%0 Journal Article %@ 2291-9694 %I JMIR Publications %V 13 %N %P e67589 %T An Ontology for Digital Medicine Outcomes: Development of the Digital Medicine Outcomes Value Set (DOVeS) %A Rosner,Benjamin %A Horridge,Matthew %A Austria,Guillen %A Lee,Tiffany %A Auerbach,Andrew %+ , Division of Clinical Informatics and Digital Transformation, University of California San Francisco, 10 Koret Way, Room K-301, UCSF DOM CLIIR Box 0737, San Francisco, CA, 94143, United States, 1 415 502 1371, benjamin.rosner@ucsf.edu %K digital health %K digital medicine %K digital therapeutics %K ontology %K medical informatics %K value set %K ontology %K development %K digital health tool %K DHT %K health systems %K digital medicine outcomes value set %K prototype %K users %D 2025 %7 6.2.2025 %9 Original Paper %J JMIR Med Inform %G English %X Background: Over the last 10-15 years, US health care and the practice of medicine itself have been transformed by a proliferation of digital medicine and digital therapeutic products (collectively, digital health tools [DHTs]). While a number of DHT classifications have been proposed to help organize these tools for discovery, retrieval, and comparison by health care organizations seeking to potentially implement them, none have specifically addressed that organizations considering their implementation approach the DHT discovery process with one or more specific outcomes in mind. An outcomes-based DHT ontology could therefore be valuable not only for health systems seeking to evaluate tools that influence certain outcomes, but also for regulators and vendors seeking to ascertain potential substantial equivalence to predicate devices. Objective: This study aimed to develop, with inputs from industry, health care providers, payers, regulatory bodies, and patients through the Accelerated Digital Clinical Ecosystem (ADviCE) consortium, an ontology specific to DHT outcomes, the Digital medicine Outcomes Value Set (DOVeS), and to make this ontology publicly available and free to use. Methods: From a starting point of a 4-generation–deep hierarchical taxonomy developed by ADviCE, we developed DOVeS using the Web Ontology Language through the open-source ontology editor Protégé, and data from 185 vendors who had submitted structured product information to ADviCE. We used a custom, decentralized, collaborative ontology engineering methodology, and were guided by Open Biological and Biomedical Ontologies (OBO) Foundry principles. We incorporated the Mondo Disease Ontology (MONDO) and the Ontology of Adverse Events. After development, DOVeS was field-tested between December 2022 and May 2023 with 40 additional independent vendors previously unfamiliar with ADviCE or DOVeS. As a proof of concept, we subsequently developed a prototype DHT Application Finder leveraging DOVeS to enable a user to query for DHT products based on specific outcomes of interest. Results: In its current state, DOVeS contains 42,320 and 9481 native axioms and distinct classes, respectively. These numbers are enhanced when taking into account the axioms and classes contributed by MONDO and the Ontology of Adverse Events. Conclusions: DOVeS is publicly available on BioPortal and GitHub, and has a Creative Commons license CC-BY-SA that is intended to encourage stakeholders to modify, adapt, build upon, and distribute it. While no ontology is complete, DOVeS will benefit from a strong and engaged user base to help it grow and evolve in a way that best serves DHT stakeholders and the patients they serve. %M 39914801 %R 10.2196/67589 %U https://medinform.jmir.org/2025/1/e67589 %U https://doi.org/10.2196/67589 %U http://www.ncbi.nlm.nih.gov/pubmed/39914801 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e50339 %T Blockchain-Based Dynamic Consent and its Applications for Patient-Centric Research and Health Information Sharing: Protocol for an Integrative Review %A Charles,Wendy M %A van der Waal,Mark B %A Flach,Joost %A Bisschop,Arno %A van der Waal,Raymond X %A Es-Sbai,Hadil %A McLeod,Christopher J %+ Health Administration Program, Business School, University of Colorado, Denver, 1475 Lawrence Street, Denver, CO, 80202, United States, 1 303 250 1148, wendy.charles@cuanschutz.edu %K best practices %K blockchain %K clinical trial %K data reuse %K data sharing %K dynamic consent %K health care data %K integrative research review %K scientific rigor %K technology implementation %D 2024 %7 5.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Blockchain has been proposed as a critical technology to facilitate more patient-centric research and health information sharing. For instance, it can be applied to coordinate and document dynamic informed consent, a procedure that allows individuals to continuously review and renew their consent to the collection, use, or sharing of their private health information. Such has been suggested to facilitate ethical, compliant longitudinal research, and patient engagement. However, blockchain-based dynamic consent is a relatively new concept, and it is not yet clear how well the suggested implementations will work in practice. Efforts to critically evaluate implementations in health research contexts are limited. Objective: The objective of this protocol is to guide the identification and critical appraisal of implementations of blockchain-based dynamic consent in health research contexts, thereby facilitating the development of best practices for future research, innovation, and implementation. Methods: The protocol describes methods for an integrative review to allow evaluation of a broad range of quantitative and qualitative research designs. The PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) framework guided the review’s structure and nature of reporting findings. We developed search strategies and syntax with the help of an academic librarian. Multiple databases were selected to identify pertinent academic literature (CINAHL, Embase, Ovid MEDLINE, PubMed, Scopus, and Web of Science) and gray literature (Electronic Theses Online Service, ProQuest Dissertations and Theses, Open Access Theses and Dissertations, and Google Scholar) for a comprehensive picture of the field’s progress. Eligibility criteria were defined based on PROSPERO (International Prospective Register of Systematic Reviews) requirements and a criteria framework for technology readiness. A total of 2 reviewers will independently review and extract data, while a third reviewer will adjudicate discrepancies. Quality appraisal of articles and discussed implementations will proceed based on the validated Mixed Method Appraisal Tool, and themes will be identified through thematic data synthesis. Results: Literature searches were conducted, and after duplicates were removed, 492 articles were eligible for screening. Title and abstract screening allowed the removal of 312 articles, leaving 180 eligible articles for full-text review against inclusion criteria and confirming a sufficient body of literature for project feasibility. Results will synthesize the quality of evidence on blockchain-based dynamic consent for patient-centric research and health information sharing, covering effectiveness, efficiency, satisfaction, regulatory compliance, and methods of managing identity. Conclusions: The review will provide a comprehensive picture of the progress of emerging blockchain-based dynamic consent technologies and the rigor with which implementations are approached. Resulting insights are expected to inform best practices for future research, innovation, and implementation to benefit patient-centric research and health information sharing. Trial Registration: PROSPERO CRD42023396983; http://tinyurl.com/cn8a5x7t International Registered Report Identifier (IRRID): DERR1-10.2196/50339 %M 38315514 %R 10.2196/50339 %U https://www.researchprotocols.org/2024/1/e50339 %U https://doi.org/10.2196/50339 %U http://www.ncbi.nlm.nih.gov/pubmed/38315514 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46115 %T Understanding Whether and How a Digital Health Intervention Improves Transition Care for Emerging Adults Living With Type 1 Diabetes: Protocol for a Mixed Methods Realist Evaluation %A Wang,Ruoxi %A Rouleau,Geneviève %A Booth,Gillian Lynn %A Brazeau,Anne-Sophie %A El-Dassouki,Noor %A Taylor,Madison %A Cafazzo,Joseph A %A Greenberg,Marley %A Nakhla,Meranda %A Shulman,Rayzel %A Desveaux,Laura %+ Institute for Better Health, Trillium Health Partners, 100 Queensway W, Mississauga, ON, L5B 1B8, Canada, 1 437 772 6836, laura.desveaux@thp.ca %K digital health %K emerging adults %K realist evaluation %K self-management %K transition to adult care %K type 1 diabetes %D 2023 %7 13.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Emerging adults living with type 1 diabetes (T1D) face a series of challenges with self-management and decreased health system engagement, leading to an increased risk of acute complications and hospital admissions. Effective and scalable strategies are needed to support this population to transfer seamlessly from pediatric to adult care with sufficient self-management capability. While digital health interventions for T1D self-management are a promising strategy, it remains unclear which elements work, how, and for which groups of individuals. Objective: This study aims to evaluate the design and implementation of a multicomponent SMS text message–based digital health intervention to support emerging adults living with T1D in real-world settings. The objectives are to identify the intervention components and associated mechanisms that support user engagement and T1D health care transition experiences and determine the individual characteristics that influence the implementation process. Methods: We used a realist evaluation embedded alongside a randomized controlled trial, which uses a sequential mixed methods design to analyze data from multiple sources, including intervention usage data, patient-reported outcomes, and realist interviews. In step 1, we conducted a document analysis to develop a program theory that outlines the hypothesized relationships among “individual-level contextual factors, intervention components and features, mechanisms, and outcomes,” with special attention paid to user engagement. Among them, intervention components and features depict 10 core characteristics such as transition support information, problem-solving information, and real-time interactivity. The proximal outcomes of interest include user engagement, self-efficacy, and negative emotions, whereas the distal outcomes of interest include transition readiness, self-blood glucose monitoring behaviors, and blood glucose. In step 2, we plan to conduct semistructured realist interviews with the randomized controlled trial’s intervention-arm participants to test the hypothesized “context-intervention-mechanism-outcome” configurations. In step 3, we plan to triangulate all sources of data using a coincidence analysis to identify the necessary combinations of factors that determine whether and how the desired outcomes are achieved and use these insights to consolidate the program theory. Results: For step 1 analysis, we have developed the initial program theory and the corresponding data collection plan. For step 2 analysis, participant enrollment for the randomized controlled trial started in January 2023. Participant enrollment for this realist evaluation was anticipated to start in July 2023 and continue until we reached thematic saturation or achieved informational power. Conclusions: Beyond contributing to knowledge on the multiple pathways that lead to successful engagement with a digital health intervention as well as target outcomes in T1D care transitions, embedding the realist evaluation alongside the trial may inform real-time intervention refinement to improve user engagement and transition experiences. The knowledge gained from this study may inform the design, implementation, and evaluation of future digital health interventions that aim to improve transition experiences. International Registered Report Identifier (IRRID): PRR1-10.2196/46115 %M 37703070 %R 10.2196/46115 %U https://www.researchprotocols.org/2023/1/e46115 %U https://doi.org/10.2196/46115 %U http://www.ncbi.nlm.nih.gov/pubmed/37703070 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 5 %N 3 %P e36515 %T Mitigating Feelings of Loneliness and Depression by Means of Web-Based or Print-Based Physical Activity Interventions: Pooled Analysis of 2 Community-Based Intervention Trials %A Lippke,Sonia %A Ratz,Tiara %A Keller,Franziska Maria %A Juljugin,Dennis %A Peters,Manuela %A Pischke,Claudia %A Voelcker-Rehage,Claudia %+ Psychology & Methods, Jacobs University Bremen, Campus Ring 1, Bremen, 28759, Germany, 49 421200 ext 4730, s.lippke@jacobs-university.de %K physical activity %K older adults %K intervention %K loneliness %K depression %K eHealth %K mobile health %K mHealth %D 2022 %7 9.8.2022 %9 Original Paper %J JMIR Aging %G English %X Background: Physical activity (PA) is associated with benefits, such as fewer depressive symptoms and loneliness. Web- and print-based PA interventions can help older individuals accordingly. Objective: We aimed to test the following research questions: Do PA interventions delivered in a web- or print-based mode improve self-reported PA stage of change, social-cognitive determinants of PA, loneliness, and symptoms of depression? Is subjective age a mediator and stage of change a moderator of this effect? Methods: Overall, 831 adults aged ≥60 years were recruited and either allocated to a print-based or web-based intervention group or assigned to a wait-list control group (WLCG) in 2 community-based PA intervention trials over 10 weeks. Missing value imputation using an expectation-maximization algorithm was applied. Frequency analyses, multivariate analyses of variance, and moderated mediation analyses were conducted. Results: The web-based intervention outperformed (47/59, 80% of initially inactive individuals being adopters, and 396/411, 96.4% of initially active individuals being maintainers of the recommended PA behavior) the print-based intervention (20/25, 80% of adopters, and 63/69, 91% of maintainers) and the WLCG (5/7, 71% of adopters; 141/150, 94% of maintainers). The pattern regarding adopters was statistically significant (web vs print Z=–1.94; P=.02; WLCG vs web Z=3.8367; P=.01). The pattern was replicated with stages (χ24=79.1; P<.001; contingency coefficient 0.314; P<.001); in the WLCG, 40.1% (63/157) of the study participants moved to or remained in action stage. This number was higher in the groups receiving web-based (357/470, 76%) or print-based interventions (64/94, 68.1%). A significant difference was observed favoring the 2 intervention groups over and above the WLCG (F19, 701=4.778; P<.001; η2=0.098) and a significant interaction of time and group (F19, 701=2.778; P<.001; η2=0.070) for predictors of behavior. The effects of the interventions on subjective age, loneliness, and depression revealed that both between-group effects (F3, 717=8.668; P<.001; η2=0.018) and the interaction between group and time were significant (F3, 717=6.101; P<.001; η2=0.025). In a moderated mediation model, both interventions had a significant direct effect on depression in comparison with the WLCG (web-based: c′ path −0.86, 95% CI −1.58 to −0.13, SE 0.38; print-based: c′ path −1.96, 95% CI −2.99 to −0.92, SE 0.53). Furthermore, subjective age was positively related to depression (b path 0.14, 95% CI 0.05-0.23; SE 0.05). An indirect effect of the intervention on depression via subjective age was only present for participants who were in actor stage and received the web-based intervention (ab path −0.14, 95% CI −0.34 to −0.01; SE 0.09). Conclusions: Web-based interventions appear to be as effective as print-based interventions. Both modes might help older individuals remain or become active and experience fewer depression symptoms, especially if they feel younger. Trial Registration: German Registry of Clinical Trials DRKS00010052 (PROMOTE 1); https://tinyurl.com/nnzarpsu and DRKS00016073 (PROMOTE 2); https://tinyurl.com/4fhcvkwy International Registered Report Identifier (IRRID): RR2-10.2196/15168 %M 35943790 %R 10.2196/36515 %U https://aging.jmir.org/2022/3/e36515 %U https://doi.org/10.2196/36515 %U http://www.ncbi.nlm.nih.gov/pubmed/35943790 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e30673 %T Describing Transitions in Adherence to Physical Activity Self-monitoring and Goal Attainment in an Online Behavioral Weight Loss Program: Secondary Analysis of a Randomized Controlled Trial %A Stansbury,Melissa L %A Harvey,Jean %A Krukowski,Rebecca A %A Pellegrini,Christine A %A Wang,Xuewen %A West,Delia Smith %+ Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Discovery 1 Bldg, Suite 403, 915 Greene Street, Columbia, SC, 29208, United States, 1 803 777 0510, stansbm@email.sc.edu %K physical activity %K adherence %K self-monitoring %K goal attainment %K lifestyle intervention %D 2022 %7 28.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Standard behavioral weight loss interventions often set uniform physical activity (PA) goals and promote PA self-monitoring; however, adherence remains a challenge, and recommendations may not accommodate all individuals. Identifying patterns of PA goal attainment and self-monitoring behavior will offer a deeper understanding of how individuals adhere to different types of commonly prescribed PA recommendations (ie, minutes of moderate-to-vigorous physical activity [MVPA] and daily steps) and guide future recommendations for improved intervention effectiveness. Objective: This study examined weekly patterns of adherence to step-based and minute-based PA goals and self-monitoring behavior during a 6-month online behavioral weight loss intervention. Methods: Participants were prescribed weekly PA goals for steps (7000-10,000 steps/day) and minutes of MVPA (50-200 minutes/week) as part of a lifestyle program. Goals gradually increased during the initial 2 months, followed by 4 months of fixed goals. PA was self-reported daily on the study website. For each week, participants were categorized as adherent if they self-monitored their PA and met the program PA goal, suboptimally adherent if they self-monitored but did not meet the program goal, or nonadherent if they did not self-monitor. The probability of transitioning into a less adherent status was examined using multinomial logistic regression. Results: Participants (N=212) were predominantly middle-aged females with obesity, and 67 (31.6%) self-identified as a racial/ethnic minority. Initially, 73 (34.4%) participants were categorized as adherent to step-based goals, with 110 [51.9%] suboptimally adherent and 29 [13.7%] nonadherent, and there was a high probability of either remaining suboptimally adherent from week to week or transitioning to a nonadherent status. However, 149 (70.3%) participants started out adherent to minute-based goals (34 [16%] suboptimally adherent and 29 [13.7%] nonadherent), with suboptimally adherent seen as the most variable status. During the graded goal phase, participants were more likely to transition to a less adherent status for minute-based goals (odds ratio [OR] 1.39, 95% CI 1.31-1.48) compared to step-based goals (OR 1.24, 95% CI 1.17-1.30); however, no differences were seen during the fixed goal phase (minute-based goals: OR 1.06, 95% CI 1.05-1.08; step-based goals: OR 1.07, 95% CI 1.05-1.08). Conclusions: States of vulnerability to poor PA adherence can emerge rapidly and early in obesity treatment. There is a window of opportunity within the initial 2 months to bring more people toward adherent behavior, especially those who fail to meet the prescribed goals but engage in self-monitoring. Although this study describes the probability of adhering to step- and minute-based targets, it will be prudent to determine how individual characteristics and contextual states relate to these behavioral patterns, which can inform how best to adapt interventions. Trial Registration: ClinicalTrials.gov NCT02688621; https://clinicaltrials.gov/ct2/show/NCT02688621 %M 35089159 %R 10.2196/30673 %U https://www.jmir.org/2022/1/e30673 %U https://doi.org/10.2196/30673 %U http://www.ncbi.nlm.nih.gov/pubmed/35089159 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 1 %P e24239 %T A Digital Intervention for Respiratory Tract Infections (Internet Dr): Process Evaluation to Understand How to Support Self-care for Minor Ailments %A Miller,Sascha %A Yardley,Lucy %A Smith,Peter %A Weal,Mark %A Anderson,Alexander %A Stuart,Beth %A Little,Paul %A Morrison,Leanne %+ Center for Clinical and Community Applications of Health Psychology, Department of Psychology, University of Southampton, Building 44, Highfield Campus, Southampton, SO17 1BJ, United Kingdom, 44 02380595000, S.Miller@soton.ac.uk %K illness behavior %K self-care %K internet %K evaluation studies %K respiratory tract infection %K mobile phone %D 2022 %7 19.1.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Approximately 57 million physician appointments annually in the United Kingdom are for minor ailments. These illnesses could be self-cared for, which would potentially lower patients’ anxiety, increase their confidence, and be more convenient. In a randomized controlled trial of the Internet Dr digital intervention, patients with access to the intervention had fewer consultations for respiratory tract infections (RTIs). Having established intervention efficacy, further examination of trial data is required to understand how the intervention works. Objective: This paper reports a process evaluation of Internet Dr usage by the intervention group. The evaluation aims to demonstrate how meaningful usage metrics (ie, interactions that are specific and relevant to the intervention) can be derived from the theoretical principles underlying the intervention, then applied to examine whether these interactions are effective in supporting self-care for RTIs, for whom, and at what time. Methods: The Internet Dr trial recorded patients’ characteristics and usage data over 24 weeks. At follow-up, users reported whether their levels of enablement to cope with their illness changed over the trial period. The Medical Research Council process evaluation guidance and checklists from the framework for Analyzing and Measuring Usage and Engagement Data were applied to structure research questions examining associations between usage and enablement. Results: Viewing pages containing advice on caring for RTIs were identified as a meaningful metric for measuring intervention usage. Almost half of the users (616/1491, 42.31%) viewed at least one advice page, with most people (478/616, 77.6%) accessing them when they initially enrolled in the study. Users who viewed an advice page reported increased enablement to cope with their illness as a result of having participated in the study compared with users who did not (mean 2.12, SD 2.92 vs mean 1.65, SD 3.10; mean difference 0.469, 95% CI 0.082-0.856). The target population was users who had visited their general practitioners for an RTI in the year before the trial, and analyses revealed that this group was more likely to access advice pages (odds ratio 1.35, 95% CI 1.159-1.571; P<.001). Conclusions: The process evaluation identifies viewing advice pages as associated with increased enablement to self-care, even when accessed in the absence of a RTI, meaning that dissemination activities need not be restricted to targeting users who are ill. The intervention was effective at reaching the target population of users who had previously consulted their general practitioners. However, attrition before reaching advice pages was high, highlighting the necessity of prioritizing access during the design phase. These findings provide guidance on how the intervention may be improved and disseminated and have wider implications for minor ailment interventions. %M 35044317 %R 10.2196/24239 %U https://formative.jmir.org/2022/1/e24239 %U https://doi.org/10.2196/24239 %U http://www.ncbi.nlm.nih.gov/pubmed/35044317 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 6 %P e25470 %T Fidelity of Delivery and Contextual Factors Influencing Children’s Level of Engagement: Process Evaluation of the Online Remote Behavioral Intervention for Tics Trial %A Khan,Kareem %A Hollis,Chris %A Hall,Charlotte L %A Murray,Elizabeth %A Davies,E Bethan %A Andrén,Per %A Mataix-Cols,David %A Murphy,Tara %A Glazebrook,Cris %+ Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham, Institute of Mental Health, Jubilee Campus, University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU, United Kingdom, 44 0115 823 1294, kareem.khan@nottingham.ac.uk %K process evaluation %K implementation fidelity %K Tourette syndrome %K chronic tic disorders %K online behavioral intervention %K mixed methods %K children and young people %D 2021 %7 21.6.