. Methods: Google Analytics from the patient section of Myelopathy.org, an international DCM charity with a large online patient community, was analyzed over a 1-year period. A total of 15,761 sessions were analyzed. Results: In total, 39.6% (295/744) of visitors accessed the website using a desktop computer, 35.1% (261/744) using mobile, and 25.3% (188/744) using a tablet. Of the mobile and tablet visitors, 98.2% (441/449) utilized a touchscreen device. A total of 51.3% (141/275) of mobile and tablet visitors used iPhone Operating System (iOS) and 45.8% (126/275) used an Android operating system. Apple and Samsung were the most popular smart devices, utilized by 53.6% (241/449) and 25.8% (116/449) of visitors, respectively. The overall visitor age was representative of DCM trials. Smart technology was widely used by older visitors: 58.8% (113/192) of mobile visitors and 84.2% (96/114) of tablet visitors were aged 45 years or older. Conclusions: Smart technology is commonly used by DCM patients. DCM apps need to be iOS and Android compatible to be accessible to all patients.

  • Source: The Authors / Placeit; Copyright: JMIR Publications; URL: http://formative.jmir.org/2019/2/e12679/; License: Creative Commons Attribution (CC-BY).

    Feasibility of a Mobile Phone App to Promote Adherence to a Heart-Healthy Lifestyle: Single-Arm Study

    Abstract:

    Background: Long-term maintenance of preventive activities is fundamental for achieving improved outcomes in cardiac rehabilitation (CR). Despite this, it has been shown to be a major challenge for many patients to follow recommendations and thereby adhere to a heart-healthy lifestyle. Mobile phone apps have been emphasized as potential tools to promote preventive activities after attendance in a CR program. Before commencing a trial to assess the potential effect of using an app to promote long-term adherence to preventive activities after attendance in CR, a study to assess if it is feasible to use an app is warranted. Objective: The goal of the research is to assess if it is feasible to use a mobile phone app for promoting and monitoring patients’ adherence to a heart-healthy lifestyle after CR. Methods: The study included an experimental, pre-post single-arm trial lasting for 12 weeks. All patients received access to an app aimed to guide individuals to change or maintain a heart-healthy lifestyle. During the study period, patients received weekly, individualized monitoring through the app, based on their own goals. Feasibility outcomes assessed were recruitment rate, adherence to the app, resource requirements, and efficacy regarding capability to detect a change in quality of life, health status, and perceived goal achievement as well as evaluating ceiling and floor effect in these outcomes. Criteria for success were preset to be able to evaluate whether the app was feasible to use in a potential future RCT. Results: In total, 71% (17/24) of the patients who completed CR were eligible for a potential RCT as well as for this study. All 14 patients included in the study used the app to promote preventive activities throughout the study. Satisfaction with the technology was high, and the patients found the technology-based follow-up intervention both useful and motivational. Ceiling effect was present in more than 20% of the patients in several domains of the questionnaires evaluating quality of life (36-Item Short Form Health Survey and COOP/WONCA functional health assessments) and health status (EQ-5D). Overall self-rated health status (EuroQol Visual Analog Scale) and perceived goal achievement were found to be outcomes able to detect a change. Conclusions: Individual follow-up through an app after attendance in CR is feasible. All patients used the app for preventive activities and found the app both useful and motivating. Several points of guidance from the patients in the study have been adopted and incorporated into the final design of the RCT now in the field.

  • Adolescent using support tool. Source: Image created by the Authors; Copyright: The Authors; URL: http://formative.jmir.org/2019/2/e12406/; License: Creative Commons Attribution (CC-BY).

    Considerations of Privacy and Confidentiality in Developing a Clinical Support Tool for Adolescent Tobacco Prevention: Qualitative Study

    Abstract:

