Usability and preliminary effectiveness of an app-based physical activity and education program for people with hip or knee osteoarthritis - a pilot randomized controlled trial.

BACKGROUND: Hip and knee osteoarthritis (OA) are highly prevalent worldwide. The guidelines recommend physical activity and education as the core treatments for osteoarthritis. Digital health has the potential to engage people in physical activity and disease management. Therefore, we conducted a pilot trial to assess the usability and preliminary effectiveness of an app-based physical activity and education program (Join2Move) compared to usual care for people with hip and/or knee OA in Germany. METHODS: A randomized controlled pilot study was conducted. Individuals with diagnosed or self-reported knee and hip OA were included. Allocation to the intervention or control group was randomized. The intervention group received the Join2Move program. The Join2Move program was previously developed as a website and evaluated in the Netherlands. For the current study, the program was translated and adapted to the German context and adjusted from a website to an app. The control group received usual care. The primary outcomes were usability and preliminary effectiveness (pain and physical functioning). Measurements were taken at baseline and at twelve weeks. The data analysis was performed using SPSS (IBM SPSS Statistics 29.0). RESULTS: Sixty participants, with a mean age of 61.9 (SD ± 7.2) years, were allocated to the intervention (n = 32) or the control group (n = 28) and included in the analysis. The majority of participants had knee OA (68%), and 12% had hip and knee OA. The dropout rate was n = 11 (18%). No adverse events were reported. Usability was rated as acceptable (mean System Usability Scale = 71.3/100) with a wide range (32.5 to 100). Statistically significant between-group differences were found only for pain (mean difference 8.52 (95% CI 1.01 to 16.04), p = 0.027). CONCLUSIONS: Join2Move demonstrated acceptable usability. The preliminary results of the pilot trial indicate the potential of a stand-alone app for the treatment of patients with hip or knee OA. However, the acceptable usability of Join2Move limits its recommendation for everyone. There appears to be room for improvement in app usability and in identifying patients for whom the app is suitable and the right time to use a stand-alone app. TRIAL REGISTRATION: German Clinical Trials Register DRKS00027164 .

Adoption and Use of Telemedicine and Digital Health Services Among Older Adults in Light of the COVID-19 Pandemic: Repeated Cross-Sectional Analysis.

BACKGROUND: As the population ages and the prevalence of long-term diseases rises, the use of telecare is becoming increasingly frequent to aid older people. OBJECTIVE: This study aims to explore the use and adoption of 3 types of telehealth services among the older population in Israel before, during, and after the COVID-19 pandemic. METHODS: We explored the use characteristics of older adults (aged ≥65 years) belonging to Clalit Health Services in several aspects in the use of 3 types of telehealth services: the use of digital services for administrative tasks; the use of synchronous working-hours telehealth visits with the patient's personal physician during clinic business hours; and the use of after-hours consultations during evenings, nights, and weekends when the clinics are closed. The data were collected and analyzed throughout 3 distinct periods in Israel: before the COVID-19 pandemic, during the onset of the COVID-19 pandemic, and following the COVID-19 peak. RESULTS: Data of 618,850 patients who met the inclusion criteria were extracted. Telehealth services used for administrative purposes were the most popular. The most intriguing finding was that the older population significantly increased their use of all types of telehealth services during the COVID-19 pandemic, and in most types, this use decreased after the COVID-19 peak, but to a level that was higher than the baseline level before the COVID-19 pandemic. Before the COVID-19 pandemic, 23.1% (142,936/618,850) of the study population used working-hours telehealth visits, and 2.2% (13,837/618,850) used after-hours consultations at least once. The percentage of use for these services increased during the COVID-19 pandemic to 59.2% (366,566/618,850) and 5% (30,777/618,850) and then decreased during the third period to 39.5% (244,572/618,850) and 2.4% (14,584/618,850), respectively (P<.001). Multiple patient variables have been found to be associated with the use of the different telehealth services in each period. CONCLUSIONS: Despite the limitations and obstacles, the older population uses telehealth services and can increase their use when they are needed. These people can learn how to use digital health services effectively, and they should be given the opportunity to do so by creating suitable and straightforward telehealth solutions tailored to this population and enhancing their usability.