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The Online Remote Behavioral Intervention for Tics (ORBIT) study was a multicenter randomized controlled trial of a complex intervention that consisted of a web-based behavioral intervention for children and young people with tic disorders. In the first part of a two-stage process evaluation, we conducted a mixed methods study exploring the reach, dose, and fidelity of the intervention and contextual factors influencing engagement. Objective: This study aims to explore the fidelity of delivery and contextual factors underpinning the ORBIT trial. Methods: Baseline study data and intervention usage metrics from participants in the intervention arm were used as quantitative implementation data (N=112). The experiences of being in the intervention were explored through semistructured interviews with children (n=20) and parent participants (n=20), therapists (n=4), and referring clinicians (n=6). A principal component analysis was used to create a comprehensive, composite measure of children and young people’s engagement with the intervention. Engagement factor scores reflected relative uptake as assessed by a range of usage indices, including chapters accessed, number of pages visited, and number of log-ins. The engagement factor score was used as the dependent variable in a multiple linear regression analysis with various contextual variables as independent variables to assess if there were any significant predictors of engagement. Results: The intervention was implemented with high fidelity, and participants deemed the intervention acceptable and satisfactory. The engagement was high, with child participants completing an average of 7.5 of 10 (SD 2.7) chapters, and 88.4% (99/112) of participants completed the minimum of the first four chapters—the predefined threshold effective dose. Compared with the total population of children with tic disorders, participants in the sample tended to have more educated parents and lived in more economically advantaged areas; however, socioeconomic factors were not related to engagement factor scores. Factors associated with higher engagement factor scores included participants enrolled at the London site versus the Nottingham site (P=.01), self-referred versus clinic referred (P=.04), higher parental engagement as evidenced by the number of parental chapters completed (n=111; ρ=0.73; P<.001), and more therapist time for parents (n=111; ρ=0.46; P<.001). A multiple linear regression indicated that parents’ chapter completion (β=.69; t110=10.18; P<.001) and therapist time for parents (β=.19; t110=2.95; P=.004) were the only significant independent predictors of child engagement factor scores. Conclusions: Overall, the intervention had high fidelity of delivery and was evaluated positively by participants, although reach may have been constrained by the nature of the randomized controlled trial. Parental engagement and therapist time for parents were strong predictors of intervention implementation, which has important implications for designing and implementing digital therapeutic interventions in child and adolescent mental health services. International Registered Report Identifier (IRRID): RR2-10.1186/s13063-019-3974-3 %M 34152270 %R 10.2196/25470 %U https://www.jmir.org/2021/6/e25470 %U https://doi.org/10.2196/25470 %U http://www.ncbi.nlm.nih.gov/pubmed/34152270 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 4 %P e28216 %T Patients’ Experiences of a Nurse-Led, Home-Based Heart Failure Self-management Program: Findings From a Qualitative Process Evaluation %A Jiang,Ying %A Koh,Karen Wei Ling %A Ramachandran,Hadassah Joann %A Tay,Yee Kian %A Wu,Vivien Xi %A Shorey,Shefaly %A Wang,Wenru %+ Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 2, Blk MD11, 10 Medical Drive, Singapore, 117597, Singapore, 65 66011761, nurww@nus.edu.sg %K self-care %K psychosocial educational %K nurse-led %K mHealth %K self-management %K heart failure %K process evaluation %K nursing %K mobile phone %D 2021 %7 27.4.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Heart failure (HF) is a major public health problem that places a significant disease burden on society. Self-care is important in the management of HF because it averts disease progression and reduces the number of hospitalizations. Effective nursing interventions promote HF self-care. Objective: This study aims to explore participants’ perspectives on a nurse-led, home-based heart failure self-management program (HOM-HEMP) in a randomized controlled trial conducted in Singapore to gain insight into the effectiveness of the study intervention. Methods: A descriptive, qualitative approach was used. English- or Chinese-speaking participants from the intervention arms were recruited through a purposive sampling method from January 2019 to July 2019. Individual, face-to-face, semistructured interviews were conducted with 11 participants. All interviews were audio recorded and transcribed verbatim, with the participant identifiers omitted to ensure confidentiality. The thematic analysis approach was used to identify, analyze, and report patterns (themes) within the data. Results: A total of six themes emerged from the process evaluation interviews and were categorized according to the Donabedian structure-process-outcome framework as intervention structure, intervention process, and intervention outcome. These six themes were manageability of the intervention, areas for improvement, benefits of visiting, personal accountability in self-care, empowered with knowledge and skills in self-care after the intervention, and increased self-efficacy in cardiac care. Conclusions: The findings of the process evaluation provided additional information on participants’ perceptions and experiences with the HOM-HEMP intervention. Although a home visit may be perceived as resource intensive, it remains to be the preferred way of engagement for most patients. Nurses play an important role in promoting HF self-care. The process of interaction with the patient can be an important process for empowering self-care behavior changes. %M 33904823 %R 10.2196/28216 %U https://www.jmir.org/2021/4/e28216 %U https://doi.org/10.2196/28216 %U http://www.ncbi.nlm.nih.gov/pubmed/33904823 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 8 %N 1 %P e20860 %T A Blended Electronic Illness Management and Recovery Program for People With Severe Mental Illness: Qualitative Process Evaluation Alongside a Randomized Controlled Trial %A Beentjes,Titus A A %A van Gaal,Betsie G I %A Vermeulen,Hester %A Nijhuis-van der Sanden,Maria W G %A Goossens,Peter J J %+ Dimence Group Mental Health Care Centre, Pikeursbaan 3, Deventer, 7411 GT, Netherlands, 31 651284459, titus.beentjes@radboudumc.nl %K mental health recovery %K self-management %K telemedicine %K mental health services %K qualitative research %D 2021 %7 20.1.2021 %9 Original Paper %J JMIR Ment Health %G English %X Background: We conducted a trial to test the electronic Illness Management and Recovery (e-IMR) intervention to provide conclusions on the potential efficacy of eHealth for people with severe mental illness (SMI). In the e-IMR intervention, we used the standard IMR program content and methodology and combined face-to-face sessions with internet-based strategies on the constructed e-IMR internet platform. During the trial, the e-IMR platform was sparsely used. Objective: This study aimed to evaluate the added value of the e-IMR intervention and the barriers and facilitators that can explain the low use of the e-IMR platform. Methods: This process evaluation was designed alongside a multicenter, cluster randomized controlled trial. In this study, we included all available participants and trainers from the intervention arm of the trial. Baseline characteristics were used to compare users with nonusers. Qualitative data were gathered at the end of the semistructured interviews. Using theoretical thematic analyses, the data were analyzed deductively using a pre-existing coding frame. Results: Out of 41 eligible participants and 14 trainers, 27 participants and 11 trainers were interviewed. Of the 27 participants, 10 were identified as users. eHealth components that had added value were the persuasive nature of the goal-tracking sheets, monitoring, and the peer testimonials, which had the potential to enhance group discussions and disclosure by participants. The low use of the e-IMR platform was influenced by the inflexibility of the platform, the lack of information technology (IT) resources, the group context, participants’ low computer skills and disabilities, and the hesitant eHealth attitude of the trainers. Conclusions: The extent of eHealth readiness and correlations with vulnerabilities in persons with SMI need further investigation. This study shows that flexible options were needed for the use of e-IMR components and that options should be provided only in response to a participant’s need. Use of the e-IMR intervention in the future is preconditioned by checking the available IT resources (such as tablets for participants) providing computer or internet guidance to participants outside the group sessions, evaluating the eHealth attitude and skills of trainers, and tailoring eHealth training to increase the skills of future e-IMR trainers. Trial Registration: Netherlands Trial Register NTR4772; https://www.trialregister.nl/trial/4621 International Registered Report Identifier (IRRID): RR2-10.1186/s12913-016-1267-z %M 33470945 %R 10.2196/20860 %U http://mental.jmir.org/2021/1/e20860/ %U https://doi.org/10.2196/20860 %U http://www.ncbi.nlm.nih.gov/pubmed/33470945 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 12 %P e19150 %T A Mobile- and Web-Based Health Intervention Program for Diabetes and Prediabetes Self-Management (BetaMe/Melon): Process Evaluation Following a Randomized Controlled Trial %A Signal,Virginia %A McLeod,Melissa %A Stanley,James %A Stairmand,Jeannine %A Sukumaran,Nitin %A Thompson,Donna-Marie %A Henderson,Kelly %A Davies,Cheryl %A Krebs,Jeremy %A Dowell,Anthony %A Grainger,Rebecca %A Sarfati,Diana %+ Department of Public Health, University of Otago Wellington, 23a Mein Street, Newtown, Wellington, , New Zealand, 64 212631385, virginia.signal@otago.ac.nz %K diabetes mellitus %K prediabetes %K self-management %K eHealth %K mobile apps %K evaluation %K diabetes %K digital health %K app %K utilization %K user perception %K user %D 2020 %7 1.12.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Technology-assisted self-management programs are increasingly recommended to patients with long-term conditions such as diabetes. However, there are a number of personal and external factors that affect patients’ abilities to engage with and effectively utilize such programs. A randomized controlled trial of a multi-modal online program for diabetes self-management (BetaMe/Melon) was conducted in a primary care setting, and a process evaluation was completed at the end of the study period. Objective: This process evaluation aimed to examine the utilization patterns of BetaMe/Melon, identify which components participants found most (and least) useful, and identify areas of future improvement. Methods: Process evaluation data were collected for intervention arm participants from 3 sources: (1) the mobile/web platform (to identify key usage patterns over the 16-week core program), (2) an online questionnaire completed during the final study assessment, and (3) interviews conducted with a subset of participants following the study period. Participants were classified as “actively engaged” if any usage data was recorded for the participant (in any week), and patterns were reported by age, gender, ethnicity, and diabetes/prediabetes status. The online questionnaire asked participants about the usefulness of the program and whether they would recommend BetaMe/Melon to others according to a 5-point Likert Scale. Of 23 invited participants, 18 participated in a digitally recorded, semistructured telephone interview. Interview data were thematically analyzed. Results: Out of the 215 participants, 198 (92%) received an initial health coaching session, and 160 (74%) were actively engaged with the program at some point during the 16-week core program. Engagement varied by demographic, with women, younger participants, and ethnic majority populations having higher rates of engagement. Usage steadily declined from 50% at Week 0 to 23% at Week 15. Participants ranked component usefulness as education resources (63.7%), health coaches (59.2%), goal tracking (48.8%), and online peer support (42.1%). Although 53% agreed that the program was easy to use, 64% would recommend the program to others. Interview participants found BetaMe/Melon useful overall, with most identifying beneficial outcomes such as increased knowledge, behavioral changes, and weight loss. Barriers to engagement were program functionality, internet connectivity, incomplete delivery of all program components, and participant motivation. Participants suggested a range of improvements to the BetaMe/Melon program. Conclusions: The program was generally well received by participants; active engagement was initially high, although it declined steadily. Maintaining participant engagement over time, individualizing programs, and addressing technical barriers are important to maximize potential health benefits from online diabetes self-management programs. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12617000549325; https://tinyurl.com/y622b27q %M 33258776 %R 10.2196/19150 %U https://www.jmir.org/2020/12/e19150 %U https://doi.org/10.2196/19150 %U http://www.ncbi.nlm.nih.gov/pubmed/33258776 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 9 %P e18896 %T Mobile Breast Cancer e-Support Program for Chinese Women With Breast Cancer Undergoing Chemotherapy (Part 3): Secondary Data Analysis %A Zhu,Haihua %A Chen,Xiuwan %A Yang,Jinqiu %A Wu,Qiaoling %A Zhu,Jiemin %A Chan,Sally Wai-Chi %+ Department of Nursing, School of Medicine, Xiamen University, Room 222, Alice Lee building, School of Medicine, Xiamen University, Xiangan Nan Road, Xiangan District, Xiamen, 361102, China, 86 15960212649, jieminzhu@xmu.edu.cn %K breast cancer %K chemotherapy %K mobile app %K mHealth %D 2020 %7 16.9.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Many app-based interventions targeting women with breast cancer have been developed and tested for effectiveness. However, information regarding the evaluation of the usage of these interventions is scarce. A better understanding of usage data is important to determine how women use apps and how these interventions affect health outcomes. Objective: This study aimed to examine the usage duration and login frequency of an app-based intervention, the Breast Cancer e-Support (BCS) program, and to investigate the association between usage data and participants’ demographic and medical characteristics. Methods: This study is a secondary data analysis of a randomized controlled trial assessing the effectiveness of the BCS program. The BCS program contains four modules: Learning Forum, Discussion Forum, Ask-the-Expert Forum, and Your Story Forum. A total of 57 women in the intervention group accessed the BCS program during their 12-week chemotherapy. The app’s background system tracked the usage duration and login frequency for each forum and the entire BCS program. Results: The total usage duration per participant ranged from 0 to 9371 minutes, and the login frequency per participant ranged from 0 to 774 times. The Discussion Forum and the Learning Forum were the most frequently used modules. The general linear model showed that age, education, family monthly income, and employment were associated with BCS usage duration and/or login frequency. Age (F1,45=10.09, P=.003, B=115.34, 95% CI 42.22-188.47) and education level (F1,45=7.22, P=.01, B=1949.63, 95% CI 487.76-3411.50) were positively associated with the usage duration of the entire BCS program. Family monthly income was positively associated with the usage duration of the Learning Forum (F1,45=11.85, P=.001, B=1488.55, 95% CI 617.58-2359.51) and the login frequency of the entire BCS program (F1,45=4.47, P=.04, B=113.68, 95% CI 5.33-222.03). Employment was negatively associated with the usage duration of the Ask-the-expert Forum (F1,45=4.50, P=.04, B=–971.87, 95% CI –1894.66 to –49.07) and the Your Story Forum (F1,45=5.36, P=.03, B=–640.71, 95% CI –1198.30 to –83.11) and positively associated with the login frequency of the entire BCS program (F1,45=10.86, P=.002, B=192.88, 95% CI 75.01-310.74). No statistical differences were found between BCS usage data and cancer stage, BMI, comorbidity, types of surgery, or cycles of chemotherapy. Conclusions: Overall, this study found considerable variability in the usage of app-based interventions. When health care professionals incorporate app-based interventions into their routine care for women with breast cancer, the learning and discussion functions of apps should be strengthened to promote engagement. Additionally, characteristics of women with breast cancer, such as age, level of education, income, and employment status, should be taken in consideration to develop tailored apps that address their particular needs and therefore improve their engagement with the app. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616000639426; http://www.ANZCTR.org.au/ACTRN12616000639426.aspx %M 32936087 %R 10.2196/18896 %U http://mhealth.jmir.org/2020/9/e18896/ %U https://doi.org/10.2196/18896 %U http://www.ncbi.nlm.nih.gov/pubmed/32936087 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 5 %N 3 %P e15219 %T Internet-Based Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Design and 6-Month Usage Results of Randomized Controlled Trial %A Harjumaa,Marja %A Absetz,Pilvikki %A Ermes,Miikka %A Mattila,Elina %A Männikkö,Reija %A Tilles-Tirkkonen,Tanja %A Lintu,Niina %A Schwab,Ursula %A Umer,Adil %A Leppänen,Juha %A Pihlajamäki,Jussi %+ VTT Technical Research Centre of Finland Ltd, Vuorimiehentie 3, Espoo, 02150, Finland, 358 044 515 94 39, marja.harjumaa@gmail.com %K digital behavior change intervention %K internet intervention %K web-based intervention %K behavior change support system %K type 2 diabetes, habit %D 2020 %7 11.8.2020 %9 Original Paper %J JMIR Diabetes %G English %X Background: Type 2 diabetes can be prevented through lifestyle changes, but sustainable and scalable lifestyle interventions are still lacking. Habit-based approaches offer an opportunity to induce long-term behavior changes. Objective: The purposes of this study were to describe an internet-based lifestyle intervention for people at risk for type 2 diabetes targeted to support formation of healthy habits and explore its user engagement during the first 6 months of a randomized controlled trial (RCT). Methods: The app provides an online store that offers more than 400 simple and contextualized habit-forming behavioral suggestions triggered by daily life activities. Users can browse, inspect, and select them; report their performances; and reflect on their own activities. Users can also get reminders, information on other users’ activities, and information on the prevention of type 2 diabetes. An unblended parallel RCT was carried out to evaluate the effectiveness of the app in comparison with routine care. User engagement is reported for the first 6 months of the trial based on the use log data of the participants, who were 18- to 70-year-old community-dwelling adults at an increased risk of type 2 diabetes. Results: Of 3271 participants recruited online, 2909 were eligible to participate in the RCT. Participants were randomized using a computerized randomization system to the control group (n=971), internet-based intervention (digital, n=967), and internet-based intervention with face-to-face group coaching (F2F+digital, n=971). Mean age of control group participants was 55.0 years, digital group 55.2 years, and F2F+digital 55.2 years. The majority of participants were female, 81.1% (787/971) in the control group, 78.3% (757/967) in the digital group, and 80.7% (784/971) in the F2F+digital group. Of the participants allocated to the digital and F2F+digital groups, 99.53% (1929/1938) logged in to the app at least once, 98.55% (1901/1938) selected at least one habit, and 95.13% (1835/1938) reported at least one habit performance. The app was mostly used on a weekly basis. During the first 6 months, the number of active users on a weekly level varied from 93.05% (1795/1929) on week 1 to 51.79% (999/1929) on week 26. The daily use activity was not as high. The digital and F2F+digital groups used the app on a median of 23.0 and 24.5 days and for 79.4 and 85.1 minutes total duration, respectively. A total of 1,089,555 habit performances were reported during the first 6 months. There were no significant differences in the use metrics between the groups with regard to cumulative use metrics. Conclusions: Results demonstrate that internet-based lifestyle interventions can be delivered to large groups including community-dwelling middle-aged and older adults, many with limited experience in digital app use, without additional user training. This intermediate analysis of use behavior showed relatively good engagement, with the percentage of active weekly users remaining over 50% at 6 months. However, we do not yet know if the weekly engagement was enough to change the lifestyles of the participants. Trial Registration: ClinicalTrials.gov NCT03156478; https://clinicaltrials.gov/ct2/show/NCT03156478 %M 32779571 %R 10.2196/15219 %U https://diabetes.jmir.org/2020/3/e15219 %U https://doi.org/10.2196/15219 %U http://www.ncbi.nlm.nih.gov/pubmed/32779571 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e16239 %T #BlackBreastsMatter: Process Evaluation of Recruitment and Engagement of Pregnant African American Women for a Social Media Intervention Study to Increase Breastfeeding %A Dauphin,Cassy %A Clark,Nikia %A Cadzow,Renee %A Saad-Harfouche,Frances %A Rodriguez,Elisa %A Glaser,Kathryn %A Kiviniemi,Marc %A Keller,Maria %A Erwin,Deborah %+ Cancer Prevention and Control, Roswell Park Comprehensive Cancer Center, Elm and Carlton Streets, Buffalo, NY, 14263, United States, 1 716 845 2927, deborah.erwin@roswellpark.org %K breastfeeding %K breast cancer education %K African American mothers %K Facebook %K mobile phone, social media %D 2020 %7 10.8.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: In the United States, there are lower rates of breastfeeding among African American mothers, particularly those who are younger women. Recent epidemiological studies have shown a strong association of more aggressive types of breast cancer (estrogen receptor negative) among African American women, with a higher risk in African American women who did not breastfeed their children. Objective: This study aims to describe the process evaluation of recruitment and educational strategies to engage pregnant African American participants for a pilot study designed to determine whether social media messaging about breast cancer risk reduction through breastfeeding may positively influence breastfeeding rates. Methods: This pilot study is conducted in collaboration with a local Women, Infants, and Children (WIC) organization and hospital and prenatal clinics of a local health care network. To engage African American women to enroll in the study, several methods and monitoring processes were explored, including WIC electronic text-based messages sent out to all phones of current WIC recipients (referred to as e-blasts); keyword responses to texts from flyers and posters in local community-based organizations, hospitals, and prenatal clinics; keyword responses using electronic links posted in established Facebook groups; and snowball recruitment of other pregnant women by current participants through Facebook. Once enrolled, participants were randomized to 2 study conditions: (1) an intervention group receiving messages about breast cancer risk reduction and breastfeeding or (2) a control group receiving breastfeeding-only messages. Data were obtained through electronic monitoring, SurveyMonkey, qualitative responses on Facebook, focus groups, and interviews. Results: More than 3000 text messages were sent and received through WIC e-blasts and keyword responses from flyers. A total of 472 women were recruited through WIC e-blast, and 161 responded to flyers and contacts through the local health care network, community-based organizations, Facebook, and friend referrals. A total of 633 women were assessed for eligibility to participate in the study. A total of 288 pregnant African American women were enrolled, consented, and completed presurvey assessments (102.8% of the goal), and 22 participants attended focus groups or interviews reporting on their experiences with Facebook and the educational messages. Conclusions: This process evaluation suggests that using electronic, smartphone apps with social media holds promise for both recruitment and conduct of health education intervention studies for pregnant African American women. Providing messaging and resources through social media to reinforce and educate women about breastfeeding and potentially provide lactation support is intriguing. Convenience (for researchers and participants) is an attribute of social media for this demographic of women and worthy of further research as an educational tool. Trial Registration: ClinicalTrials.gov NCT03680235; https://clinicaltrials.gov/ct2/show/NCT03680235 %M 32773377 %R 10.2196/16239 %U https://www.jmir.org/2020/8/e16239 %U https://doi.org/10.2196/16239 %U http://www.ncbi.nlm.nih.gov/pubmed/32773377 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e14822 %T Dose-Response Relationship of a Web-Based Tailored Intervention Promoting Human Papillomavirus Vaccination: Process Evaluation of a Randomized Controlled Trial %A Pot,Mirjam %A Paulussen,Theo GWM %A Ruiter,Robert AC %A Mollema,Liesbeth %A Hofstra,Miranda %A Van Keulen,Hilde M %+ Child Health, Netherlands Organization for Applied Scientific Research (TNO), Schipholweg 77, Leiden, 2316ZL, Netherlands, 31 643234293, mirjampot90@gmail.com %K HPV vaccination %K web-based tailored intervention %K process evaluation %K intervention use %K dose-response relationship %K randomized controlled trial %K informed decision making %D 2020 %7 17.