    Background: Electronic clinical support tools show promise for facilitating tobacco screening and counseling in adolescent well-care. However, the application of support tools in pediatric settings has not been thoroughly studied. Successfully implementing support tools in local settings requires an understanding of barriers and facilitators from the perspective of both patients and providers. Objective: This paper aimed to present the findings of a qualitative study conducted to inform the development and implementation of a support tool for adolescent tobacco screening and counseling in 3 pediatric clinics in North Florida. The primary objective of the study was to test and collect information needed to refine a tablet-based support tool with input from patients and providers in the study clinics. Methods: A tablet prototype was designed to collect information from adolescents on tobacco susceptibility and use before their well-care visit and to present tobacco prevention videos based on their responses. Information collected from adolescents by the support tool would be available to providers during the visit to facilitate and streamline tobacco use assessment and counseling components of well-care. Focus groups with providers and staff from 3 pediatric clinics (n=24) identified barriers and facilitators to implementation of the support tool. In-depth interviews with racially and ethnically diverse adolescent patients who screened as susceptible to tobacco use (n=16) focused on acceptability and usability of the tool. All focus groups and interviews were audio-recorded and transcribed for team-based coding using thematic analysis. Results: Privacy and confidentiality of information was a salient theme. Both groups expressed concerns that the tool’s audio and visual components would impede privacy and that parents may read their child’s responses or exert control over the process. Nearly all adolescents stated they would be comfortable with the option to complete the tool at home via a Web portal. Most adolescents stated they would feel comfortable discussing tobacco with their doctor. Adolescent interviews elicited 3 emergent themes that added context to perspectives on confidentiality and had practical implications for implementation: (1) purity: an expressed lack of concern for confidentiality among adolescents with no reported history of tobacco use; (2) steadfast honesty: a commitment to being honest with parents and providers about tobacco use, regardless of the situation; and (3) indifference: a perceived lack of relevance of confidentiality, based on the premise that others will “find out anyway” if adolescents are using tobacco. Conclusions: This study informed several modifications to the intervention to address confidentiality and introduce efficiency to well-care visits. The support tool was integrated into the electronic health record system used by the study clinics and modified to offer videos to all adolescents regardless of their tobacco use or susceptibility. Future studies will further test the acceptability of the intervention in practice.

  • Source: The Authors / Placeit; Copyright: JMIR Publications; URL: http://formative.jmir.org/2019/2/e11958/; License: Creative Commons Attribution (CC-BY).

    The Implementation of an mHealth Intervention (ReZone) for the Self-Management of Overwhelming Feelings Among Young People

    Abstract:

    Background: The association between mental health difficulties and academic attainment is well established. There is increasing research on mobile health (mHealth) interventions to provide support for the mental health and education of young people. However, nonadoption and inadequate implementation of mHealth interventions are prevalent barriers to such trials. Objective: The aim of this study was to bridge this gap and examine the implementation of an mHealth intervention, ReZone, for young people in schools. Methods: Preliminary data for 79 students collected as part of a larger trial were analyzed. We additionally conducted postimplementation consultations with teachers. Results: ReZone was used 1043 times by 36 students in the intervention arm during the study period. Postimplementation teacher consultations provided data on implementation strategies, barriers, and facilitators. Conclusions: Implementation strategies, barriers, and facilitators for digital interventions need to be considered to limit nonadoption and inadequate implementation in larger trials. Important considerations involve tailoring the characteristics of the intervention to the requirements of the intended user group, the technology itself, and the organization in which it is implemented. Trial Registration: International Standard Randomised Controlled Trial Number: 13425994; http://www.isrctn.com/ISRCTN13425994

  • A Wrapped condom demo. Source: Image created by the Authors; Copyright: The Authors; URL: https://formative.jmir.org/2019/2/e11242; License: Creative Commons Attribution (CC-BY).

    An Intervention to Increase Condom Use Among Users of Chlamydia Self-Sampling Websites (Wrapped): Intervention Mapping and Think-Aloud Study

    Abstract:

    Background: Young people aged 16-24 years are disproportionately affected by sexually transmitted infections (STIs). STIs can have serious health consequences for affected individuals and the estimated annual cost of treatment to the National Health Service is £620 million. Accordingly, the UK government has made reducing the rates of STIs among this group a priority. A missed opportunity to intervene to increase condom use is when young people obtain self-sampling kits for STIs via the internet. Objective: Our aim was to develop a theory-based tailored intervention to increase condom use for 16-24-years-olds accessing chlamydia self-sampling websites. Methods: The intervention, Wrapped, was developed using Intervention Mapping and was co-designed with young people. The following steps were performed: (1) identification of important determinants of condom use and evidence of their changeability using computer and digital interventions; (2) setting the intervention goal, performance objectives, and change objectives; (3) identification of Behavior Change Principles (BCPs) and practical strategies to target these determinants; and (4) development of intervention materials able to deliver the BCPs and practical strategies. Results: Users of existing chlamydia self-sampling websites are signposted to Wrapped after placing an order for a sampling kit. Salient barriers to condom use are identified by each user and relevant intervention components are allocated to target these. The components include the following: (1) a sample box of condoms, (2) an online condom distribution service, (3) a product for carrying condoms, (4) a condom demonstration video, (5) a series of videos on communication about condom use, and (6) erotic films of real couples discussing and demonstrating condom use. Conclusions: This intervention will be directed at young people who may be particularly receptive to messages and support for behavior change due to their testing status.

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://formative.jmir.org/2019/2/e11586/; License: Creative Commons Attribution (CC-BY).

    Feasibility Randomized Controlled Trial of ImpulsePal: Smartphone App–Based Weight Management Intervention to Reduce Impulsive Eating in Overweight Adults

    Abstract:

    Background: ImpulsePal is a theory-driven (dual-process), evidence-informed, and person-centered smartphone app intervention designed to help people manage impulsive processes that prompt unhealthy eating to facilitate dietary change and weight loss. Objective: The aims of this study were to (1) assess the feasibility of trial procedures for evaluation of the ImpulsePal intervention, (2) estimate standard deviations of outcomes, and (3) assess usability of, and satisfaction with, ImpulsePal. Methods: We conducted an individually randomized parallel two-arm nonblinded feasibility trial. The eligibility criteria included being aged ≥16 years, having a body mass index of ≥25 kg/m2, and having access to an Android-based device. Weight was measured (as the proposed primary outcome for a full-scale trial) at baseline, 1 month, and 3 months of follow-up. Participants were randomized in a 2:1 allocation ratio to the ImpulsePal intervention or a waiting list control group. A nested action-research study allowed for data-driven refinement of the intervention across 2 cycles of feedback. Results: We screened 179 participants for eligibility, and 58 were randomized to the intervention group and 30 to the control group. Data were available for 74 (84%, 74/88) participants at 1 month and 67 (76%, 67/88) participants at 3 months. The intervention group (n=43) lost 1.03 kg (95% CI 0.33 to 1.74) more than controls (n=26) at 1 month and 1.01 kg (95% CI −0.45 to 2.47) more than controls (n=43 and n=24, respectively) at 3 months. Feedback suggested changes to intervention design were required to (1) improve receipt and understanding of instructions and (2) facilitate further engagement with the app and its strategies. Conclusions: The evaluation methods and delivery of the ImpulsePal app intervention are feasible, and the trial procedures, measures, and intervention are acceptable and satisfactory to the participants. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 14886370; http://www.isrctn.com/ISRCTN14886370 (Archived by WebCite at http://www.webcitation.org/76WcEpZ51)

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  • Using Wearable Devices to Remotely Monitor Sleep Patterns among Patients with Ischemic Heart Disease

    Date Submitted: Apr 28, 2019

    Open Peer Review Period: May 1, 2019 - Jun 26, 2019

    Background: There is growing interest in using wearable devices to remotely monitor patient behaviors. However, there has been little evaluation of the feasibility of using these technologies to monit...

    Background: There is growing interest in using wearable devices to remotely monitor patient behaviors. However, there has been little evaluation of the feasibility of using these technologies to monitor sleep patterns, particularly among more high-risk patients. Objective: To evaluate how patients with ischemic heart disease used wearable devices to monitor their sleep and identify differences in characteristics of patients with higher versus lower utilization. Methods: We evaluated wearable device data from a previously conducted clinical trial testing the use of wearable devices with personalized goal-setting and financial incentives. Patients with ischemic heart disease established a sleep baseline and then were followed for 6 months. The proportion of days that sleep data was collected was compared over the 6 months and by study arm. Characteristics of patients were compared to groups with high, low, or no sleep data. Results: The sample comprised 99 patients with ischemic heart disease, among which 79% used the wearable device to track their sleep. During the 6-month trial, sleep data was collected on 60% of patient-days. These rates declined over time from 77% in months 1-2 to 58% in months 3-4 to 46% in months 5-6. Sleep data was collected at higher rates among the intervention group compared to control (67% vs. 55%, p<0.001). In the main intervention period (months 3-4), patients with higher rates of sleep data were on average older (p<0.05), had a history of smoking (p<0.01), and had higher rates of commercial health insurance (p<0.05). Conclusions: Among patients with ischemic heart disease in a physical activity trial, a high proportion used wearable devices to track their sleep, however rates declined over time. The study of sleep patterns with wearable devices is feasible, and future research should consider larger evaluations coupled with behavioral interventions Clinical Trial: https://www.clinicaltrials.gov. Unique identifier: NCT02531022