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: In the Netherlands, human papillomavirus (HPV) vaccination uptake remains low. To improve informed decision making (IDM) and HPV vaccination acceptability, we systematically developed an interactive, web-based tailored intervention to which mothers of Dutch girls were invited to participate. Objective: The aim of this study was to provide insight into the intervention’s working mechanisms by evaluating (1) program use, (2) program acceptability, and (3) the relationship of program use with program acceptability and intervention effects (ie, dose-response relationship). Methods: Only mothers from the intervention arm of a randomized controlled trial that assessed the effectiveness of the web-based, tailored intervention were included in this study. They were invited to visit the website of the web-based intervention between baseline (January 2015, just before access to the intervention) and follow up (March 2015, prior to the first HPV vaccination). Indicators for program use were time of website use (ie, duration of intervention exposure) and completeness (ie, proportion of all available web pages visited). HPV vaccination uptake registered by Praeventis was used as the primary outcome. Secondary outcomes were IDM, decisional conflict, and social-psychological determinants of HPV vaccination uptake. Results: Among the 3995 invited mothers, 2509 (62.80%) logged on to the website, 2239 of whom (89.24%) visited at least one page of the intervention components. On average, mothers spent 21.39 minutes (SD 12.41) on the website and completed 50.04% (SD 26.18%) of the website components. Participants rated the website 7.64 (SD 1.39) on a 10-point scale. Program acceptability was significantly associated with completeness (β=4.36, P<.001), but not with time of website use (β=–.07, P=.77). Intention-to-treat analysis (N=3995) showed a significant positive effect of completeness on all outcome measures (all P<.003; Bonferroni-corrected α=.05/15 factors), including on HPV vaccination uptake. Time of website use had a significant positive effect on all outcomes (all P<.003), except for uptake (P=.20), risk perception when not vaccinated (P=.14), subjective norms (P=.03), and habit (P=.01). Conclusions: Program use and acceptability of the intervention were adequate. Completeness was positively associated with acceptability. Furthermore, positive effects (ie, dose-response effects) were found for completeness and time of website use on the mothers’ IDM, decisional conflict, and almost all of the social-psychological determinants of HPV vaccination acceptability. In addition, the extent to which mothers completed the intervention had a positive impact on their daughters’ vaccination uptake. This indicates that the web-based, tailored intervention fits well with the mothers’ needs, and that completeness of use is essential for improving HPV vaccination uptake, acceptability, and IDM. Program use should therefore be promoted. Trial Registration: Netherlands Trial Register NTR4795; https://www.trialregister.nl/trial/4795 %M 32520718 %R 10.2196/14822 %U https://www.jmir.org/2020/7/e14822 %U https://doi.org/10.2196/14822 %U http://www.ncbi.nlm.nih.gov/pubmed/32520718 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 7 %P e19734 %T Use of an Unguided, Web-Based Distress Self-Management Program After Breast Cancer Diagnosis: Sub-Analysis of CaringGuidance Pilot Study %A Lally,Robin M %A Kupzyk,Kevin %A Gallo,Steve %A Berry,Donna %+ College of Nursing, Fred & Pamela Buffett Cancer Center, University of Nebraska Medical Center, UNMC College of Nursing Center For Nursing Science, 985330 Nebraska Medical Center, Omaha, NE, 68198-0001, United States, 1 4025595464, robin.lally@unmc.edu %K eHealth %K psychoeducation %K supportive oncology %K distress %K self-management %K oncology %K breast cancer %D 2020 %7 6.7.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Unguided, web-based psychoeducational interventions are gaining interest as a way to reach patients while reducing pressure on clinical resources. However, there has been little research on how patients with cancer use these interventions. Objective: The objective of this analysis was to evaluate how women newly diagnosed with breast cancer used the unguided web-based, psychoeducational distress self-management program CaringGuidance After Breast Cancer Diagnosis while enrolled in a pilot feasibility study. Methods: Women with stage 0 to II breast cancer diagnosed within the prior three months were recruited from clinics primarily in the Northeastern United States for participation in a 12-week pilot study of CaringGuidance plus usual care versus usual care alone. Usage prompts included sets of emails sent weekly for 12 weeks; standardized congratulatory emails after every two hours of program use, and informative emails for each cognitive-behavioral exercise. Individual user activity on the site was automatically tracked by an analytics system and recorded directly in the CaringGuidance database. Results: Complete usage data were available for 54 subjects. Ninety-eight percent of the intervention group logged into CaringGuidance independently at least once. Thirty-eight (70%) logged in during all three months, 15 (28%) were intermittent users, and one (2%) was a non-user. Users (n=53) averaged 15.6 (SD 9.85) logins. Mean logins were greatest in month 1 (7.26, SD 4.02) and declined in months 2 (4.32, SD 3.66) and month 3 (4.02, SD 3.82). Eleven (21%) used CaringGuidance with both the frequency and activity level intended at study outset, 9 (17%) exceeded intended frequency and activity (high-high users), and 10 (19%) were below expected usage on both login frequency and activity (low-low users). Low-low users and high-high users differed significantly (P<.001) in the total number of views and unique views of all program components. Change in depressive symptoms and the number of sessions (r=.351) and logins (r=.348) between study months 1 and 2 were significantly correlated (P=.018, .019). Higher baseline distress was associated with more unique views of program resources (r=.281, P=.043). Change in intrusive/avoidant thoughts from baseline to month 3, and the number of users’ unique exercise views were negatively correlated (r=–.319, P=.035) so that more unique exercise views, equated with greater decline in intrusive/avoidant thoughts from baseline to month 3. Conclusions: These findings favor the hypothesis that the key ingredient is not the amount of program use, but each user’s self-selected activity within the program. More research is needed on the ideal ways to maintain use, and capture and define engagement and enactment of behaviors by people with cancer accessing unguided, self-management web-based programs. %M 32628117 %R 10.2196/19734 %U https://www.jmir.org/2020/7/e19734 %U https://doi.org/10.2196/19734 %U http://www.ncbi.nlm.nih.gov/pubmed/32628117 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 7 %N 3 %P e18171 %T Process Evaluation of an eHealth Intervention (Food4toddlers) to Improve Toddlers' Diet: Randomized Controlled Trial %A Røed,Margrethe %A Vik,Frøydis Nordgård %A Hillesund,Elisabet Rudjord %A Van Lippevelde,Wendy %A Medin,Anine Christine %A Øverby,Nina Cecilie %+ Department of Nutrition and Public Health, Faculty of Health and Sports Sciences, University of Agder, PO Box 422, Kristiansand, 4604, Norway, 47 38141324, nina.c.overby@uia.no %K toddler %K mHealth %K usability %K eHealth %K diet intervention %K digital intervention %K education difference %D 2020 %7 6.7.2020 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Parents seek trustworthy information online to promote healthy eating for their toddlers. Such information must be perceived as relevant and easy to implement and use. Objective: The objectives of this study were to conduct a process evaluation of the electronic health (eHealth) intervention (Food4toddlers) targeting food environment, parental feeding practices, and toddlers’ diet and to examine possible differences in these areas according to education and family composition. Methods: A 2-armed randomized controlled trial, including 298 parent–toddler dyads from Norway, was conducted in 2017. In total, 148 parents in the intervention group received access to an intervention website for 6 months. Data on website usage were retrieved from the learning management platform used (NEO). Participants’ satisfaction with the intervention was asked for in a postintervention questionnaire. Chi-square and t tests were used to examine differences in usage and satisfaction between education and family composition groups. Results: Most participants were mothers (144/148, 97.2%), lived in two-adult households (148/148, 100%), and were born in Norway (132/148, 89.1%). Mean parental age was 31.5 years (SD 4.2). More than 87.8% (129/147) had a university education degree and 56.5% (83/147) had over 4 years of university education. Most (128/148, 86.5%) intervention participants entered the website at least once (mean days of access 7.4 [SD 7.1]). Most parents reported the website as appropriate to the child’s age (71/83, 86%) and self-explanatory (79/83, 95%) and appreciated the interface (52/83, 63%) and layout (46/83, 55%). In total, 61% (51/83) stated that they learned something new from the intervention. Parents with over 4 years of university education and in 1-child households used the intervention website more than those with 4 years or less of university education (8.4 vs 5.9 days in total, P=.04) and households with more than 1 child (8.3 vs 5.8 days in total, P=.04), respectively. Conclusions: The Food4toddlers intervention website was found to be relevant by most participants in the intervention group, although usage of the website differed according to educational level and family composition. For eHealth interventions to be effective, intervention materials such as websites must be used by the target group. Our results highlight the need to include users from different groups when developing interventions. Trial Registration: ISRCTN Registry ISRCTN92980420; http://www.isrctn.com/ISRCTN92980420 %M 32628612 %R 10.2196/18171 %U https://humanfactors.jmir.org/2020/3/e18171 %U https://doi.org/10.2196/18171 %U http://www.ncbi.nlm.nih.gov/pubmed/32628612 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 6 %P e20513 %T Acceptability and Utility of an Open-Access, Online Single-Session Intervention Platform for Adolescent Mental Health %A Schleider,Jessica Lee %A Dobias,Mallory %A Sung,Jenna %A Mumper,Emma %A Mullarkey,Michael C %+ Department of Psychology, Stony Brook University, Psychology-B 340, Stony Brook, NY, 11794-2500, United States, 1 9174391872, jessica.schleider@stonybrook.edu %K internet intervention %K online interventions %K youth %K mental health %K adolescent %K depression %K single-session intervention %K intervention %D 2020 %7 30.6.2020 %9 Original Paper %J JMIR Ment Health %G English %X Background: Many youths with mental health needs are unable to access care. Single-session interventions (SSIs) have helped reduce youth psychopathology across multiple trials, promising to broaden access to effective, low-intensity supports. Online, self-guided SSIs may be uniquely scalable, particularly if they are freely available for as-needed use. However, the acceptability of online SSI and their efficacy have remained unexamined outside of controlled trials, and their practical utility is poorly understood. Objective: We evaluated the perceived acceptability and proximal effects of Project YES (Youth Empowerment & Support), an open-access platform offering three online SSIs for youth internalizing distress. Methods: After selecting one of three SSIs to complete, participants (ages 11-17 years) reported pre- and post-SSI levels of clinically relevant outcomes that SSIs may target (eg, hopelessness, self-hate) and perceived SSI acceptability. User-pattern variables, demographics, and depressive symptoms were collected to characterize youths engaging with YES. Results: From September 2019 through March 2020, 694 youths accessed YES, 539 began, and 187 completed a 30-minute, self-guided SSI. SSI completers reported clinically elevated depressive symptoms, on average, and were diverse on several dimensions (53.75% non-white; 78.10% female; 43.23% sexual minorities). Regardless of SSI selection, completers reported pre- to post-program reductions in hopelessness (dav=0.53; dz=0.71), self-hate (dav=0.32; dz=0.61), perceived control (dav=0.60; dz=0.72) and agency (dav=0.39; dz=0.50). Youths rated all SSIs as acceptable (eg, enjoyable, likely to help peers). Conclusions: Results support the perceived acceptability and utility of open-access, free-of-charge SSIs for youth experiencing internalizing distress. Trial Registration: Open Science Framework; osf.io/e52p3 %M 32602846 %R 10.2196/20513 %U http://mental.jmir.org/2020/6/e20513/ %U https://doi.org/10.2196/20513 %U http://www.ncbi.nlm.nih.gov/pubmed/32602846 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 8 %P e12775 %T Exploring the Relationship Between Usage and Outcomes of an Internet-Based Intervention for Individuals With Depressive Symptoms: Secondary Analysis of Data From a Randomized Controlled Trial %A Enrique,Angel %A Palacios,Jorge E %A Ryan,Holly %A Richards,Derek %+ E-mental Health Research Group, School of Psychology, University of Dublin Trinity College, Dublin, 2, Ireland, 353 1 554 9771, enriquea@tcd.ie %K Web-based intervention %K depression %K adherence %K engagement %K eHealth %K internet %D 2019 %7 01.08.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Internet interventions can easily generate objective data about program usage. Increasingly, more studies explore the relationship between usage and outcomes, but they often report different metrics of use, and the findings are mixed. Thus, current evaluations fail to demonstrate which metrics should be considered and how these metrics are related to clinically meaningful change. Objective: This study aimed to explore the relationship between several usage metrics and outcomes of an internet-based intervention for depression. Methods: This is a secondary analysis of data from a randomized controlled trial that examined the efficacy of an internet-based cognitive behavioral therapy for depression (Space from Depression) in an adult community sample. All participants who enrolled in the intervention, regardless of meeting the inclusion criteria, were included in this study. Space from Depression is a 7-module supported intervention, delivered over a period of 8 weeks. Different usage metrics (ie, time spent, modules and activities completed, and percentage of program completion) were automatically collected by the platform, and composite variables from these (eg, activities per session) were computed. A breakdown of the usage metrics was obtained by weeks. For the analysis, the sample was divided into those who obtained a reliable change (RC)—and those who did not. Results: Data from 216 users who completed pre- and posttreatment outcomes were included in the analyses. A total of 89 participants obtained an RC, and 127 participants did not obtain an RC. Those in the RC group significantly spent more time, had more log-ins, used more tools, viewed a higher percentage of the program, and got more reviews from their supporter compared with those who did not obtain an RC. Differences between groups in usage were observed from the first week in advance across the different metrics, although they vanished over time. In the RC group, the usage was higher during the first 4 weeks, and then a significant decrease was observed. Our results showed that specific levels of platform usage, 7 hours total time spent, 15 sessions, 30 tools used, and 50% of program completion, were associated with RC. Conclusions: Overall, the results showed that those individuals who obtained an RC after the intervention had higher levels of exposure to the platform. The usage during the first half of the intervention was higher, and differences between groups were observed from the first week. This study also showed specific usage levels associated with outcomes that could be tested in controlled studies to inform the minimal usage to establish adherence. These results will help to better understand how to use internet-based interventions and what optimal level of engagement can most affect outcomes. Trial Registration: ISRCTN Registry ISRCTN03704676; http://www.isrctn.com/ISRCTN03704676 International Registered Report Identifier (IRRID): RR2-10.1186/1471-244X-14-147 %M 31373272 %R 10.2196/12775 %U https://www.jmir.org/2019/8/e12775/ %U https://doi.org/10.2196/12775 %U http://www.ncbi.nlm.nih.gov/pubmed/31373272 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 6 %N 7 %P e12707 %T Unraveling the Black Box: Exploring Usage Patterns of a Blended Treatment for Depression in a Multicenter Study %A Kemmeren,Lise L %A van Schaik,Anneke %A Smit,Johannes H %A Ruwaard,Jeroen %A Rocha,Artur %A Henriques,Mário %A Ebert,David Daniel %A Titzler,Ingrid %A Hazo,Jean-Baptiste %A Dorsey,Maya %A Zukowska,Katarzyna %A Riper,Heleen %+ Department of Research and Innovation, GGZ inGeest Specialized Mental Health Care, Oldenaller 1, Amsterdam, 1081 HJ, Netherlands, 31 207884527, l.kemmeren@ggzingeest.nl %K cognitive behavior therapy %K internet %K combined modality therapy %K depression %K routine mental healthcare %K treatment compliance %K logfile analysis %D 2019 %7 25.07.2019 %9 Original Paper %J JMIR Ment Health %G English %X Background: Blended treatments, combining digital components with face-to-face (FTF) therapy, are starting to find their way into mental health care. Knowledge on how blended treatments should be set up is, however, still limited. To further explore and optimize blended treatment protocols, it is important to obtain a full picture of what actually happens during treatments when applied in routine mental health care. Objective: The aims of this study were to gain insight into the usage of the different components of a blended cognitive behavioral therapy (bCBT) for depression and reflect on actual engagement as compared with intended application, compare bCBT usage between primary and specialized care, and explore different usage patterns. Methods: Data used were collected from participants of the European Comparative Effectiveness Research on Internet-Based Depression Treatment project, a European multisite randomized controlled trial comparing bCBT with regular care for depression. Patients were recruited in primary and specialized routine mental health care settings between February 2015 and December 2017. Analyses were performed on the group of participants allocated to the bCBT condition who made use of the Moodbuster platform and for whom data from all blended components were available (n=200). Included patients were from Germany, Poland, the Netherlands, and France; 64.5% (129/200) were female and the average age was 42 years (range 18-74 years). Results: Overall, there was a large variability in the usage of the blended treatment. A clear distinction between care settings was observed, with longer treatment duration and more FTF sessions in specialized care and a more active and intensive usage of the Web-based component by the patients in primary care. Of the patients who started the bCBT, 89.5% (179/200) also continued with this treatment format. Treatment preference, educational level, and the number of comorbid disorders were associated with bCBT engagement. Conclusions: Blended treatments can be applied to a group of patients being treated for depression in routine mental health care. Rather than striving for an optimal blend, a more personalized blended care approach seems to be the most suitable. The next step is to gain more insight into the clinical and cost-effectiveness of blended treatments and to further facilitate uptake in routine mental health care. %M 31344670 %R 10.2196/12707 %U http://mental.jmir.org/2019/7/e12707/ %U https://doi.org/10.2196/12707 %U http://www.ncbi.nlm.nih.gov/pubmed/31344670 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 6 %P e13965 %T A Mobility-Focused Knowledge Translation Randomized Controlled Trial to Improve Physical Activity: Process Evaluation of the Move4Age Study %A Neil-Sztramko,Sarah E %A Smith-Turchyn,Jenna %A Richardson,Julie %A Dobbins,Maureen %+ School of Nursing, McMaster University, 175 Longwood Road South, Suite 210a, Hamilton, ON, L8P0A1, Canada, 1 9055259140 ext 20459, neilszts@mcmaster.ca %K process evaluation %K physical activity %K health information %K mobility %K older adults %K knowledge translation %D 2019 %7 20.06.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Maintaining physical activity and physical function is important for healthy aging. We recently completed a randomized controlled trial of a targeted knowledge translation (KT) intervention delivered through the McMaster Optimal Aging Portal with the goal to increase physical activity and physical mobility in middle-aged and older adults, with results reported elsewhere. Objective: The purpose of this process evaluation study is to explore which KT strategies were used by both intervention and control group participants, as well as the intervention groups’ engagement, satisfaction, and perceived usefulness of the targeted KT intervention. Methods: Data on engagement with the intervention materials were gathered quantitatively through Google Analytics and Hootsuite throughout the intervention. Qualitative data were collected through a combination of open-ended surveys and qualitative interviews with a subset of participants at the end of the study to further understand engagement, satisfaction, and usefulness of the KT strategies. Results: Throughout the intervention period, engagement with content delivered through weekly emails was highest, and participants rated email content most favorably in both surveys and interviews. Participants were generally satisfied with the intervention, noting the ease of participating and the distillation of information in an easy-to-access format being beneficial features. Participants who did not find the intervention useful were those with already high levels of baseline physical activity or physical function and those who were looking for more specific or individualized content. Conclusions: This process evaluation provides insight into our randomized controlled trial findings and provides information that can be used to improve future online KT interventions. Trial Registration: ClinicalTrials.gov NCT02947230; https://clinicaltrials.gov/ct2/show/nct02947230 (Archived by WebCite at http://www.webcitation.org/78t4tR8tM) %M 31223121 %R 10.2196/13965 %U http://www.jmir.org/2019/6/e13965/ %U https://doi.org/10.2196/13965 %U http://www.ncbi.nlm.nih.gov/pubmed/31223121 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 6 %P e14022 %T A Pragmatic Cluster Randomized Trial of an Electronic Clinical Decision Support System to Improve Chronic Kidney Disease Management in Primary Care: Design, Rationale, and Implementation Experience %A Khoong,Elaine C %A Karliner,Leah %A Lo,Lowell %A Stebbins,Marilyn %A Robinson,Andrew %A Pathak,Sarita %A Santoyo-Olsson,Jasmine %A Scherzer,Rebecca %A Peralta,Carmen A %+ Division of General Internal Medicine at Zuckerberg San Francisco General Hospital, Department of Medicine, University of California San Francisco, Ward 13, Building 10, Floor 3, 1001 Potrero Avenue, San Francisco, CA, 94110, United States, 1 4152063188, elaine.khoong@ucsf.edu %K chronic kidney disease %K clinical decision support systems %K pragmatic clinical trial %K electronic health records %D 2019 %7 7.6.