  • Children and young people’s experiences of how to achieve participation within pediatric rehabilitation services: A formative qualitative study for the development of a digital decision support tool for children with disabilities

    Date Submitted: Apr 25, 2019

    Open Peer Review Period: Apr 30, 2019 - Jun 25, 2019

    Background: Building a health-care system of justice requires a child-centered care where children and young people, regardless of ability, are allowed to participate in their contact with their healt...

    Background: Building a health-care system of justice requires a child-centered care where children and young people, regardless of ability, are allowed to participate in their contact with their healthcare professionals. Implementation of interventions that support children’s participation in healthcare is still rare, and especially so when it comes to children with disabilities. Yet the consequences of insufficient participation are particularly severe for children with disabilities, as their needs for extensive care place greater demands on efficient interaction with professionals. Objective: As part of an overall project focusing on developing and implementing a digital decision support tool to increase participation within pediatric rehabilitation, the aim of this formative study was to explore the experiences of children and young people with disabilities regarding how to achieve participation within the pediatric rehabilitation services. Methods: The formative study has an explorative design, based on a latent qualitative content analysis with an inductive approach. Interviews were conducted with 20 children (6-17 years) and eight young people (19-30 years) with disabilities about their experiences of participation within pediatric rehabilitation services. Results: Three categories emerged reflecting the participants’ possibilities of participation within the pediatric rehabilitation services: to feel involved; to feel independent, and to feel partnership. To feel involved meant being listened to and to being connected; to feel independent meant being admitted and being enabled, and to feel partnership meant being supported and being able to entrust others with the decision-making. Through the overall theme “moving toward empowerment for children in pediatric rehabilitation”, a true feeling of participation can be experienced. Conclusions: The views of children and young people with disabilities are that children within the pediatric rehabilitation services must be given prerequisites for empowerment through being allowed to feel involved, independent, and in partnership, in order to experience true participation within their pediatric rehabilitation services. This finding will become imperative when designing a forthcoming digital decision support tool based on the children’s needs and perspectives.

  • Online Health Information Seeking Among Kuwait University Students

    Date Submitted: Apr 9, 2019

    Open Peer Review Period: Apr 11, 2019 - Jun 6, 2019

    Background: Background: Due to the revolution in technology, the internet has become an important aspect in the lives of people. Modern technology is enabling people from different educational levels...

    Background: Background: Due to the revolution in technology, the internet has become an important aspect in the lives of people. Modern technology is enabling people from different educational levels to use the internet for several purposes, one of which is health information seeking. Recently, online health information has become more popular among patients all over the world, as well as the general public. Objective: Objectives: This study aims to investigate the use of online health resources among undergraduate students in Kuwait University. Methods: Methods: The study employed a cross-sectional design with students selected from eight faculties of Kuwait University, four of which are Literature and four are Science faculties. Data was collected using structured questionnaires, and analysis was done using chi-square test and binary logistic regression to determine the factors associated with seeking health information online. Results: Results: The sample size obtained was 1132 with a response rate of 90.3%. Overall, the prevalence of students seeking online health information was 86.2%. The most significant factors associated with seeking health information online were age, gender, faculty, year of study, primary source of internet, and level of experience with internet use. Ninety percent of students who are more than 21 years old, used online health information compared to 83% of those who are 18 years old. Also, Female students showed a higher prevalence (88.8%) of online health information seeking than males (77.8%). All the differences found in the study were significant (P value < 0.05). Conclusions: Conclusion: The study concluded that a large number of people use the internet for seeking health information online. Socio-demographic factors have a significant association to online health information seeking. Therefore, education has to be provided by the doctors to the public about the websites that the people can trust.

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