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: The diagnosis of chronic kidney disease (CKD) is based on laboratory results easily extracted from electronic health records; therefore, CKD identification and management is an ideal area for targeted electronic decision support efforts. Early CKD management frequently occurs in primary care settings where primary care providers (PCPs) may not implement all the best practices to prevent CKD-related complications. Few previous studies have employed randomized trials to assess a CKD electronic clinical decision support system (eCDSS) that provided recommendations to PCPs tailored to each patient based on laboratory results. Objective: The aim of this study was to report the trial design and implementation experience of a CKD eCDSS in primary care. Methods: This was a 3-arm pragmatic cluster-randomized trial at an academic general internal medicine practice. Eligible patients had 2 previous estimated-glomerular-filtration-rates by serum creatinine (eGFRCr) <60 mL/min/1.73m2 at least 90 days apart. Randomization occurred at the PCP level. For patients of PCPs in either of the 2 intervention arms, the research team ordered triple-marker testing (serum creatinine, serum cystatin-c, and urine albumin-creatinine-ratio) at the beginning of the study period, to be completed when acquiring labs for regular clinical care. The eCDSS launched for PCPs and patients in the intervention arms during a regular PCP visit subsequent to completing the triple-marker testing. The eCDSS delivered individualized guidance on cardiovascular risk-reduction, potassium and proteinuria management, and patient education. Patients in the eCDSS+ arm also received a pharmacist phone call to reinforce CKD-related education. The primary clinical outcome is blood pressure change from baseline at 6 months after the end of the trial, and the main secondary outcome is provider awareness of CKD diagnosis. We also collected process, patient-centered, and implementation outcomes. Results: A multidisciplinary team (primary care internist, nephrologists, pharmacist, and informaticist) designed the eCDSS to integrate into the current clinical workflow. All 81 PCPs contacted agreed to participate and were randomized. Of 995 patients initially eligible by eGFRCr, 413 were excluded per protocol and 58 opted out or withdrew, resulting in 524 patient participants (188 usual care; 165 eCDSS; and 171 eCDSS+). During the 12-month intervention period, 53.0% (178/336) of intervention patient participants completed triple-marker labs. Among these, 138/178 (77.5%) had a PCP appointment after the triple-marker labs resulted; the eCDSS was opened for 73.9% (102/138), with orders or education signed for 81.4% (83/102). Conclusions: Successful integration of an eCDSS into primary care workflows and high eCDSS utilization rates at eligible visits suggest this tailored electronic approach is feasible and has the potential to improve guideline-concordant CKD care. Trial Registration: ClinicalTrials.gov NCT02925962; https://clinicaltrials.gov/ct2/show/NCT02925962 (Archived by WebCite at http://www.webcitation.org/78qpx1mjR) International Registered Report Identifier (IRRID): DERR1-10.2196/14022 %M 31199334 %R 10.2196/14022 %U http://www.researchprotocols.org/2019/6/e14022/ %U https://doi.org/10.2196/14022 %U http://www.ncbi.nlm.nih.gov/pubmed/31199334 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 6 %P e13290 %T Outcomes and Device Usage for Fully Automated Internet Interventions Designed for a Smartphone or Personal Computer: The MobileQuit Smoking Cessation Randomized Controlled Trial %A Danaher,Brian G %A Tyler,Milagra S %A Crowley,Ryann C %A Brendryen,Håvar %A Seeley,John R %+ Prevention Science Institute, University of Oregon, 1600 Millrace Dr, Eugene, OR, 97403, United States, 1 5413464490, bdanaher@uoregon.edu %K tobacco %K smoking %K internet %K eHealth %K mHealth %K smartphone %K device %D 2019 %7 06.06.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Many best practice smoking cessation programs use fully automated internet interventions designed for nonmobile personal computers (desktop computers, laptops, and tablets). A relatively small number of smoking cessation interventions have been designed specifically for mobile devices such as smartphones. Objective: This study examined the efficacy and usage patterns of two internet-based best practices smoking cessation interventions. Methods: Overall, 1271 smokers who wanted to quit were randomly assigned to (1) MobileQuit (designed for—and constrained its use to—mobile devices, included text messaging, and embodied tunnel information architecture) or (2) QuitOnline (designed for nonmobile desktop or tablet computers, did not include text messages, and used a flexible hybrid matrix-hierarchical information architecture). Primary outcomes included self-reported 7-day point-prevalence smoking abstinence at 3- and 6-month follow-up assessments. Program visits were unobtrusively assessed (frequency, duration, and device used for access). Results: Significantly more MobileQuit participants than QuitOnline participants reported quitting smoking. Abstinence rates using intention-to-treat analysis were 20.7% (131/633) vs 11.4% (73/638) at 3 months, 24.6% (156/633) vs 19.3% (123/638) at 6 months, and 15.8% (100/633) vs 8.8% (56/638) for both 3 and 6 months. Using Complete Cases, MobileQuit’s advantage was significant at 3 months (45.6% [131/287] vs 28.4% [73/257]) and the combined 3 and 6 months (40.5% [100/247] vs 25.9% [56/216]) but not at 6 months (43.5% [156/359] vs 34.4% [123/329]). Participants in both conditions reported their program was usable and helpful. MobileQuit participants visited their program 5 times more frequently than did QuitOnline participants. Consistent with the MobileQuit’s built-in constraint, 89.46% (8820/9859) of its visits were made on an intended mobile device, whereas 47.72% (691/1448) of visits to QuitOnline used an intended nonmobile device. Among MobileQuit participants, 76.0% (459/604) used only an intended mobile device, 23.0% (139/604) used both mobile and nonmobile devices, and 0.1% (6/604) used only a nonmobile device. Among QuitOnline participants, 31.3% (137/438) used only the intended nonmobile devices, 16.7% (73/438) used both mobile and nonmobile devices, and 52.1% (228/438) used only mobile devices (primarily smartphones). Conclusions: This study provides evidence for optimizing intervention design for smartphones over a usual care internet approach in which interventions are designed primarily for use on nonmobile devices such as desktop computers, laptops. or tablets. We propose that future internet interventions should be designed for use on all of the devices (multiple screens) that users prefer. We forecast that the approach of designing internet interventions for mobile vs nonmobile devices will be replaced by internet interventions that use a single Web app designed to be responsive (adapt to different screen sizes and operating systems), share user data across devices, embody a pervasive information architecture, and complemented by text message notifications. Trial Registration: ClinicalTrials.gov NCT01952236; https://clinicaltrials.gov/ct2/show/NCT01952236 (Archived by WebCite at http://www.webcitation.org/6zdSxqbf8) %M 31172967 %R 10.2196/13290 %U https://www.jmir.org/2019/6/e13290/ %U https://doi.org/10.2196/13290 %U http://www.ncbi.nlm.nih.gov/pubmed/31172967 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 5 %P e12044 %T Evaluating a Video-Based, Personalized Webpage in Genitourinary Oncology Clinical Trials: A Phase 2 Randomized Trial %A McKay,Rana %A Mills,Hannah %A Werner,Lillian %A Choudhury,Atish %A Choueiri,Toni %A Jacobus,Susanna %A Pace,Amanda %A Polacek,Laura %A Pomerantz,Mark %A Prisby,Judith %A Sweeney,Christopher %A Walsh,Meghara %A Taplin,Mary-Ellen %+ Department of Medical Oncology, Dana-Farber Cancer Institute, 450 Brookline Avenue, Dana 1230, Boston, MA, 02215, United States, 1 (617) 582 7221, Mary_Taplin@dfci.harvard.edu %K cancer %K prostatic neoplasms %K kidney neoplasms %K clinical trial %K instructional films and videos %K education %D 2019 %7 02.05.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: The pace of drug discovery and approvals has led to expanding treatments for cancer patients. Although extensive research exists regarding barriers to enrollment in oncology clinical trials, there are limited studies evaluating processes to optimize patient education, oral anticancer therapy administration, and adherence for patients enrolled in clinical trials. In this study, we assess the feasibility of a video-based, personalized webpage for patients enrolled in genitourinary oncology clinical trials involving 1 or more oral anticancer therapy. Objective: The primary objective of this trial was to assess the differences in the number of patient-initiated violations in the intervention arm compared with a control arm over 4 treatment cycles. Secondary objectives included patient satisfaction, frequently asked questions by patients on the intervention arm, patient-initiated calls to study team members, and patient-reported stress levels. Methods: Eligible patients enrolling on a therapeutic clinical trial for a genitourinary malignancy were randomized 2:1 to the intervention arm or control arm. Patients randomized to the intervention arm received access to a video-based, personalized webpage, which included videos of patients’ own clinic encounters with their providers, instructional videos on medication administration and side effects, and electronic versions of educational documents. Results: A total of 99 patients were enrolled (89 were evaluable; 66 completed 4 cycles). In total, 71% (40/56) of patients in the intervention arm had 1 or more patient-initiated violation compared with 70% (23/33) in the control arm. There was no difference in the total number of violations across 4 cycles between the 2 arms (estimate=−0.0939, 95% CI−0.6295 to 0.4418, P value=.73). Median baseline satisfaction scores for the intervention and control arms were 72 and 73, respectively, indicating high levels of patient satisfaction in both arms. Median baseline patient-reported stress levels were 10 and 13 for the intervention and control arms, respectively, indicating low stress levels in both arms at baseline. Conclusions: This study is among the first to evaluate a video-based, personalized webpage that provides patients with educational videos and video recordings of clinical trial appointments. Despite not meeting the primary endpoint of reduced patient-initiated violations, this study demonstrates the feasibility of a video-based, personalized webpage in clinical trials. Future research assessing this tool might be better suited for realms outside of clinical trials and might consider the use of an endpoint that assesses patient-reported outcomes directly. A major limitation of this study was the lack of prior data for estimating the null hypothesis in this population. %M 31045501 %R 10.2196/12044 %U https://www.jmir.org/2019/5/e12044/ %U https://doi.org/10.2196/12044 %U http://www.ncbi.nlm.nih.gov/pubmed/31045501 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 4 %P e13204 %T Usage Patterns of GlucoNote, a Self-Management Smartphone App, Based on ResearchKit for Patients With Type 2 Diabetes and Prediabetes %A Yamaguchi,Satoko %A Waki,Kayo %A Nannya,Yasuhito %A Nangaku,Masaomi %A Kadowaki,Takashi %A Ohe,Kazuhiko %+ Department of Ubiquitous Health Informatics, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan, 81 3 5800 9129, kwaki-tky@umin.ac.jp %K telemedicine %K mHealth %K self-management %K diabetes mellitus %D 2019 %7 24.04.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Preventing progression from prediabetes to diabetes—or slowing the progression of diabetes—is an urgent task worldwide. Previous studies have shown that mobile health (mHealth) may powerfully support self-management for patients with type 2 diabetes. Certainly, mHealth improves health care efficiency and gives patients convenient access to self-management of their own health. Many health care apps are available right now, and their use in clinical studies with large-scale real-life data is expected. However, the usage patterns of those apps—especially in the absence of intervention by medical professionals—remain unknown. Objective: We developed GlucoNote, an app that uses Apple’s ResearchKit to support self-management for patients with type 2 diabetes and prediabetes; the app does not require prescription or intervention by medical professionals. We evaluated its usage patterns via a remotely conducted study. Methods: iPhone users across Japan who have type 2 diabetes or prediabetes were free to download GlucoNote and to participate in the study after they provided consent electronically on the app. The 522 users who enrolled in the study within 1 year of its release were analyzed. We analyzed the retention rates of 357 participants who recorded at least 1 of 4 items—body weight, blood sugar, blood pressure, or dietary information. Characteristics of participants who used GlucoNote longer than 4 weeks (robust users) were compared with those of participants who did not (nonrobust users). The changes among robust users were evaluated. Results: The median observation and retention durations were 382 days (interquartile range [IQR] 275-423) and 8 days (IQR 1-63), respectively. The retention rates for 2 days and for 4, 8, and 12 weeks were 0.627 (95% CI 0.575-0.675), 0.353 (0.304-0.403), 0.272 (0.227-0.319), and 0.220 (0.179-0.265), respectively. Men were more likely to be robust users than women (P=.02). At week 0, robust users were more likely than nonrobust users to have a higher daily energy intake (median 1595 [IQR 1198-1788] kcal vs 1451 [IQR 769-1657] kcal; P=.04) and have higher daily step counts (median 6108 [IQR 3797-9227] vs 5171 [IQR 2885-7258]; P=.001). Among robust users, body weight decreased from weeks 0 to 4 (mean 71.3 [SD 14.1] kg to 70.8 [SD 13.9] kg; P=.002) by mean 0.6% (SD 1.6). Conclusions: GlucoNote offered a valuable opportunity to evaluate usage patterns of apps. Future challenges include improving low retention rates and evaluating their effects. %M 31017586 %R 10.2196/13204 %U http://mhealth.jmir.org/2019/4/e13204/ %U https://doi.org/10.2196/13204 %U http://www.ncbi.nlm.nih.gov/pubmed/31017586 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 8 %P e10003 %T Effect and Process Evaluation of a Smartphone App to Promote an Active Lifestyle in Lower Educated Working Young Adults: Cluster Randomized Controlled Trial %A Simons,Dorien %A De Bourdeaudhuij,Ilse %A Clarys,Peter %A De Cocker,Katrien %A Vandelanotte,Corneel %A Deforche,Benedicte %+ Unit Health Promotion and Education, Department of Public Health, Ghent University, Corneel Heymanslaan 10, Entrance 42 (K3), Ghent, 9000, Belgium, 32 498457442, dorien.simons@ugent.be %K mHealth %K mobile apps %K active transport %K Fitbit %K accelerometers %K mobile phone %K emerging adulthood %K physical activity intervention %K health promotion %D 2018 %7 24.08.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mobile technologies have great potential to promote an active lifestyle in lower educated working young adults, an underresearched target group at a high risk of low activity levels. Objective: The objective of our study was to examine the effect and process evaluation of the newly developed evidence- and theory-based smartphone app “Active Coach” on the objectively measured total daily physical activity; self-reported, context-specific physical activity; and self-reported psychosocial variables among lower educated working young adults. Methods: We recruited 130 lower educated working young adults in this 2-group cluster randomized controlled trial and assessed outcomes at baseline, posttest (baseline+9 weeks), and follow-up (posttest+3 months). Intervention participants (n=60) used the Active Coach app (for 9 weeks) combined with a Fitbit activity tracker. Personal goals, practical tips, and educational facts were provided to encourage physical activity. The control group received print-based generic physical activity information. Both groups wore accelerometers for objective measurement of physical activity, and individual interviews were conducted to assess the psychosocial variables and context-specific physical activity. Furthermore, intervention participants were asked process evaluation questions and generalized linear mixed models and descriptive statistics were applied. Results: No significant intervention effects were found for objectively measured physical activity, self-reported physical activity, and self-reported psychosocial variables (all P>.05). Intervention participants evaluated the Active Coach app and the combined use with the Fitbit wearable as self-explanatory (36/51, 70.6%), user friendly (40/51, 78.4%), and interesting (34/51, 66.7%). Throughout the intervention, we observed a decrease in the frequency of viewing graphical displays in the app (P<.001); reading the tips, facts, and goals (P<.05); and wearing the Fitbit wearable (P<.001). Few intervention participants found the tips and facts motivating (10/41, 24.4%), used them to be physically active (8/41, 19.6%), and thought they were tailored to their lifestyle (7/41, 17.1%). Conclusions: The lack of significant intervention effects might be due to low continuous user engagement. Advice or feedback that was not perceived as adequately tailored and the difficulty to compete with many popular commercial apps on young people’s smartphones may be responsible for a decrease in the engagement. A stand-alone app does not seem sufficient to promote an active lifestyle among lower educated working young adults; therefore, multicomponent interventions (using both technological and human support), as well as context-specific sensing to provide tailored advice, might be needed in this population. Trial Registration: ClinicalTrials.gov NCT02948803; https://clinicaltrials.gov/ct2/show/results/NCT02948803 (Archived by WebCite at http://www.webcitation.org/71OPFwaoA) %M 30143477 %R 10.2196/10003 %U http://mhealth.jmir.org/2018/8/e10003/ %U https://doi.org/10.2196/10003 %U http://www.ncbi.nlm.nih.gov/pubmed/30143477 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 3 %P e50 %T A Process Evaluation of a Web-Based Mental Health Portal (WalkAlong) Using Google Analytics %A Song,Michael Jae %A Ward,John %A Choi,Fiona %A Nikoo,Mohammadali %A Frank,Anastasia %A Shams,Farhud %A Tabi,Katarina %A Vigo,Daniel %A Krausz,Michael %+ Department of Psychiatry, University of British Columbia, 430-5950 University Boulevard, David Strangway Building, Vancouver, BC, V6T1Z3, Canada, 1 778 899 5205, michaeljaesong@gmail.com %K evaluation %K Google Analytics %K mental health %K website %D 2018 %7 20.08.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: Despite the increasing amount of research on Web-based mental health interventions with proven efficacy, high attrition rates decrease their effectiveness. Continued process evaluations should be performed to maximize the target population’s engagement. Google Analytics has been used to evaluate various health-related Web-based programs and may also be useful for Web-based mental health programs. Objective: The objective of our study was to evaluate WalkAlong.ca, a youth-oriented mental health web-portal, using Google Analytics to inform the improvement strategy for the platform and to demonstrate the use of Google Analytics as a tool for process evaluation of Web-based mental health interventions. Methods: Google Analytics was used to monitor user activity during WalkAlong’s first year of operation (Nov 13, 2013-Nov 13, 2014). Selected Google Analytic variables were overall website engagement including pages visited per session, utilization rate of specific features, and user access mode and location. Results: The results included data from 3076 users viewing 29,299 pages. Users spent less average time on Mindsteps (0 minute 35 seconds) and self-exercises (1 minute 08 seconds), which are important self-help tools, compared with that on the Screener tool (3 minutes 4 seconds). Of all visitors, 82.3% (4378/5318) were desktop users, followed by 12.7 % (677/5318) mobile phone and 5.0% (263/5318) tablet users. Both direct traffic (access via URL) and referrals by email had more than 7 pages viewed per session and longer than average time of 6 minutes per session. The majority of users (67%) accessed the platform from Canada. Conclusions: Engagement and feature utilization rates are higher among people who receive personal invitations to visit the site. Low utilization rates with specific features offer a starting place for further exploration of users in order to identify the root cause. The data provided by Google Analytics, although informative, can be supplemented by other evaluation methods (ie, qualitative methods) in order to better determine the modifications required to improve user engagement. Google Analytics can play a vital role in highlighting the preferences of those using Web-based mental health tools. %M 30126832 %R 10.2196/mental.8594 %U http://mental.jmir.org/2018/3/e50/ %U https://doi.org/10.2196/mental.8594 %U http://www.ncbi.nlm.nih.gov/pubmed/30126832 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 8 %P e245 %T Effect and Process Evaluation of e-Powered Parents, a Web-Based Support Program for Parents of Children With a Chronic Kidney Disease: Feasibility Randomized Controlled Trial %A Geense,Wytske W %A van Gaal,Betsie GI %A Knoll,Jaqueline L %A Maas,Nienke M %A Kok,Gerjo %A Cornelissen,Elisabeth AM %A Nijhuis-van der Sanden,Maria WG %+ IQ Healthcare, Radboud Institute for Health Science, Radboud University Medical Center, PO Box 9101, 6500 HD, Nijmegen,, Netherlands, 31 24 36 66 868, wytske.geense@radboudumc.nl %K child %K chronic kidney failure %K chronic kidney disease %K effect evaluation %K health promotion %K process evaluation %D 2018 %7 01.08.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Parents of children with chronic kidney disease (CKD) experience high levels of stress in the daily management of their child’s illness. Parents need continuously available support and information, yet online support programs are lacking. e-Powered Parents was developed to fill this gap; it is an online program consisting of (1) medical information, (2) an interactive part, and (3) four training modules (stress management, setting limits, communication, and coping). Prior to a large-scale evaluation, we conducted a feasibility study that consisted of an effect study and a process evaluation. Objective: The objectives of our study were to (1) identify the outcome measures that are most likely to capture the potential benefit, (2) evaluate the potential effectiveness and effect size, and (3) evaluate recruitment, reach, the dose received, and context. Methods: We conducted a feasibility study with a two-armed, wait-list randomized controlled trial (RCT). Prior to baseline, parents (n=146) were randomly allocated to group 1 or group 2. After completing the baseline questionnaire, parents in group 1 were given access to e-Powered Parents, while those in group 2 received usual care. At the 6-month follow-up (T1), all parents received a questionnaire and parents in group 2 were given access to e-Powered Parents as well. After 1.5 years, through an extra measurement (T2), we evaluated the effect of long-term exposure. Outcomes were the child’s quality of life (Child Vulnerability Scale), parental stress (Pediatric Inventory for Parents) and fatigue (Multidimensional Fatigue Inventory), self-efficacy in communication with health care professionals (Perceived Efficacy in Patient-Physician Interactions, PEPPI-5), and parental perceptions of family management (Family Management Measure). Floor and ceiling effects and percentage of parents showing no change in scores were calculated. We used linear mixed models to evaluate the potential effectiveness and effect sizes using the intention-to-treat and per-protocol analyses. In the process evaluation, we evaluated recruitment, reach, the dose received, and context using a questionnaire sent to the parents, log-in data, and a focus group interview with health care professionals. Results: At T1 (n=86) and T2 (n=51), no significant effects were found on any of the five outcomes. The PEPPI-5 showed ceiling effects and high percentages of parents showing no change between the measurement times. The information and interactive part of the intervention were used by 84% (57/68) of the parents in group 1 and 49% (32/65) of the parents in group 2. The information pages were visited most often. Overall, 64% (85/133) of the parents logged in to the training platform and 31% (26/85) actually used the training modules. Conclusions: We did not observe any significant effect on any of the outcomes. This could possibly be explained by the minimal use of the intervention and by parents’ heterogeneity. For continued participation, we recommend a tailored intervention and further studies to find out whether and how online programs could be used to support parents in the management of their child’s CKD. Trial Registration: Netherlands Trial Registry NTR4808; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4808 (Archived by WebCite at http://www.webcitation.org/719rCicvW) %M 30068502 %R 10.2196/jmir.9547 %U http://www.jmir.org/2018/8/e245/ %U https://doi.org/10.2196/jmir.9547 %U http://www.ncbi.nlm.nih.gov/pubmed/30068502 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 5 %N 3 %P e23 %T A Text Message–Based Intervention Targeting Alcohol Consumption Among University Students: User Satisfaction and Acceptability Study %A Müssener,Ulrika %A Thomas,Kristin %A Linderoth,Catharina %A Leijon,Matti %A Bendtsen,Marcus %+ Department of Medical and Health Sciences, Linköping University, Linköping, Sweden, S-58183, Sweden, 46 732702426, ulrika.mussener@liu.se %K students %K text messages %K mobile phones %K SMS %K alcohol consumption intervention %D 2018 %7 10.07.2018 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Heavy consumption of alcohol among university students is a global problem, with excessive drinking being the social norm. Students can be a difficult target group to reach, and only a minority seek alcohol-related support. It is important to develop interventions that can reach university students in a way that does not further stretch the resources of the health services. Text messaging (short message service, SMS)–based interventions can enable continuous, real-time, cost-effective, brief support in a real-world setting, but there is a limited amount of evidence for effective interventions on alcohol consumption among young people based on text messaging. To address this, a text messaging–based alcohol consumption intervention, the Amadeus 3 intervention, was developed. Objective: This study explored self-reported changes in drinking habits in an intervention group and a control group. Additionally, user satisfaction among the intervention group and the experience of being allocated to a control group were explored. Methods: Students allocated to the intervention group (n=460) were asked about their drinking habits and offered the opportunity to give their opinion on the structure and content of the intervention. Students in the control group (n=436) were asked about their drinking habits and their experience in being allocated to the control group. Participants received an email containing an electronic link to a short questionnaire. Descriptive analyses of the distribution of the responses to the 12 questions for the intervention group and 5 questions for the control group were performed. Results: The response rate for the user feedback questionnaire of the intervention group was 38% (176/460) and of the control group was 30% (129/436). The variation in the content of the text messages from facts to motivational and practical advice was appreciated by 77% (135/176) participants, and 55% (97/176) found the number of messages per week to be adequate. Overall, 81% (142/176) participants stated that they had read all or nearly all the messages, and 52% (91/176) participants stated that they were drinking less, and increased awareness regarding negative consequences was expressed as the main reason for reduced alcohol consumption. Among the participants in the control group, 40% (52/129) stated that it did not matter that they had to wait for access to the intervention. Regarding actions taken while waiting for access, 48% (62/129) participants claimed that they continued to drink as before, whereas 35% (45/129) tried to reduce their consumption without any support. Conclusions: Although the main randomized controlled trial was not able to detect a statistically significant effect of the intervention, most participants in this qualitative follow-up study stated that participation in the study helped them reflect upon their consumption, leading to altered drinking habits and reduced alcohol consumption. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN95054707; http://www.isrctn.com/ISRCTN95054707 (Archived by WebCite at http://www.webcitation.org/705putNZT) %M 29991469 %R 10.2196/humanfactors.9641 %U http://humanfactors.jmir.org/2018/3/e23/ %U https://doi.org/10.2196/humanfactors.9641 %U http://www.ncbi.nlm.nih.gov/pubmed/29991469 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 5 %P e106 %T Applicability of a Web-Based, Individualized Exercise Intervention in Patients With Liver Disease, Cystic Fibrosis, Esophageal Cancer, and Psychiatric Disorders: Process Evaluation of 4 Ongoing Clinical Trials %A Pfirrmann,Daniel %A Haller,Nils %A Huber,Yvonne %A Jung,Patrick %A Lieb,Klaus %A Gockel,Ines %A Poplawska,Krystyna %A Schattenberg,Jörn Markus %A Simon,Perikles %+ Department of Sports Medicine, Disease Prevention and Rehabilitation, Institute of Sports Science, Johannes Gutenberg University, , Mainz,, Germany, 49 6131 39 23 586, simonpe@uni-mainz.de %K esophageal cancer %K cystic fibrosis %K depression %K nonalcoholic fatty liver disease %K exercise %K eHealth %D 2018 %7 22.05.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: In the primary and secondary prevention of civilization diseases, regular physical activity is recommended in international guidelines to improve disease-related symptoms, delay the progression of the disease, or to enhance postoperative outcomes. In the preoperative context, there has been a paradigm shift in favor of using preconditioning concepts before surgery. Web-based interventions seem an innovative and effective tool for delivering general information, individualized exercise recommendations, and peer support. Objective: Our first objective was to assess feasibility of our Web-based interventional concept and analyze similarities and differences in a sustained exercise implementation in different diseases. The second objective was to investigate the overall participants’ satisfaction with our Web-based concept. Methods: A total of 4 clinical trials are still being carried out, including patients with esophageal carcinoma scheduled for oncologic esophagectomy (internet-based perioperative exercise program, iPEP, study), nonalcoholic fatty liver disease (hepatic inflammation and physical performance in patients with nonalcoholic steatohepatitis, HELP, study), depression (exercise for depression, EXDEP, study), and cystic fibrosis (cystic fibrosis online mentoring for microbiome, exercise, and diet, COMMED, study). During the intervention period, the study population had access to the website with disease-specific content and a disease-specific discussion forum. All participants received weekly, individual tailored exercise recommendations from the sports therapist. The main outcome was the using behavior, which was obtained by investigating the log-in rate and duration. Results: A total of 20 participants (5 from each trial) were analyzed. During the intervention period, a regular contact and a consequent implementation of exercise prescription were easily achieved in all substudies. Across the 4 substudies, there was a significant decrease in log-in rates (P<.001) and log-in durations (P<.001) over time. A detailed view of the different studies shows a significant decrease in log-in rates and log-in durations in the HELP study (P=.004; P=.002) and iPEP study (P=.02; P=.001), whereas the EXDEP study (P=.58; P=.38) and COMMED study (P=.87; P=.56) showed no significant change over the 8-week intervention period. There was no significant change in physical activity within all studies (P=.31). Only in the HELP study, the physical activity level increased steadily over the period analyzed (P=.045). Overall, 17 participants (85%, 17/20) felt secure and were not scared of injury, with no major differences in the subtrials. Conclusions: The universal use of the Web-based intervention appears to be applicable across the heterogonous collectives of our study patients with regard to age and disease. Although the development of physical activity shows only moderate improvements, flexible communication and tailored support could be easily integrated into patients’ daily routine. Trial Registration: iPEP study: ClinicalTrials.gov NCT02478996; https://clinicaltrials.gov/ct2/show/NCT02478996 (Archived by WebCite at http://www.webcitation.org/6zL1UmHaW); HELP study: ClinicalTrials.gov NCT02526732; http://www.webcitation.org/6zJjX7d6K (Archived by WebCite at http://www.webcitation.org/6Nch4ldcL); EXDEP study: ClinicalTrials.gov NCT02874833; https://clinicaltrials.gov/ct2/show/NCT02874833 (Archived by WebCite at http://www.webcitation.org/6zJjj7FuA) %M 29789277 %R 10.2196/resprot.8607 %U http://www.researchprotocols.org/2018/5/e106/ %U https://doi.org/10.2196/resprot.8607 %U http://www.ncbi.nlm.nih.gov/pubmed/29789277 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 5 %P e119 %T The Development of Delta: Using Agile to Develop a Decision Aid for Pediatric Oncology Clinical Trial Enrollment %A Robertson,Eden G %A Wakefield,Claire E %A Cohn,Richard J %A O'Brien,Tracey %A Ziegler,David S %A Fardell,Joanna E %+ Behavioural Sciences Unit, Kids Cancer Centre, Sydney Children's Hospital, Level 1 South, High Street, Randwick, 2031, Australia, 61 0293859868, eden.robertson@unsw.edu.au %K decision support techniques %K decision making %K neoplasms %K patients %K child %K patient portals %D 2018 %7 04.05.2018 %9 Original Paper %J JMIR Res Protoc %G English %X Background: The internet is increasingly being used to disseminate health information. Given the complexity of pediatric oncology clinical trials, we developed Delta, a Web-based decision aid to support families deciding whether or not to enroll their child with cancer in a clinical trial. Objective: This paper details the Agile development process of Delta and user testing results of Delta. Methods: Development was iterative and involved 5 main stages: a requirements analysis, planning, design, development, and user testing. For user testing, we conducted 13 eye-tracking analyses and think-aloud interviews with health care professionals (n=6) and parents (n=7). Results: Results suggested that there was minimal rereading of content and a high level of engagement in content. However, there were some navigational problems. Participants reported high acceptability (12/13) and high usability of the website (8/13). Conclusions: Delta demonstrates the utility for the use of Agile in the development of a Web-based decision aid for health purposes. Our study provides a clear step-by-step guide to develop a Web-based psychosocial tool within the health setting. %M 29728347 %R 10.2196/resprot.9258 %U http://www.researchprotocols.org/2018/5/e119/ %U https://doi.org/10.2196/resprot.9258 %U http://www.ncbi.nlm.nih.gov/pubmed/29728347 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 5 %P e160 %T Web-Based Intervention for Women With Type 1 Diabetes in Pregnancy and Early Motherhood: Critical Analysis of Adherence to Technological Elements and Study Design %A Berg,Marie %A Linden,Karolina %A Adolfsson,Annsofie %A Sparud Lundin,Carina %A Ranerup,Agneta %+ Centre for Person-Centred Care (GPCC), Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Box 457, Gothenburg, 405 30, Sweden, 46 31 7866084, marie.berg@fhs.gu.se %K randomized controlled trial %K eHealth %K mHealth %K case study %D 2018 %7 02.05.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Numerous Web-based interventions have been implemented to promote health and health-related behaviors in persons with chronic conditions. Using randomized controlled trials to evaluate such interventions creates a range of challenges, which in turn can influence the study outcome. Applying a critical perspective when evaluating Web-based health interventions is important. Objective: The objective of this study was to critically analyze and discuss the challenges of conducting a Web-based health intervention as a randomized controlled trial. Method: The MODIAB-Web study was critically examined using an exploratory case study methodology and the framework for analysis offered through the Persuasive Systems Design model. Focus was on technology, study design, and Web-based support usage, with special focus on the forum for peer support. Descriptive statistics and qualitative content analysis were used. Results: The persuasive content and technological elements in the design of the randomized controlled trial included all four categories of the Persuasive Systems Design model, but not all design principles were implemented. The study duration was extended to a period of four and a half years. Of 81 active participants in the intervention group, a maximum of 36 women were simultaneously active. User adherence varied greatly with a median of 91 individual log-ins. The forum for peer support was used by 63 participants. Although only about one-third of the participants interacted in the forum, there was a fairly rich exchange of experiences and advice between them. Thus, adherence in terms of social interactions was negatively affected by limited active participation due to prolonged recruitment process and randomization effects. Lessons learned from this critical analysis are that technology and study design matter and might mutually influence each other. In Web-based interventions, the use of design theories enables utilization of the full potential of technology and promotes adherence. The randomization element in a randomized controlled trial design can become a barrier to achieving a critical mass of user interactions in Web-based interventions, especially when social support is included. For extended study periods, the technology used may need to be adapted in line with newly available technical options to avoid the risk of becoming outdated in the user realm, which in turn might jeopardize study validity in terms of randomized controlled trial designs. Conclusions: On the basis of lessons learned in this randomized controlled trial, we give recommendations to consider when designing and evaluating Web-based health interventions. %M 29720365 %R 10.2196/jmir.9665 %U http://www.jmir.org/2018/5/e160/ %U https://doi.org/10.2196/jmir.9665 %U http://www.ncbi.nlm.nih.gov/pubmed/29720365 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 4 %P e103 %T Utilization of a Clinical Trial Management System for the Whole Clinical Trial Process as an Integrated Database: System Development %A Park,Yu Rang %A Yoon,Young Jo %A Koo,HaYeong %A Yoo,Soyoung %A Choi,Chang-Min %A Beck,Sung-Ho %A Kim,Tae Won %+ Clinical Research Center, Asan Institute of Life Sciences, Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic Of Korea, 1 230103910, twkimmd@amc.seoul.kr %K clinical trial %K information systems %K academic medical center %K information technology %K privacy %D 2018 %7 24.04.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Clinical trials pose potential risks in both communications and management due to the various stakeholders involved when performing clinical trials. The academic medical center has a responsibility and obligation to conduct and manage clinical trials while maintaining a sufficiently high level of quality, therefore it is necessary to build an information technology system to support standardized clinical trial processes and comply with relevant regulations. Objective: The objective of the study was to address the challenges identified while performing clinical trials at an academic medical center, Asan Medical Center (AMC) in Korea, by developing and utilizing a clinical trial management system (CTMS) that complies with standardized processes from multiple departments or units, controlled vocabularies, security, and privacy regulations. Methods: This study describes the methods, considerations, and recommendations for the development and utilization of the CTMS as a consolidated research database in an academic medical center. A task force was formed to define and standardize the clinical trial performance process at the site level. On the basis of the agreed standardized process, the CTMS was designed and developed as an all-in-one system complying with privacy and security regulations. Results: In this study, the processes and standard mapped vocabularies of a clinical trial were established at the academic medical center. On the basis of these processes and vocabularies, a CTMS was built which interfaces with the existing trial systems such as the electronic institutional review board health information system, enterprise resource planning, and the barcode system. To protect patient data, the CTMS implements data governance and access rules, and excludes 21 personal health identifiers according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rule and Korean privacy laws. Since December 2014, the CTMS has been successfully implemented and used by 881 internal and external users for managing 11,645 studies and 146,943 subjects. Conclusions: The CTMS was introduced in the Asan Medical Center to manage the large amounts of data involved with clinical trial operations. Inter- and intraunit control of data and resources can be easily conducted through the CTMS system. To our knowledge, this is the first CTMS developed in-house at an academic medical center side which can enhance the efficiency of clinical trial management in compliance with privacy and security laws. %M 29691212 %R 10.2196/jmir.9312 %U http://www.jmir.org/2018/4/e103/ %U https://doi.org/10.2196/jmir.9312 %U http://www.ncbi.nlm.nih.gov/pubmed/29691212 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 4 %P e10143 %T Trajectories of 12-Month Usage Patterns for Two Smoking Cessation Websites: Exploring How Users Engage Over Time %A Bricker,Jonathan B %A Sridharan,Vasundhara %A Zhu,Yifan %A Mull,Kristin E %A Heffner,Jaimee L %A Watson,Noreen L %A McClure,Jennifer B %A Di,Chongzhi %+ Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA, 98109, United States, 1 2066675074, jbricker@fredhutch.org %K engagement %K trajectories %K eHealth %K websites %K tobacco %K smoking %K acceptance and commitment therapy %K smokefree.gov %K patient participation %K telemedicine %K tobacco use cessation %K smoking cessation %D 2018 %7 20.04.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Little is known about how individuals engage with electronic health (eHealth) interventions over time and whether this engagement predicts health outcomes. Objective: The objectives of this study, by using the example of a specific type of eHealth intervention (ie, websites for smoking cessation), were to determine (1) distinct groups of log-in trajectories over a 12-month period, (2) their association with smoking cessation, and (3) baseline user characteristics that predict trajectory group membership. Methods: We conducted a functional clustering analysis of 365 consecutive days of log-in data from both arms of a large (N=2637) randomized trial of 2 website interventions for smoking cessation (WebQuit and Smokefree), with a primary outcome of 30-day point prevalence smoking abstinence at 12 months. We conducted analyses for each website separately. Results: A total of 3 distinct trajectory groups emerged for each website. For WebQuit, participants were clustered into 3 groups: 1-week users (682/1240, 55.00% of the sample), 5-week users (399/1240, 32.18%), and 52-week users (159/1240, 12.82%). Compared with the 1-week users, the 5- and 52-week users had 57% higher odds (odds ratio [OR] 1.57, 95% CI 1.13-2.17; P=.007) and 124% higher odds (OR 2.24, 95% CI 1.45-3.43; P<.001), respectively, of being abstinent at 12 months. Smokefree users were clustered into 3 groups: 1-week users (645/1309, 49.27% of the sample), 4-week users (395/1309, 30.18%), and 5-week users (269/1309, 20.55%). Compared with the 1-week users, 5-week users (but not 4-week users; P=.99) had 48% higher odds (OR 1.48, 95% CI 1.05-2.07; P=.02) of being abstinent at 12 months. In general, the WebQuit intervention had a greater number of weekly log-ins within each of the 3 trajectory groups as compared with those of the Smokefree intervention. Baseline characteristics associated with trajectory group membership varied between websites. Conclusions: Patterns of 1-, 4-, and 5-week usage of websites may be common for how people engage in eHealth interventions. The 5-week usage of either website, and 52-week usage only of WebQuit, predicted a higher odds of quitting smoking. Strategies to increase eHealth intervention engagement for 4 more weeks (ie, from 1 week to 5 weeks) could be highly cost effective. Trial Registration: ClinicalTrials.gov NCT01812278; https://www.clinicaltrials.gov/ct2/show/NCT01812278 (Archived by WebCite at http://www.webcitation.org/6yPO2OIKR) %M 29678799 %R 10.2196/10143 %U http://www.jmir.org/2018/4/e10143/ %U https://doi.org/10.2196/10143 %U http://www.ncbi.nlm.nih.gov/pubmed/29678799 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 2 %P e22 %T “Wish You Were Here”: Examining Characteristics, Outcomes, and Statistical Solutions for Missing Cases in Web-Based Psychotherapeutic Trials %A Karin,Eyal %A Dear,Blake F %A Heller,Gillian Z %A Crane,Monique F %A Titov,Nickolai %+ eCentreClinic, Department of Psychology, Macquarie University, 4 First Walk, Sydney, 2109, Australia, 61 298508657, eyal.karin@mq.edu.au %K psychotherapy %K treatment adherence and compliance %K missing data %K treatment efficacy %K statistical bias %D 2018 %7 19.04.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: Missing cases following treatment are common in Web-based psychotherapy trials. Without the ability to directly measure and evaluate the outcomes for missing cases, the ability to measure and evaluate the effects of treatment is challenging. Although common, little is known about the characteristics of Web-based psychotherapy participants who present as missing cases, their likely clinical outcomes, or the suitability of different statistical assumptions that can characterize missing cases. Objective: Using a large sample of individuals who underwent Web-based psychotherapy for depressive symptoms (n=820), the aim of this study was to explore the characteristics of cases who present as missing cases at posttreatment (n=138), their likely treatment outcomes, and compare between statistical methods for replacing their missing data. Methods: First, common participant and treatment features were tested through binary logistic regression models, evaluating the ability to predict missing cases. Second, the same variables were screened for their ability to increase or impede the rate symptom change that was observed following treatment. Third, using recontacted cases at 3-month follow-up to proximally represent missing cases outcomes following treatment, various simulated replacement scores were compared and evaluated against observed clinical follow-up scores. Results: Missing cases were dominantly predicted by lower treatment adherence and increased symptoms at pretreatment. Statistical methods that ignored these characteristics can overlook an important clinical phenomenon and consequently produce inaccurate replacement outcomes, with symptoms estimates that can swing from −32% to 70% from the observed outcomes of recontacted cases. In contrast, longitudinal statistical methods that adjusted their estimates for missing cases outcomes by treatment adherence rates and baseline symptoms scores resulted in minimal measurement bias (<8%). Conclusions: Certain variables can characterize and predict missing cases likelihood and jointly predict lesser clinical improvement. Under such circumstances, individuals with potentially worst off treatment outcomes can become concealed, and failure to adjust for this can lead to substantial clinical measurement bias. Together, this preliminary research suggests that missing cases in Web-based psychotherapeutic interventions may not occur as random events and can be systematically predicted. Critically, at the same time, missing cases may experience outcomes that are distinct and important for a complete understanding of the treatment effect. %M 29674311 %R 10.2196/mental.8363 %U http://mental.jmir.org/2018/2/e22/ %U https://doi.org/10.2196/mental.8363 %U http://www.ncbi.nlm.nih.gov/pubmed/29674311 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 1 %P e1 %T A Perioperative eHealth Program to Enhance Postoperative Recovery After Abdominal Surgery: Process Evaluation of a Randomized Controlled Trial %A van der Meij,Eva %A Huirne,Judith AF %A ten Cate,A Dorien %A Stockmann,Hein BAC %A Scholten,Piet C %A Davids,Paul HP %A Bonjer,H Jaap %A Anema,Johannes R %+ Amsterdam Public Health Research Institute, Department of Public and Occupational Health, VU University Medical Center, van der Boechorststraat 7, 1081 BT, Amsterdam,, Netherlands, 31 204450703, ev.vandermeij@vumc.nl %K telemedicine %K cholecystectomy %K surgical procedures, operative %K perioperative care %K convalescence %K process assessment %D 2018 %7 02.01.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Electronic health (eHealth) interventions have proven effective, but implementation in clinical practice is difficult. More research focusing on the implementation process of eHealth interventions is necessary. Objective: The objective of this study was to describe the process evaluation of a perioperative eHealth intervention, aiming to enhance recovery after laparoscopic abdominal surgery. Methods: A process evaluation was carried out alongside a multicenter randomized controlled trial. Patients aged between 18 and 75 years who were scheduled for a laparoscopic cholecystectomy, hernia inguinal surgery, or laparoscopic adnexal surgery were included. The eHealth intervention comprised a website and mobile phone app with the possibility to develop a personalized convalescence plan, a section with information about the surgical procedure and the recovery period, the possibility to ask questions via an electronic consultation (eConsult), and an activity tracker. The process evaluation was carried out using the model of Linnan and Steckler, measuring components such as reach, dose delivered, dose received, fidelity, and participants’ attitudes. Implementation scores were calculated based on the average of the four components. Quantitative data were collected by means of an electronic questionnaire, a logistic database, a weblog, and medical files. Qualitative data were collected by conducting interviews with a subsample of the study participants. Results: A total of 344 of the 863 eligible patients were included in the study, which accounted for a reach of 39.9%, and 173 participants were randomized to the intervention group. The implementation scores of the different functions of the intervention ranged between 60% and 65%. The website, mobile phone app, and activity tracker were rated 7.3 to 7.6 on a scale of 1 to 10. Almost all participants who were interviewed about the eConsult function rated it as being of additional value if combined with the usual care but not as a replacement for usual care. Conclusions: Although participants were overall satisfied with the intervention, the implementation scores of the different functions of the intervention were fair. More research is needed to evaluate the barriers and facilitators for implementation of this perioperative eHealth intervention in normal practice outside study setting. Trial Registration: Netherlands Trial Registry NTR4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6vr02V4KK) %M 29295808 %R 10.2196/jmir.8338 %U http://www.jmir.org/2018/1/e1/ %U https://doi.org/10.2196/jmir.8338 %U http://www.ncbi.nlm.nih.gov/pubmed/29295808 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 12 %P e423 %T Implementation of the Blended Care Self-Management Program for Caregivers of People With Early-Stage Dementia (Partner in Balance): Process Evaluation of a Randomized Controlled Trial %A Boots,Lizzy MM %A de Vugt,Marjolein E %A Smeets,Claudia MJ %A Kempen,Gertrudis IJM %A Verhey,Frans RJ %+ Department of Psychiatry and Neuropsychology, Alzheimer Center Limburg, School for Mental Health and Neurosciences, Maastricht University Medical Center+, Faculty of Health, Medicine and Life Sciences, PO Box 616, Maastricht, 6200 MD, Netherlands, 31 43 3881994, l.boots@maastrichtuniversity.nl %K internet %K caregivers %K technology %K therapeutics %D 2017 %7 19.12.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Caring for a family member with dementia puts caregivers at risk of overburdening. Electronic health (eHealth) support for caregivers offers an opportunity for accessible tailored interventions. The blended care self-management program “Partner in Balance” (PiB) for early-stage dementia caregivers was executed in Dutch dementia care organizations. The program combines face-to-face coaching with tailored Web-based modules. Next to an evaluation of program effectiveness, an evaluation of sampling and intervention quality is essential for the generalizability and interpretation of results. Objective: The aim of this study was to describe the process evaluation from the perspective of both family caregivers (participants) and professionals delivering the intervention (coaches) to determine internal and external validity before the effect analysis and aid future implementation. Methods: Implementation, sampling, and intervention quality were evaluated with quantitative and qualitative data from logistical research data, coach questionnaires (n=13), and interviews with coaches (n=10) and participants (n=49). Goal attainment scaling was used to measure treatment-induced change. Analyses were performed with descriptive statistics and deductive content analysis. Results: The participation rate of eligible caregivers was 51.9% (80/154). Recruitment barriers were lack of computer and lack of need for support. Young age and employment were considered recruitment facilitators. All coaches attended training and supervision in blended care self-management. Deviations from the structured protocol were reported on intervention time, structure, and feedback. Coaches described an intensified relationship with the caregiver post intervention. Caregivers appreciated the tailored content and positive feedback. The blended structure increased their openness. The discussion forum was appreciated less. Overall, personal goals were attained after the program (T>50). Implementation barriers included lack of financing, time, and deviating target population. Conclusions: Participants and coaches were satisfied with the intervention, but adapting the content to specific subgroups, for example, younger caregivers, was recommended. Implementation of the program requires more awareness of the benefits of blended care self-management programs and training in tailored self-management skills. Trial Registration: Dutch Trial Register (NTR): NTR4748; http://www.trialregister.nl (Archived by WebCite at http://www.webcitation.org/6vSb2t9Mg) %M 29258980 %R 10.2196/jmir.7666 %U http://www.jmir.org/2017/12/e423/ %U https://doi.org/10.2196/jmir.7666 %U http://www.ncbi.nlm.nih.gov/pubmed/29258980 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 4 %N 4 %P e24 %T Lack of Adoption of a Mobile App to Support Patient Self-Management of Diabetes and Hypertension in a Federally Qualified Health Center: Interview Analysis of Staff and Patients in a Failed Randomized Trial %A Thies,Kathleen %A Anderson,Daren %A Cramer,Benjamin %+ Community Health Center, Inc., Weitzman Institute, 631 Main St, Middletown, CT, 06457, United States, 1 603 661 9113, thiesk@chc1.com %K telehealth %K mobile health %K mHealth %K underserved patients %K HIT %K usability %D 2017 %7 03.10.2017 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Thousands of mobile health (mHealth) apps have been developed to support patients’ management of their health, but the effectiveness of many of the apps remains unclear. While mHealth apps appear to hold promise for improving the self-management of chronic conditions across populations, failure to balance the system demands of the app with the needs, interests, or resources of the end users can undermine consumers’ adoption of these technologies. Objective: The original aim of this study was to evaluate the effectiveness of a commercial mHealth app in improving clinical outcomes for adult patients in a Federally Qualified Health Center (FQHC) with uncontrolled diabetes and/or hypertension. Patients entered clinical data into the app, which also supported messaging between patients and providers. After a 4-month period of vigorous recruitment, the trial was suspended due to low enrollment and inconsistent use of the app by enrolled patients. The project aim was changed to understanding why the trial was unsuccessful. Methods: We used the user-task-context (eUTC) usability framework to develop a set of interview questions for patients and staff who were involved in the trial. All interviews were done by phone and lasted 20 to 30 minutes. Interviews were not recorded. Results: There was a poor fit between the app, end users, and recruitment and treatment approaches in our setting. Usability testing might have revealed this prior to launch but was not an option. There was not sufficient time during routine care for clinical staff to familiarize patients with the app or to check clinical data and messages, which are unreimbursed activities. Some patients did not use the app appropriately. The lack of integration with the electronic health record (EHR) was cited as a problem for both patients and staff who also said the app was just one more thing to attend to. Conclusions: This brief trial underscores the pitfalls in the utilization of mHealth apps. Effective use of mHealth tools requires a good fit between the app, the users’ electronic health (eHealth) literacy, the treatment approach, staff time, and reimbursement for services. The last 3 are contextual factors of the setting that affected the adoption of the app and context is an important factor in implementation science. We recommend that researchers address contextual factors in the trial and adoption of mHealth technologies. %M 28974481 %R 10.2196/humanfactors.7709 %U https://humanfactors.jmir.org/2017/4/e24/ %U https://doi.org/10.2196/humanfactors.7709 %U http://www.ncbi.nlm.nih.gov/pubmed/28974481 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 1 %N 1 %P e1 %T The Impact of Participant Characteristics on Use and Satisfaction of a Web-Based Computer-Tailored Chronic Obstructive Pulmonary Disease Self-Management Intervention: A Process Evaluation %A Voncken-Brewster,Viola %A Amoureus,Mylène %A de Vries,Hein %A Nagykaldi,Zsolt %A Winkens,Bjorn %A van der Weijden,Trudy %A Tange,Huibert %+ Department of Family Medicine, Care and Public Health Research Institute, Maastricht University Medical Center, Maastricht University, PO Box 616, Maastricht,, Netherlands, 31 43 388 2230, viola.voncken@maastrichtuniversity.nl %K Internet intervention %K computer tailoring %K application use %K participant characteristics %K COPD %K self-management %K behavior change %K process evaluation %D 2017 %7 21.08.2017 %9 Original Paper %J JMIR Formativ Res %G English %X Background: A randomized controlled trial (RCT) showed that a Web-based computer-tailored self-management intervention for people with or at risk for chronic obstructive pulmonary disease (COPD) did not have a significant treatment effect. Process evaluation measures such as application use and satisfaction with the intervention can help understand these results. Objectives: The aim of this paper is to uncover reasons for suboptimal application use, evaluate satisfaction with the intervention, and investigate which participant characteristics predict application use and user satisfaction. Methods: Participants were recruited through 2 different channels: an online panel and general practice. The intervention group received the intervention, which consisted of 2 modules (smoking cessation and physical activity). The control group received no intervention. The study employed a mixed methods design. Quantitative and qualitative data were gathered assessing participant characteristics, application use, reasons for not using the application, and satisfaction with the intervention. Results: The RCT included 1325 participants. The proportion of individuals who participated was significantly higher in the online group (4072/6844, 59.5%) compared to the general practice group (43/335, 12.8%) (P<.001). Application use was low. Of all participants in the intervention group, 52.9% (348/658) initiated use of one or both modules, 36.0% (237/658) completed an intervention component (prolonged use), and 16.6% (109/658) revisited one of the modules after completing an intervention component (sustained use). Older age, established diagnosis of COPD, or experiencing breathlessness predicted sustained use. Participant satisfaction with the 2 modules was 6.7 (SD 1.6) on a scale from 0 to 10. The interviews revealed that a computer application was believed not to be sufficient and the help of a health care professional was necessary. Participants with a greater intention to change were more satisfied with the application. Conclusions: The application was not used sufficiently. Study materials should be further tailored to younger individuals, those at risk for COPD, and those who do not experience breathlessness in order to increase sustained use among them. Involvement of a health care professional could improve satisfaction with the intervention and potentially increase engagement with the intervention materials. However, to make this possible, recruitment in general practice needs to be improved. Recommendations are made for improving the study design, strengthening the intervention (eg, practice facilitation), and linking the computer application to interaction with a health care provider. %M 30684399 %R 10.2196//formative.6585 %U https://formative.jmir.org/2017/1/e1/ %U https://doi.org/10.2196//formative.6585 %U http://www.ncbi.nlm.nih.gov/pubmed/30684399 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 6 %P e89 %T Assessing User Engagement of an mHealth Intervention: Development and Implementation of the Growing Healthy App Engagement Index %A Taki,Sarah %A Lymer,Sharyn %A Russell,Catherine Georgina %A Campbell,Karen %A Laws,Rachel %A Ong,Kok-Leong %A Elliott,Rosalind %A Denney-Wilson,Elizabeth %+ University of Technology Sydney, Bldg 10, 8th Fl, 235 Jones St, Ultimo NSW, Sydney, 2007, Australia, 61 0424393630, sarah.b.taki@student.uts.edu.au %K mHealth %K social medium %K infant obesity %K infant development %K children %K infants %K practitioners %K primary healthcare %D 2017 %7 29.06.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Childhood obesity is an ongoing problem in developed countries that needs targeted prevention in the youngest age groups. Children in socioeconomically disadvantaged families are most at risk. Mobile health (mHealth) interventions offer a potential route to target these families because of its relatively low cost and high reach. The Growing healthy program was developed to provide evidence-based information on infant feeding from birth to 9 months via app or website. Understanding user engagement with these media is vital to developing successful interventions. Engagement is a complex, multifactorial concept that needs to move beyond simple metrics. Objective: The aim of our study was to describe the development of an engagement index (EI) to monitor participant interaction with the Growing healthy app. The index included a number of subindices and cut-points to categorize engagement. Methods: The Growing program was a feasibility study in which 300 mother-infant dyads were provided with an app which included 3 push notifications that was sent each week. Growing healthy participants completed surveys at 3 time points: baseline (T1) (infant age ≤3 months), infant aged 6 months (T2), and infant aged 9 months (T3). In addition, app usage data were captured from the app. The EI was adapted from the Web Analytics Demystified visitor EI. Our EI included 5 subindices: (1) click depth, (2) loyalty, (3) interaction, (4) recency, and (5) feedback. The overall EI summarized the subindices from date of registration through to 39 weeks (9 months) from the infant’s date of birth. Basic descriptive data analysis was performed on the metrics and components of the EI as well as the final EI score. Group comparisons used t tests, analysis of variance (ANOVA), Mann-Whitney, Kruskal-Wallis, and Spearman correlation tests as appropriate. Consideration of independent variables associated with the EI score were modeled using linear regression models. Results: The overall EI mean score was 30.0% (SD 11.5%) with a range of 1.8% - 57.6%. The cut-points used for high engagement were scores greater than 37.1% and for poor engagement were scores less than 21.1%. Significant explanatory variables of the EI score included: parity (P=.005), system type including “app only” users or “both” app and email users (P<.001), recruitment method (P=.02), and baby age at recruitment (P=.005). Conclusions: The EI provided a comprehensive understanding of participant behavior with the app over the 9-month period of the Growing healthy program. The use of the EI in this study demonstrates that rich and useful data can be collected and used to inform assessments of the strengths and weaknesses of the app and in turn inform future interventions. %M 28663164 %R 10.2196/mhealth.7236 %U http://mhealth.jmir.org/2017/6/e89/ %U https://doi.org/10.2196/mhealth.7236 %U http://www.ncbi.nlm.nih.gov/pubmed/28663164 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 5 %N 4 %P e47 %T A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings %A Maar,Marion A %A Yeates,Karen %A Perkins,Nancy %A Boesch,Lisa %A Hua-Stewart,Diane %A Liu,Peter %A Sleeth,Jessica %A Tobe,Sheldon W %+ Faculty of Medicine, Northern Ontario School of Medicine, Laurentian University, 935 Ramsey Lake Rd, Sudbury, ON, P3E 2C6, Canada, 1 705 662 7233, mmaar@nosm.ca %K mobile health %K health care texting %K SMS %K protocol %K process evaluation %K process assessment (health care) %K health services, Indigenous %K Tanzania %K community-based participatory research %K DREAM-GLOBAL %D 2017 %7 20.04.2017 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: To facilitate decision-making capacity between options of care under real-life service conditions, clinical trials must be pragmatic to evaluate mobile health (mHealth) interventions under the variable conditions of health care settings with a wide range of participants. The mHealth interventions require changes in the behavior of patients and providers, creating considerable complexity and ambiguity related to causal chains. Process evaluations of the implementation are necessary to shed light on the range of unanticipated effects an intervention may have, what the active ingredients in everyday practice are, how they exert their effect, and how these may vary among recipients or between sites. Objective: Building on the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) statement and participatory evaluation theory, we present a framework for the process evaluations for mHealth interventions in multiple cultural settings. We also describe the application of this evaluation framework to the implementation of DREAM-GLOBAL (Diagnosing hypertension—Engaging Action and Management in Getting Lower BP in Indigenous and LMIC [low- and middle-income countries]), a pragmatic randomized controlled trial (RCT), and mHealth intervention designed to improve hypertension management in low-resource environments. We describe the evaluation questions and the data collection processes developed by us. Methods: Our literature review revealed that there is a significant knowledge gap related to the development of a process evaluation framework for mHealth interventions. We used community-based participatory research (CBPR) methods and formative research data to develop a process evaluation framework nested within a pragmatic RCT. Results: Four human organizational levels of participants impacted by the mHealth intervention were identified that included patients, providers, community and organizations actors, and health systems and settings. These four levels represent evaluation domains and became the core focus of the evaluation. In addition, primary implementation themes to explore in each of the domains were identified as follows: (1) the major active components of the intervention, (2) technology of the intervention, (3) cultural congruence, (4) task shifting, and (5) unintended consequences. Using the four organizational domains and their interaction with primary implementation themes, we developed detailed evaluation research questions and identified the data or information sources to best answer our questions. Conclusions: Using DREAM-GLOBAL to illustrate our approach, we succeeded in developing an uncomplicated process evaluation framework for mHealth interventions that provide key information to stakeholders, which can optimize implementation of a pragmatic trial as well as inform scale up. The human organizational level domains used to focus the primary implementation themes in the DREAM-GLOBAL process evaluation framework are sufficiently supported in our research, and the literature and can serve as a valuable tool for other mHealth process evaluations. Trial Registration: ClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226 (Archived by WebCite at http://www.webcitation.org/6oxfHXege) %M 28428165 %R 10.2196/mhealth.7044 %U http://mhealth.jmir.org/2017/4/e47/ %U https://doi.org/10.2196/mhealth.7044 %U http://www.ncbi.nlm.nih.gov/pubmed/28428165 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 1 %P e6 %T Does Usage of an eHealth Intervention Reduce the Risk of Excessive Gestational Weight Gain? Secondary Analysis From a Randomized Controlled Trial %A Graham,Meredith Leigh %A Strawderman,Myla S %A Demment,Margaret %A Olson,Christine Marie %+ Division of Nutritional Sciences, Cornell University, Savage Hall, 4th floor, Ithaca, NY, 14853, United States, 1 585 298 5660, mlg22@cornell.edu %K Internet %K obesity %K weight gain %K pregnancy %D 2017 %7 09.01.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Excessive gestational weight gain (GWG) contributes to the development of obesity in mother and child. Internet-based interventions have the potential for delivering innovative and interactive options for prevention of excessive GWG to large numbers of people. Objective: The objective of this study was to create a novel measure of Internet-based intervention usage patterns and examine whether usage of an Internet-based intervention is associated with reduced risk of excessive GWG. Methods: The website featured blogs, local resources, articles, frequently asked questions (FAQs), and events that were available to women in both the intervention and control arm. Weekly reminders to use the website and to highlight new content were emailed to participants in both arms. Only intervention arm participants had access to the weight gain tracker and diet and physical activity goal-setting tools. A total of 1335 (898 intervention and 437 control) relatively diverse and healthy pregnant women were randomly assigned to the intervention arm or control arm. Usage patterns were examined for both intervention and control arm participants using latent class analysis. Regression analyses were used to estimate the association between usage patterns and three GWG outcomes: excessive total GWG, excessive GWG rate, and GWG. Results: Five usage patterns best characterized the usage of the intervention by intervention arm participants. Three usage patterns best characterized control arm participants’ usage. Control arm usage patterns were not associated with excessive GWG, whereas intervention arm usage patterns were associated with excessive GWG. Conclusions: The control and intervention arm usage pattern characterization is a unique methodological contribution to process evaluations for self-directed Internet-based interventions. In the intervention arm some usage patterns were associated with GWG outcomes. ClinicalTrial: ClinicalTrials.gov; Clinical Trials Number: NCT01331564; https://clinicaltrials.gov/ct2/show/NCT01331564 (Archived by WebCite at http://www.webcitation/6nI9LuX9w) %M 28069560 %R 10.2196/jmir.6644 %U http://www.jmir.org/2017/1/e6/ %U https://doi.org/10.2196/jmir.6644 %U http://www.ncbi.nlm.nih.gov/pubmed/28069560 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 12 %P e316 %T An eHealth Project on Invasive Pneumococcal Disease: Comprehensive Evaluation of a Promotional Campaign %A Panatto,Donatella %A Domnich,Alexander %A Gasparini,Roberto %A Bonanni,Paolo %A Icardi,Giancarlo %A Amicizia,Daniela %A Arata,Lucia %A Carozzo,Stefano %A Signori,Alessio %A Bechini,Angela %A Boccalini,Sara %+ Department of Health Sciences, University of Genoa, Via Pastore, 1, Genoa, 16132, Italy, 39 0103538109, panatto@unige.it %K invasive pneumococcal disease %K pneumococcus %K eHealth %K mHealth %K mobile app %D 2016 %7 02.12.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: The recently launched Pneumo Rischio eHealth project, which consists of an app, a website, and social networking activity, is aimed at increasing public awareness of invasive pneumococcal disease (IPD). The launch of this project was prompted by the inadequate awareness of IPD among both laypeople and health care workers, the heavy socioeconomic burden of IPD, and the far from optimal vaccination coverage in Italy, despite the availability of safe and effective vaccines. Objective: The objectives of our study were to analyze trends in Pneumo Rischio usage before and after a promotional campaign, to characterize its end users, and to assess its user-rated quality. Methods: At 7 months after launching Pneumo Rischio, we established a 4-month marketing campaign to promote the project. This intervention used various approaches and channels, including both traditional and digital marketing strategies. To highlight usage trends, we used different techniques of time series analysis and modeling, including a modified Mann-Kendall test, change-point detection, and segmented negative binomial regression of interrupted time series. Users were characterized in terms of demographics and IPD risk categories. Customer-rated quality was evaluated by means of a standardized tool in a sample of app users. Results: Over 1 year, the app was accessed by 9295 users and the website was accessed by 143,993 users, while the project’s Facebook page had 1216 fans. The promotional intervention was highly effective in increasing the daily number of users. In particular, the Mann-Kendall trend test revealed a significant (P ≤.01) increasing trend in both app and website users, while change-point detection analysis showed that the first significant change corresponded to the start of the promotional campaign. Regression analysis showed a significant immediate effect of the intervention, with a mean increase in daily numbers of users of 1562% (95% CI 456%-4870%) for the app and 620% (95% CI 176%-1777%) for the website. Similarly, the postintervention daily trend in the number of users was positive, with a relative increase of 0.9% (95% CI 0.0%-1.8%) for the app and 1.4% (95% CI 0.7%-2.1%) for the website. Demographics differed between app and website users and Facebook fans. A total of 69.15% (10,793/15,608) of users could be defined as being at risk of IPD, while 4729 users expressed intentions to ask their doctor for further information on IPD. The mean app quality score assigned by end users was approximately 79.5% (397/500). Conclusions: Despite its specific topic, Pneumo Rischio was accessed by a considerable number of users, who ranked it as a high-quality project. In order to reach their target populations, however, such projects should be promoted. %M 27913372 %R 10.2196/jmir.6205 %U http://www.jmir.org/2016/12/e316/ %U https://doi.org/10.2196/jmir.6205 %U http://www.ncbi.nlm.nih.gov/pubmed/27913372 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 4 %P e216 %T A Comparison of Mobile and Fixed Device Access on User Engagement Associated With Women, Infants, and Children (WIC) Online Nutrition Education %A Brusk,John J %A Bensley,Robert J %+ Western Michigan University, Department of Human Performance and Health Education, 1903 W. Michigan Ave., Kalamazoo, MI, 49008, United States, 1 269 387 3081, bensley@wmich.edu %K Internet %K mobile phone %K mHealth %K eHealth %D 2016 %7 15.11.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Online health education has expanded its reach due to cost-effective implementation and demonstrated effectiveness. However, a limitation exists with the evaluation of online health education implementations and how the impact of the system is attenuated by the extent to which a user engages with it. Moreover, the current online health education research does not consider how this engagement has been affected by the transition from fixed to mobile user access over the last decade. Objective: This paper focuses on comparing the impact mobile versus fixed devices have on user engagement key performance indicators (KPI) associated with the wichealth website (.org), an Internet-based parent-child feeding intervention offered to clients associated with the US Department of Agriculture’s Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Methods: Data were collected from 612,201 nutrition education lessons completed by 305,735 unique WIC participants in 21 states over a 1-year period. Data consisted of system-collected measures, profile items, and items from an exit survey administered at the conclusion of each lesson. User engagement was defined based on 3 KPIs associated with usage of the wichealth website: number of link views, link view time, and progression in stage of readiness to change. Independent samples t tests were used to compare KPIs between fixed only and mobile only device users and paired samples t tests were used to compare KPIs within users who completed at least one lesson each on both a fixed and mobile device. A logistic regression was performed to estimate the odds of KPI performance thresholds in the independent samples study group given access device type while controlling for confounding of user characteristics associated with these KPIs. Results: Analysis of 8 user characteristics (lessons completed, race, ethnicity, language, state of residence, pregnancy status, beginning stage of change, and preferred nutrition education method) were significantly (P<.001) related to various KPI differences between mobile and fixed device access. Non-mobile users were significantly (P<.001) more likely to engage based on all 3 KPIs, even after logistic regression control for the potential confounding related to the strongly associated user characteristics identified. Conclusions: The findings of this study support the idea that online health education developers need to seriously consider access device when creating programs. Online health education developers need to take extra effort to truly understand access patterns of populations being served, and whether or not access device will influence user engagement performance indicators. %M 27847351 %R 10.2196/resprot.6608 %U http://www.researchprotocols.org/2016/4/e216/ %U https://doi.org/10.2196/resprot.6608 %U http://www.ncbi.nlm.nih.gov/pubmed/27847351 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 8 %P e229 %T Use and Appreciation of a Tailored Self-Management eHealth Intervention for Early Cancer Survivors: Process Evaluation of a Randomized Controlled Trial %A Kanera,Iris Maria %A Willems,Roy A %A Bolman,Catherine A W %A Mesters,Ilse %A Zambon,Victor %A Gijsen,Brigitte CM %A Lechner,Lilian %+ Faculty of Psychology and Educational Sciences, Open University of the Netherlands, Valkenburgerweg 177, Heerlen, 6401 DL, Netherlands, 31 455762448, iris.kanera@ou.nl %K eHealth %K web-based intervention %K computer tailoring %K cancer survivorship %K intervention usage %K appreciation %K multiple behavior intervention %K process evaluation %K self-management %D 2016 %7 23.08.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: A fully automated computer-tailored Web-based self-management intervention, Kanker Nazorg Wijzer (KNW [Cancer Aftercare Guide]), was developed to support early cancer survivors to adequately cope with psychosocial complaints and to promote a healthy lifestyle. The KNW self-management training modules target the following topics: return to work, fatigue, anxiety and depression, relationships, physical activity, diet, and smoking cessation. Participants were guided to relevant modules by personalized module referral advice that was based on participants’ current complaints and identified needs. Objective: The aim of this study was to evaluate the adherence to the module referral advice, examine the KNW module use and its predictors, and describe the appreciation of the KNW and its predictors. Additionally, we explored predictors of personal relevance. Methods: This process evaluation was conducted as part of a randomized controlled trial. Early cancer survivors with various types of cancer were recruited from 21 Dutch hospitals. Data from online self-report questionnaires and logging data were analyzed from participants allocated to the intervention condition. Chi-square tests were applied to assess the adherence to the module referral advice, negative binominal regression analysis was used to identify predictors of module use, multiple linear regression analysis was applied to identify predictors of the appreciation, and ordered logistic regression analysis was conducted to explore possible predictors of perceived personal relevance. Results: From the respondents (N=231; mean age 55.6, SD 11.5; 79.2% female [183/231]), 98.3% (227/231) were referred to one or more KNW modules (mean 2.9, SD 1.5), and 85.7% (198/231) of participants visited at least one module (mean 2.1, SD 1.6). Significant positive associations were found between the referral to specific modules (range 1-7) and the use of corresponding modules. The likelihoods of visiting modules were higher when respondents were referred to those modules by the module referral advice. Predictors of visiting a higher number of modules were a higher number of referrals by the module referral advice (β=.136, P=.009), and having a partner was significantly related with a lower number of modules used (β=-.256, P=.044). Overall appreciation was high (mean 7.5, SD 1.2; scale 1-10) and was significantly predicted by a higher perceived personal relevance (β=.623, P=.000). None of the demographic and cancer-related characteristics significantly predicted the perceived personal relevance. Conclusions: The KNW in general and more specifically the KNW modules were well used and highly appreciated by early cancer survivors. Indications were found that the module referral advice might be a meaningful intervention component to guide the users in following a preferred selection of modules. These results indicate that the fully automated Web-based KNW provides personal relevant and valuable information and support for early cancer survivors. Therefore, this intervention can complement usual cancer aftercare and may serve as a first step in a stepped-care approach. Trial Registration: Nederlands Trial Register: NTR3375; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3375 (Archived by WebCite at http://www.webcitation.org/6jo4jO7kb) %M 27554525 %R 10.2196/jmir.5975 %U http://www.jmir.org/2016/8/e229/ %U https://doi.org/10.2196/jmir.5975 %U http://www.ncbi.nlm.nih.gov/pubmed/27554525 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e142 %T Young Adult Utilization of a Smoking Cessation Website: An Observational Study Comparing Young and Older Adult Patterns of Use %A Cantrell,Jennifer %A Ilakkuvan,Vinu %A Graham,Amanda L %A Richardson,Amanda %A Xiao,Haijun %A Mermelstein,Robin J %A Curry,Susan J %A Sporer,Amy K %A Vallone,Donna M %+ Evaluation Science and Research, Truth Initiative, 900 G Street, Fourth Floor, Washington, DC,, United States, 1 202 454 5798, jcantrell@truthinitiative.org %K young adults, smoking cessation, Internet, utilization %D 2016 %7 11.07.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: There is little research on how young adults or young adult subgroups utilize and engage with Web-based cessation interventions when trying to quit smoking. Addressing this knowledge gap is important to identify opportunities to optimize the effectiveness of online cessation programs across diverse young adult users. Objective: This study examines utilization of the BecomeAnEX.org smoking cessation website among young adults and young adult subgroups compared with older adults to identify patterns of use by age, gender, and race/ethnicity. Methods: Study participants were 5983 new registered users on a free smoking cessation website who were aged 18 to 70 years. Website utilization was tracked for 6 months; metrics of use included website visits, pages per visit, length of visit, and interaction with specific website features. Differences in website use by age were examined via bivariate analyses and multivariate logistic regression adjusted for age, gender, and race/ethnicity. Interactions were examined to determine differences by gender and race/ethnicity within young (18- to 24-year-olds and 25- to 34-year-olds) and older (35 years and older) adult segments. Results: A greater percentage of young adults aged 18 to 34 years visited the site only once compared with older adults aged 35 years and older (72.05% vs 56.59%, respectively; P<.001). Young adults also spent less time on the site and viewed fewer pages than older adults. In adjusted analyses, young adults were significantly less likely than older adults to visit the site more than once (18-24 years: adjusted odds ratio [AOR] 0.58, 95% CI 0.49-0.68, P<.001; 25-34 years: AOR 0.56, 95% CI 0.50-0.64, P<.001), spend more than 3 minutes on the site (18-24 years: AOR 0.67, 95% CI 0.57-0.79, P<.001; 25-34 years: AOR 0.56, 95% CI 0.49-0.64, P<.001), view 12 or more pages (18-24 years: AOR 0.72, 95% CI 0.61-0.83; P<.001; 25-34 years: AOR 0.67, 95% CI 0.59-0.76, P<.001), utilize the BecomeAnEX.org community (18-24 years: AOR 0.61, 95% CI 0.48-0.79, P<.001; 25-34 years: AOR 0.73, 95% CI 0.60-0.88, P<.001), or utilize Separation Exercises (18-24 years: AOR 0.68, 95% CI 0.51-0.89, P<.01; 25-34 years: AOR 0.77, 95% CI 0.63-0.94, P<.01). Gender differences in utilization were more pronounced among young adults compared with older adults, with lower levels of utilization among young men than young women. For all age groups, utilization was higher among whites and African Americans than among Hispanics and other racial minorities, with one exception—BecomeAnEX.org community utilization was significantly higher among Hispanic young adults compared with white and African American young adults. Conclusions: Results point to important areas of inquiry for future research and development efforts. Research should focus on enhancing demand and increasing engagement among younger adults and men, examining strategies for capitalizing on young adult developmental needs, and increasing utilization of effective site features among diverse young adult users. %M 27401019 %R 10.2196/resprot.4881 %U http://www.researchprotocols.org/2016/3/e142/ %U https://doi.org/10.2196/resprot.4881 %U http://www.ncbi.nlm.nih.gov/pubmed/27401019 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e134 %T The SmokefreeTXT (SFTXT) Study: Web and Mobile Data Collection to Evaluate Smoking Cessation for Young Adults %A Squiers,Linda %A Brown,Derick %A Parvanta,Sarah %A Dolina,Suzanne %A Kelly,Bridget %A Dever,Jill %A Southwell,Brian G %A Sanders,Amy %A Augustson,Erik %+ RTI International, Center for Communication Science, 6110 Executive Boulevard, Suite 902, Rockville, MD, 20852-3907, United States, 1 919 597 5128, lsquiers@rti.org %K tobacco use cessation %K text messaging %K clinical trial %K survey methods %K cell phones %K telemedicine %D 2016 %7 27.06.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Text messaging (short message service, SMS) has been shown to be effective in delivering interventions for various diseases and health conditions, including smoking cessation. While there are many published studies regarding smoking cessation text messaging interventions, most do not provide details about the study’s operational methods. As a result, there is a gap in our understanding of how best to design studies of smoking cessation text messaging programs. Objective: The purpose of this paper is to detail the operational methods used to conduct a randomized trial comparing three different versions of the National Cancer Institute’s SmokefreeText (SFTXT) program, designed for smokers 18 to 29 years of age. We detail our methods for recruiting participants from the Internet, reducing fraud, conducting online data collection, and retaining panel study participants. Methods: Participants were recruited through website advertisements and market research online panels. Screening questions established eligibility for the study (eg, 18 to 29 years of age, current smoker). Antifraud measures screened out participants who could not meet the study requirements. After completing a baseline survey, participants were randomized to one of three study arms, which varied by type and timing of text message delivery. The study offered US $20 gift cards as incentives to complete each of four follow-up surveys. Automated email reminders were sent at designated intervals to increase response rates. Researchers also provided telephone reminders to those who had not completed the survey after multiple email reminders. We calculated participation rates across study arms and compared the final sample characteristics to the Current Population Survey to examine generalizability. Results: Recruitment methods drove 153,936 unique visitors to the SFTXT Study landing page and 27,360 began the screener. Based on the screening questions, 15,462 out of 27,360 responders (56.51%) were eligible to participate. Of the 15,462 who were eligible, 9486 passed the antifraud measures that were implemented; however, 3882 failed to verify their email addresses or cell phone numbers, leaving 5604 who were invited to complete the baseline survey. Of the 5604 who were invited, 4432 completed the baseline survey, but only 4027 were retained for analysis because 405 did not receive the intervention. Conclusions: Although antifraud measures helped to catch participants who failed study requirements and could have biased the data collected, it is possible that the email and cell phone verification check excluded some potentially eligible participants from the study. Future research should explore ways to implement verification methods without risking the loss of so many potential participants. ClinicalTrial: Clinical Trials.gov NCT01885052; https://clinicaltrials.gov/ct2/show/NCT01885052; (Archived by WebCite at http://www.webcitation.org/6iWzcmFdw) %M 27349898 %R 10.2196/resprot.5653 %U http://www.researchprotocols.org/2016/2/e134/ %U https://doi.org/10.2196/resprot.5653 %U http://www.ncbi.nlm.nih.gov/pubmed/27349898 %0 Journal Article %@ 2368-7959 %I JMIR Publications Inc. %V 3 %N 2 %P e13 %T Process and Effects Evaluation of a Digital Mental Health Intervention Targeted at Improving Occupational Well-Being: Lessons From an Intervention Study With Failed Adoption %A Muuraiskangas,Salla %A Harjumaa,Marja %A Kaipainen,Kirsikka %A Ermes,Miikka %+ VTT Technical Research Centre of Finland Ltd, Digital Health, Kaitoväylä 1, Oulu, 90590, Finland, 358 207222169, salla.muuraiskangas@vtt.fi %K acceptance and commitment therapy %K intervention studies %K mHealth %K cccupational health %K process assessment %K stress %K mindfulness %K attrition %K adoption %D 2016 %7 11.05.2016 %9 Original Paper %J JMIR Mental Health %G English %X Background: Digital interventions have the potential to serve as cost-effective ways to manage occupational stress and well-being. However, little is known about the adoption of individual-level digital interventions at organizations. Objectives: The aim of this paper is to study the effects of an unguided digital mental health intervention in occupational well-being and the factors that influence the adoption of the intervention. Methods: The intervention was based on acceptance and commitment therapy (ACT) and its aim was to teach skills for stress management and mental well-being. It was delivered via a mobile and a Web-based app that were offered to employees of two information and communication technology (ICT) companies. The primary outcome measures were perceived stress and work engagement, measured by a 1-item stress questionnaire (Stress) and the Utrecht Work Engagement Scale (UWES-9). The intervention process was evaluated regarding the change mechanisms and intervention stages using mixed methods. The initial interviews were conducted face-to-face with human resource managers (n=2) of both companies in August 2013. The participants were recruited via information sessions and email invitations. The intervention period took place between November 2013 and March 2014. The participants were asked to complete online questionnaires at baseline, two months, and four months after the baseline measurement. The final phone interviews for the volunteer participants (n=17) and the human resource managers (n=2) were conducted in April to May 2014, five months after the baseline. Results: Of all the employees, only 27 (8.1%, 27/332) took the app into use, with a mean use of 4.8 (SD 4.7) different days. In the beginning, well-being was on good level in both companies and no significant changes in well-being were observed. The activities of the intervention process failed to integrate the intervention into everyday activities at the workplace. Those who took the app into use experienced many benefits such as relief in stressful situations. The app was perceived as a toolkit for personal well-being that gives concrete instructions on how mindfulness can be practiced. However, many barriers to participate in the intervention were identified at the individual level, such as lack of time, lack of perceived need, and lack of perceived benefits. Conclusions: The findings suggest that neither the setting nor the approach used in this study were successful in adopting new digital interventions at the target organizations. Barriers were faced at both the organizational as well as the individual level. At the organizational level, top management needs to be involved in the intervention planning for fitting into the organization policies, the existing technology infrastructure, and also targeting the organizational goals. At the individual level, concretizing the benefits of the preventive intervention and arranging time for app use at the workplace are likely to increase adoption. %M 27170553 %R 10.2196/mental.4465 %U http://mental.jmir.org/2016/2/e13/ %U https://doi.org/10.2196/mental.4465 %U http://www.ncbi.nlm.nih.gov/pubmed/27170553 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 4 %P e131 %T Monitoring Web Site Usage of e-Bug: A Hygiene and Antibiotic Awareness Resource for Children %A Young,Vicki L %A Rajapandian,Vijayamaharaj %A Eley,Charlotte V %A Hoekstra,Beverley A %A Lecky,Donna M %A McNulty,Cliodna AM %+ Public Health England, Primary Care Unit, Microbiology Department, Gloucestershire Royal Hospital, Gloucester, GL1 3NN, United Kingdom, 44 300 422 5062, vicki.young@phe.gov.uk %K e-Bug %K educational resources %K public health %K antibiotics %D 2015 %7 13.11.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: e-Bug is an educational resource which teaches children and young people about microbes, hygiene, infection, and prudent antibiotic use. The e-Bug resources are available in over 22 different languages and they are used widely across the globe. The resources can be accessed from the e-Bug website. Objective: The objective of this study was to analyze the usage of the e-Bug website in order to understand how users access the website, where and when they access the site, and to review variation in use across the different areas of the site. Methods: The usage statistics for the e-Bug website were monitored by Google Analytics between September 2010 and August 2013. Results: The statistics show the website had over 324,000 visits during the three years, from just under 250,000 visitors, with the number of visitors increasing year after year. Visitors accessed the website from 211 different countries, with more than 267,000 documents downloaded. The majority of visitors were from the United Kingdom and visited the English website, although countries such as France and Portugal were also frequent visitors. Conclusions: These website statistics confirm that e-Bug is frequently used across Europe and highlight that e-Bug use has expanded across the world. The findings from this report will be used to inform future modifications or updates to the materials, as well as the development of new educational resources. %M 26567127 %R 10.2196/resprot.4049 %U http://www.researchprotocols.org/2015/4/e131/ %U https://doi.org/10.2196/resprot.4049 %U http://www.ncbi.nlm.nih.gov/pubmed/26567127 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 10 %P e201 %T Understanding Usage of a Hybrid Website and Smartphone App for Weight Management: A Mixed-Methods Study %A Morrison,Leanne G %A Hargood,Charlie %A Lin,Sharon Xiaowen %A Dennison,Laura %A Joseph,Judith %A Hughes,Stephanie %A Michaelides,Danius T %A Johnston,Derek %A Johnston,Marie %A Michie,Susan %A Little,Paul %A Smith,Peter WF %A Weal,Mark J %A Yardley,Lucy %+ Centre for Applications of Health Psychology, Academic Unit of Psychology, University of Southampton, Highfield Campus, Highfield, Southampton, SO17 1BJ, United Kingdom, 44 2380597222 ext 7222, l.morrison@soton.ac.uk %K qualitative research %K weight loss %K behavioral research %K mobile apps %K Internet %K health %K program acceptability %K behavior %K mixed-methods %D 2014 %7 22.10.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Advancements in mobile phone technology offer huge potential for enhancing the timely delivery of health behavior change interventions. The development of smartphone-based health interventions (apps) is a rapidly growing field of research, yet there have been few longitudinal examinations of how people experience and use these apps within their day-to-day routines, particularly within the context of a hybrid Web- and app-based intervention. Objective: This study used an in-depth mixed-methods design to examine individual variation in (1) impact on self-reported goal engagement (ie, motivation, self-efficacy, awareness, effort, achievement) of access to a weight management app (POWeR Tracker) when provided alongside a Web-based weight management intervention (POWeR) and (2) usage and views of POWeR Tracker. Methods: Thirteen adults were provided access to POWeR and were monitored over a 4-week period. Access to POWeR Tracker was provided in 2 alternate weeks (ie, weeks 1 and 3 or weeks 2 and 4). Participants’ goal engagement was measured daily via self-report. Mixed effects models were used to examine change in goal engagement between the weeks when POWeR Tracker was and was not available and whether the extent of change in goal engagement varied between individual participants. Usage of POWeR and POWeR Tracker was automatically recorded for each participant. Telephone interviews were conducted and analyzed using inductive thematic analysis to further explore participants’ experiences using POWeR and POWeR Tracker. Results: Access to POWeR Tracker was associated with a significant increase in participants’ awareness of their eating (β1=0.31, P=.04) and physical activity goals (β1=0.28, P=.03). The level of increase varied between individual participants. Usage data showed that participants used the POWeR website for similar amounts of time during the weeks when POWeR Tracker was (mean 29 minutes, SD 31 minutes) and was not available (mean 27 minutes, SD 33 minutes). POWeR Tracker was mostly accessed in short bursts (mean 3 minutes, SD 2 minutes) during convenient moments or moments when participants deemed the intervention content most relevant. The qualitative data indicated that nearly all participants agreed that it was more convenient to access information on-the-go via their mobiles compared to a computer. However, participants varied in their views and usage of the Web- versus app-based components and the informational versus tracking tools provided by POWeR Tracker. Conclusions: This study provides evidence that smartphones have the potential to improve individuals’ engagement with their health-related goals when used as a supplement to an existing online intervention. The perceived convenience of mobile access to information does not appear to deter use of Web-based interventions or strengthen the impact of app access on goal engagement. A mixed-methods design enabled exploration of individual variation in daily usage of the app-based tools. %M 25355131 %R 10.2196/jmir.3579 %U http://www.jmir.org/2014/10/e201/ %U https://doi.org/10.2196/jmir.3579 %U http://www.ncbi.nlm.nih.gov/pubmed/25355131 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 3 %P e31 %T Intervention Use and Action Planning in a Web-Based Computer-Tailored Weight Management Program for Overweight Adults: Randomized Controlled Trial %A van Genugten,Lenneke %A van Empelen,Pepijn %A Oenema,Anke %+ Erasmus University Medical Center, Department of Public Health, PO Box 2040, Rotterdam, 3000 CA, Netherlands, 31 107043721, l.vangenugten@erasmusmc.nl %K behavior change %K obesity %K health promotion %K intervention research %D 2014 %7 23.07.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: There are many online interventions aiming for health behavior change but it is unclear how such interventions and specific planning tools are being used. Objective: The aim of this study is to identify which user characteristics were associated with use of an online, computer-tailored self-regulation intervention aimed at prevention of weight gain; and to examine the quality of the goals and action plans that were generated using the online planning tools. Methods: Data were obtained with a randomized controlled effect evaluation trial in which the online computer-tailored intervention was compared to a website containing generic information about prevention of weight gain. The tailored intervention included self-regulation techniques such as personalized feedback, goal setting, action planning, monitoring, and other techniques aimed at weight management. Participants included 539 overweight adults (mean age 46.9 years, mean body mass index [BMI] 28.03 kg/m2, 31.2% male, 11% low education level) recruited from the general population. Use of the intervention and its planning tools were derived from server registration data. Physical activity, fat intake, motivational factors, and self-regulation skills were self-reported at baseline. Descriptive analyses and logistic regression analyses were used to analyze the results. Results: Use of the tailored intervention decreased sharply after the first modules. Visiting the first tailored intervention module was more likely among participants with low levels of fat intake (OR 0.77, 95% CI 0.62-0.95) or planning for change in PA (OR 0.23, 95% CI 0.05-0.97). Revisiting the intervention was more likely among participants high in restrained eating (OR 2.45, 95% CI 1.12-5.43) or low in proactive coping skills for weight control (OR 0.28, 95% CI 0.10-0.76). The planning tools were used by 5%-55% of the participants, but only 20%-75% of the plans were of good quality. Conclusions: This study showed that psychological factors such as self-regulation skills and action planning were associated with repeated use of an online, computer-tailored self-regulation intervention aimed at prevention of weight gain among adults being overweight. Use of the intervention was not optimal, with a limited number of participants who visited all the intervention modules. The use of the action and coping planning components of the intervention was mediocre and the quality of the generated plans was low, especially for the coping plans. It is important to identify how the use of action planning and coping planning components in online interventions can be promoted and how the quality of plans generated through these tools can be improved. Trial Registration: Netherlands Trial Register: NTR1862; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1862 (Archived by WebCite at http://www.webcitation.org/6QG1ZPIzZ). %M 25057122 %R 10.2196/resprot.2599 %U http://www.researchprotocols.org/2014/3/e31/ %U https://doi.org/10.2196/resprot.2599 %U http://www.ncbi.nlm.nih.gov/pubmed/25057122 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 16 %N 4 %P e111 %T Usage and Effectiveness of a Fully Automated, Open-Access, Spanish Web-Based Smoking Cessation Program: Randomized Controlled Trial %A Mañanes,Guillermo %A Vallejo,Miguel A %+ Faculty of Psychology, Department of Clinical Psychology, National Distance Education University (UNED), Juan del Rosal 10, Madrid, 28040, Spain, 34 913987936, mvallejo@psi.uned.es %K smoking cessation %K Internet %K intervention studies %D 2014 %7 23.04.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: The Internet is an optimal setting to provide massive access to tobacco treatments. To evaluate open-access Web-based smoking cessation programs in a real-world setting, adherence and retention data should be taken into account as much as abstinence rate. Objective: The objective was to analyze the usage and effectiveness of a fully automated, open-access, Web-based smoking cessation program by comparing interactive versus noninteractive versions. Methods: Participants were randomly assigned either to the interactive or noninteractive version of the program, both with identical content divided into 4 interdependent modules. At baseline, we collected demographic, psychological, and smoking characteristics of the smokers self-enrolled in the Web-based program of Universidad Nacional de Educación a Distancia (National Distance Education University; UNED) in Madrid, Spain. The following questionnaires were administered: the anxiety and depression subscales from the Symptom Checklist-90-Revised, the 4-item Perceived Stress Scale, and the Heaviness of Smoking Index. At 3 months, we analyzed dropout rates, module completion, user satisfaction, follow-up response rate, and self-assessed smoking abstinence. Results: A total of 23,213 smokers were registered, 50.06% (11,620/23,213) women and 49.94% (11,593/23,213) men, with a mean age of 39.5 years (SD 10.3). Of these, 46.10% (10,701/23,213) were married and 34.43% (7992/23,213) were single, 46.03% (10,686/23,213) had university education, and 78.73% (18,275/23,213) were employed. Participants smoked an average of 19.4 cigarettes per day (SD 10.3). Of the 11,861 smokers randomly assigned to the interactive version, 2720 (22.93%) completed the first module, 1052 (8.87%) the second, 624 (5.26%) the third, and 355 (2.99%) the fourth. Completion data was not available for the noninteractive version (no way to record it automatically). The 3-month follow-up questionnaire was completed by 1085 of 23,213 enrolled smokers (4.67%). Among them, 406 (37.42%) self-reported not smoking. No difference between groups was found. Assuming missing respondents continued to smoke, the abstinence rate was 1.74% (406/23,213), in which 22,678 were missing respondents. Among follow-up respondents, completing the 4 modules of the intervention increased the chances of smoking cessation (OR 1.95, 95% CI 1.27-2.97, P<.001), as did smoking 30 minutes (OR 1.58, 95% CI 1.04-2.39, P=.003) or 1 hour after waking (OR 1.93, 95% CI 1.27-2.93, P<.001) compared to smoking within the first 5 minutes after waking. Conclusions: The findings suggest that the UNED Web-based smoking cessation program was very accessible, but a high level of attrition was confirmed. This could be related to the ease of enrollment, its free character, and the absence of direct contact with professionals. It is concluded that, in practice, the greater the accessibility to the program, the lower the adherence and retention. Professional support from health services and the payment of a reimbursable fee could prevent high rates of attrition. %M 24760951 %R 10.2196/jmir.3091 %U http://www.jmir.org/2014/4/e111/ %U https://doi.org/10.2196/jmir.3091 %U http://www.ncbi.nlm.nih.gov/pubmed/24760951 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 1 %P e27 %T Understanding the Usage of Content in a Mental Health Intervention for Depression: An Analysis of Log Data %A Van Gemert-Pijnen,Julia EWC %A Kelders,Saskia M %A Bohlmeijer,Ernst T %+ University of Twente, Department of Psychology, Health and Technology, Drienerlolaan 5, Enschede, 7522 NB, Netherlands, 31 534896050, j.vangemert-pijnen@utwente.nl %K mental health %K depression %K Web-based intervention %K acceptance commitment therapy %D 2014 %7 31.01.2014 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-based interventions for the early treatment of depressive symptoms can be considered effective in reducing mental complaints. However, there is a limited understanding of which elements in an intervention contribute to effectiveness. For efficiency and effectiveness of interventions, insight is needed into the use of content and persuasive features. Objective: The aims of this study were (1) to illustrate how log data can be used to understand the uptake of the content of a Web-based intervention that is based on the acceptance and commitment therapy (ACT) and (2) to discover how log data can be of value for improving the incorporation of content in Web-based interventions. Methods: Data from 206 participants (out of the 239) who started the first nine lessons of the Web-based intervention, Living to the Full, were used for a secondary analysis of a subset of the log data of the parent study about adherence to the intervention. The log files used in this study were per lesson: login, start mindfulness, download mindfulness, view success story, view feedback message, start multimedia, turn on text-message coach, turn off text-message coach, and view text message. Differences in usage between lessons were explored with repeated measures ANOVAs (analysis of variance). Differences between groups were explored with one-way ANOVAs. To explore the possible predictive value of the login per lesson quartiles on the outcome measures, four linear regressions were used with login quartiles as predictor and with the outcome measures (Center for Epidemiologic Studies—Depression [CES-D] and the Hospital Anxiety and Depression Scale—Anxiety [HADS-A] on post-intervention and follow-up) as dependent variables. Results: A significant decrease in logins and in the use of content and persuasive features over time was observed. The usage of features varied significantly during the treatment process. The usage of persuasive features increased during the third part of the ACT (commitment to value-based living), which might indicate that at that stage motivational support was relevant. Higher logins over time (9 weeks) corresponded with a higher usage of features (in most cases significant); when predicting depressive symptoms at post-intervention, the linear regression yielded a significant model with login quartile as a significant predictor (explained variance is 2.7%). Conclusions: A better integration of content and persuasive features in the design of the intervention and a better intra-usability of features within the system are needed to identify which combination of features works best for whom. Pattern recognition can be used to tailor the intervention based on usage patterns from the earlier lessons and to support the uptake of content essential for therapy. An adaptable interface for a modular composition of therapy features supposes a dynamic approach for Web-based treatment; not a predefined path for all, but a flexible way to go through all features that have to be used. %M 24486914 %R 10.2196/jmir.2991 %U http://www.jmir.org/2014/1/e27/ %U https://doi.org/10.2196/jmir.2991 %U http://www.ncbi.nlm.nih.gov/pubmed/24486914 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 10 %P e231 %T Rethinking the Dose-Response Relationship Between Usage and Outcome in an Online Intervention for Depression: Randomized Controlled Trial %A Donkin,Liesje %A Hickie,Ian B %A Christensen,Helen %A Naismith,Sharon L %A Neal,Bruce %A Cockayne,Nicole L %A Glozier,Nick %+ Brain & Mind Research Institute, The University of Sydney, 100 Mallet Street, Camperdown, NSW, New South Wales, 2050, Australia, 61 21847886, Liesje.Donkin@sydney.edu.au %K adherence %K Internet %K eHealth %K depression %K patient compliance %D 2013 %7 17.10.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: There is now substantial evidence that Web-based interventions can be effective at changing behavior and successfully treating psychological disorders. However, interest in the impact of usage on intervention outcomes has only been developed recently. To date, persistence with or completion of the intervention has been the most commonly reported metric of use, but this does not adequately describe user behavior online. Analysis of alternative measures of usage and their relationship to outcome may help to understand how much of the intervention users may need to obtain a clinically significant benefit from the program. Objective: The objective of this study was to determine which usage metrics, if any, are associated with outcome in an online depression treatment trial. Methods: Cardiovascular Risk E-couch Depression Outcome (CREDO) is a randomized controlled trial evaluating an unguided Web-based program (E-couch) based on cognitive behavioral therapy and interpersonal therapy for people with depression and cardiovascular disease. In all, 280 participants in the active arm of the trial commenced the program, delivered in 12 modules containing pages of text and activities. Usage data (eg, number of log-ins, modules completed, time spent online, and activities completed) were captured automatically by the program interface. We estimated the association of these and composite metrics with the outcome of a clinically significant improvement in depression score on the Patient Health Questionnaire (PHQ-9) of ≥5 points. Results: In all, 214/280 (76.4%) participants provided outcome data at the end of the 12-week period and were included in the analysis. Of these, 94 (43.9%) participants obtained clinically significant improvement. Participants logged into the program an average of 18.7 times (SD 8.3) with most (62.1%, 133/214) completing all 12 modules. Average time spent online per log-in was 17.3 minutes (SD 10.5). Participants completed an average of 9 of 18 activities available within the program. In a multivariate regression model, only the number of activities completed per log-in was associated with a clinically significant outcome (OR 2.82, 95% CI 1.05-7.59). The final model predicted 7.4% of variance in outcome. Curve estimates indicated that significant logarithmic (P=.009) and linear (P=.002) relationships existed between activities completed per log-in and clinically significant change. Conclusions: Only one objective measure of usage was independently associated with better outcome of a Web-based intervention of known effectiveness. The 4 usage metrics retained in the final step of the regression accounted for little outcome variance. Medium level users appeared to have little additional benefit compared to low users indicating that assumptions of a linear relationship between use and outcome may be too simplistic and further models and variables need to be explored to adequately understand the relationship. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12610000085077; http://www.anzctr.org.au/ACTRN12610000085077.aspx (Archived by WebCite at http://www.webcitation.org/6K9FQtKBn). %M 24135213 %R 10.2196/jmir.2771 %U http://www.jmir.org/2013/10/e231/ %U https://doi.org/10.2196/jmir.2771 %U http://www.ncbi.nlm.nih.gov/pubmed/24135213 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 8 %P e172 %T Participants, Usage, and Use Patterns of a Web-Based Intervention for the Prevention of Depression Within a Randomized Controlled Trial %A Kelders,Saskia M %A Bohlmeijer,Ernst T %A Van Gemert-Pijnen,Julia EWC %+ Department of Psychology, Health and Technology, University of Twente, PO Box 217, Enschede, 7500 AE, Netherlands, 31 651070689, s.m.kelders@utwente.nl %K Web-based intervention %K depression %K use patterns %K usage %K adherence %K design %K engagement %K attrition %D 2013 %7 20.08.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Although Web-based interventions have been shown to be effective, they are not widely implemented in regular care. Nonadherence (ie, participants not following the intervention protocol) is an issue. By studying the way Web-based interventions are used and whether there are differences between adherers (ie, participants that started all 9 lessons) and nonadherers, more insight can be gained into the process of adherence. Objective: The aims of this study were to (1) describe the characteristics of participants and investigate their relationship with adherence, (2) investigate the utilization of the different features of the intervention and possible differences between adherers and nonadherers, and (3) identify what use patterns emerge and whether there are differences between adherers and nonadherers. Methods: Data were used from 206 participants that used the Web-based intervention Living to the full, a Web-based intervention for the prevention of depression employing both a fully automated and human-supported format. Demographic and baseline characteristics of participants were collected by using an online survey. Log data were collected within the Web-based intervention itself. Both quantitative and qualitative analyses were performed. Results: In all, 118 participants fully adhered to the intervention (ie, started all 9 lessons). Participants with an ethnicity other than Dutch were more often adherers (χ21=5.5, P=.02), and nonadherers used the Internet more hours per day on average (F1,203=3.918, P=.049). A logistic regression showed that being female (OR 2.02, 95% CI 1.01-4.04; P=.046) and having a higher need for cognition (OR 1.02; 95% CI 1.00-1.05; P=.02) increased the odds of adhering to the intervention. Overall, participants logged in an average of 4 times per lesson, but adherers logged in significantly more times per lesson than nonadherers (F1,204=20.710; P<.001). For use patterns, we saw that early nonadherers seemed to use fewer sessions and spend less time than late nonadherers and adherers, and fewer sessions to complete the lesson than adherers. Furthermore, late nonadherers seemed to have a shorter total duration of sessions than adherers. Conclusions: By using log data combined with baseline characteristics of participants, we extracted valuable lessons for redesign of this intervention and the design of Web-based interventions in general. First, although characteristics of respondents can significantly predict adherence, their predictive value is small. Second, it is important to design Web-based interventions to foster adherence and usage of all features in an intervention. Trial Registration: Dutch Trial Register Number: NTR3007; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3007 (Archived by WebCite at http://www.webcitation.org/6ILhI3rd8). %M 23963284 %R 10.2196/jmir.2258 %U http://www.jmir.org/2013/8/e172/ %U https://doi.org/10.2196/jmir.2258 %U http://www.ncbi.nlm.nih.gov/pubmed/23963284 %0 Journal Article %@ 14388871 %I JMIR Publications Inc. %V 15 %N 8 %P e170 %T Usage of a Generic Web-Based Self-Management Intervention for Breast Cancer Survivors: Substudy Analysis of the BREATH Trial %A van den Berg,Sanne W %A Peters,Esmee J %A Kraaijeveld,J Frank %A Gielissen,Marieke FM %A Prins,Judith B %+ Department of Medical Psychology, Radboud University Nijmegen Medical Centre, PO Box 9101, Nijmegen, 6500 HB, Netherlands, 31 24 36 13608, s.vandenberg@mps.umcn.nl %K usage evaluation %K usage statistics %K intervention adherence %K user groups %K exposure %K Internet %K Web-based intervention %K breast cancer %K log file analysis %K website use %D 2013 %7 19.08.2013 %9 Original Paper %J J Med Internet Res %G English %X Background: Generic fully automated Web-based self-management interventions are upcoming, for example, for the growing number of breast cancer survivors. It is hypothesized that the use of these interventions is more individualized and that users apply a large amount of self-tailoring. However, technical usage evaluations of these types of interventions are scarce and practical guidelines are lacking. Objective: To gain insight into meaningful usage parameters to evaluate the use of generic fully automated Web-based interventions by assessing how breast cancer survivors use a generic self-management website. Final aim is to propose practical recommendations for researchers and information and communication technology (ICT) professionals who aim to design and evaluate the use of similar Web-based interventions. Methods: The BREAst cancer ehealTH (BREATH) intervention is a generic unguided fully automated website with stepwise weekly access and a fixed 4-month structure containing 104 intervention ingredients (ie, texts, tasks, tests, videos). By monitoring https-server requests, technical usage statistics were recorded for the intervention group of the randomized controlled trial. Observed usage was analyzed by measures of frequency, duration, and activity. Intervention adherence was defined as continuous usage, or the proportion of participants who started using the intervention and continued to log in during all four phases. By comparing observed to minimal intended usage (frequency and activity), different user groups were defined. Results: Usage statistics for 4 months were collected from 70 breast cancer survivors (mean age 50.9 years). Frequency of logins/person ranged from 0 to 45, total duration/person from 0 to 2324 minutes (38.7 hours), and activity from opening none to all intervention ingredients. 31 participants continued logging in to all four phases resulting in an intervention adherence rate of 44.3% (95% CI 33.2-55.9). Nine nonusers (13%), 30 low users (43%), and 31 high users (44%) were defined. Low and high users differed significantly on frequency (P<.001), total duration (P<.001), session duration (P=.009), and activity (P<.001). High users logged in an average of 21 times, had a mean session duration of 33 minutes, and opened on average 91% of all ingredients. Signing the self-help contract (P<.001), reporting usefulness of ingredients (P=.003), overall satisfaction (P=.028), and user friendliness evaluation (P=.003) were higher in high users. User groups did not differ on age, education, and baseline distress. Conclusions: By reporting the usage of a self-management website for breast cancer survivors, the present study gained first insight into the design of usage evaluations of generic fully automated Web-based interventions. It is recommended to (1) incorporate usage statistics that reflect the amount of self-tailoring applied by users, (2) combine technical usage statistics with self-reported usefulness, and (3) use qualitative measures. Also, (4) a pilot usage evaluation should be a fixed step in the development process of novel Web-based interventions, and (5) it is essential for researchers to gain insight into the rationale of recorded and nonrecorded usage statistics. Trial Registration: Netherlands Trial Register (NTR): 2935; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2935 (Archived by WebCite at http://www.webcitation.org/6IkX1ADEV). %M 23958584 %R 10.2196/jmir.2566 %U http://www.jmir.org/2013/8/e170/ %U https://doi.org/10.2196/jmir.2566 %U http://www.ncbi.nlm.nih.gov/pubmed/23958584 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 1 %N 2 %P e16 %T Personal Health Technologies in Employee Health Promotion: Usage Activity, Usefulness, and Health-Related Outcomes in a 1-Year Randomized Controlled Trial %A Mattila,Elina %A Orsama,Anna-Leena %A Ahtinen,Aino %A Hopsu,Leila %A Leino,Timo %A Korhonen,Ilkka %+ VTT Technical Research Centre of Finland, PO Box 1300, Tampere, 33101, Finland, 358 207223384, elina.m.mattila@vtt.fi %K health promotion %K intervention %K Internet %K mobile phones %K device %K risk factors %K health technology %D 2013 %7 29.07.2013 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Common risk factors such as obesity, poor nutrition, physical inactivity, stress, and sleep deprivation threaten the wellness and work ability of employees. Personal health technologies may help improve engagement in health promotion programs and maintenance of their effect. Objective: This study investigated personal health technologies in supporting employee health promotion targeting multiple behavioral health risks. We studied the relations of usage activity to demographic and physiological characteristics, health-related outcomes (weight, aerobic fitness, blood pressure and cholesterol), and the perceived usefulness of technologies in wellness management. Methods: We conducted a subgroup analysis of the technology group (114 subjects, 33 males, average age 45 years, average BMI 27.1 kg/m2) of a 3-arm randomized controlled trial (N=352). The trial was organized to study the efficacy of a face-to-face group intervention supported by technologies, including Web services, mobile applications, and personal monitoring devices. Technology usage was investigated based on log files and questionnaires. The associations between sustained usage of Web and mobile technologies and demographic and physiological characteristics were analyzed by comparing the baseline data of sustained and non-sustained users. The associations between sustained usage and changes in health-related outcomes were studied by repeated analysis of variance, using data measured by baseline and end questionnaires, and anthropometric and laboratory measurements. The experienced usability, usefulness, motivation, and barriers to using technologies were investigated by 4 questionnaires and 2 interviews. Results: 111 subjects (97.4%) used technologies at some point of the study, and 33 (29.9%) were classified as sustained users of Web or mobile technologies. Simple technologies, weight scales and pedometer, attracted the most users. The sustained users were slightly older 47 years (95% CI 44 to 49) versus 44 years (95% CI 42 to 45), P=.034 and had poorer aerobic fitness at baseline (mean difference in maximal metabolic equivalent 1.0, 95% Cl 0.39 to 1.39; P=.013) than non-sustained users. They succeeded better in weight management: their weight decreased -1.2 kg (95% CI -2.38 to -0.01) versus +0.6 kg (95% CI -0.095 to 1.27), P=.006; body fat percentage -0.9%-units (95% CI -1.64 to -0.09) versus +0.3%-units (95% CI -0.28 to 0.73), P=.014; and waist circumference -1.4 cm (95% CI -2.60 to -0.20) versus +0.7 cm (95% CI -0.21 to 1.66), P=.01. They also participated in intervention meetings more actively: median 4 meetings (interquartile range; IQR 4–5) versus 4 meetings (IQR 3–4), P=.009. The key factors in usefulness were: simplicity, integration into daily life, and clear feedback on progress. Conclusions: Despite active initial usage, less than 30% of subjects continued using Web or mobile technologies throughout the study. Sustained users achieved better weight-related outcomes than non-sustained users. High non-usage attrition and modest outcomes cast doubt on the potential of technologies to support interventions. %M 25098385 %R 10.2196/mhealth.2557 %U http://mhealth.jmir.org/2013/2/e16/ %U https://doi.org/10.2196/mhealth.2557 %U http://www.ncbi.nlm.nih.gov/pubmed/25098385