Behavior Change Approaches in Digital Technology-Based Physical Rehabilitation Interventions Following Stroke: Scoping Review.

BACKGROUND: Digital health technologies (DHTs) are increasingly used in physical stroke rehabilitation to support individuals in successfully engaging with the frequent, intensive, and lengthy activities required to optimize recovery. Despite this, little is known about behavior change within these interventions. OBJECTIVE: This scoping review aimed to identify if and how behavior change approaches (ie, theories, models, frameworks, and techniques to influence behavior) are incorporated within physical stroke rehabilitation interventions that include a DHT. METHODS: Databases (Embase, MEDLINE, PsycINFO, CINAHL, Cochrane Library, and AMED) were searched using keywords relating to behavior change, DHT, physical rehabilitation, and stroke. The results were independently screened by 2 reviewers. Sources were included if they reported a completed primary research study in which a behavior change approach could be identified within a physical stroke rehabilitation intervention that included a DHT. Data, including the study design, DHT used, and behavior change approaches, were charted. Specific behavior change techniques were coded to the behavior change technique taxonomy version 1 (BCTTv1). RESULTS: From a total of 1973 identified sources, 103 (5%) studies were included for data charting. The most common reason for exclusion at full-text screening was the absence of an explicit approach to behavior change (165/245, 67%). Almost half (45/103, 44%) of the included studies were described as pilot or feasibility studies. Virtual reality was the most frequently identified DHT type (58/103, 56%), and almost two-thirds (65/103, 63%) of studies focused on upper limb rehabilitation. Only a limited number of studies (18/103, 17%) included a theory, model, or framework for behavior change. The most frequently used BCTTv1 clusters were feedback and monitoring (88/103, 85%), reward and threat (56/103, 54%), goals and planning (33/103, 32%), and shaping knowledge (33/103, 32%). Relationships between feedback and monitoring and reward and threat were identified using a relationship map, with prominent use of both of these clusters in interventions that included virtual reality. CONCLUSIONS: Despite an assumption that DHTs can promote engagement in rehabilitation, this scoping review demonstrates that very few studies of physical stroke rehabilitation that include a DHT overtly used any form of behavior change approach. From those studies that did consider behavior change, most did not report a robust underpinning theory. Future development and research need to explicitly articulate how including DHTs within an intervention may support the behavior change required for optimal engagement in physical rehabilitation following stroke, as well as establish their effectiveness. This understanding is likely to support the realization of the transformative potential of DHTs in stroke rehabilitation.

The Impact of Digital Self-Monitoring of Weight on Improving Diabetes Clinical Outcomes: Quasi-Randomized Study.

BACKGROUND: The management of type 2 diabetes (T2D) and obesity, particularly in the context of self-monitoring, remains a critical challenge in health care. As nearly 80% to 90% of patients with T2D have overweight or obesity, there is a compelling need for interventions that can effectively manage both conditions simultaneously. One of the goals in managing chronic conditions is to increase awareness and generate behavioral change to improve outcomes in diabetes and related comorbidities, such as overweight or obesity. There is a lack of real-life evidence to test the impact of self-monitoring of weight on glycemic outcomes and its underlying mechanisms. OBJECTIVE: This study aims to assess the efficacy of digital self-monitoring of weight on blood glucose (BG) levels during diabetes management, investigating whether the weight changes may drive glucose fluctuations. METHODS: In this retrospective, real-world quasi-randomized study, 50% of the individuals who regularly used the weight monitoring (WM) feature were propensity score matched with 50% of the users who did not use the weight monitoring feature (NWM) based on demographic and clinical characteristics. All the patients were diagnosed with T2D and tracked their BG levels. We analyzed monthly aggregated data 6 months before and after starting their weight monitoring. A piecewise mixed model was used for analyzing the time trajectories of BG and weight as well as exploring the disaggregation effect of between- and within-patient lagged effects of weight on BG. RESULTS: The WM group exhibited a significant reduction in BG levels post intervention (P<.001), whereas the nonmonitoring group showed no significant changes (P=.59), and both groups showed no differences in BG pattern before the intervention (P=.59). Furthermore, the WM group achieved a meaningful decrease in BMI (P<.001). Finally, both within-patient (P<.001) and between-patient (P=.008) weight variability was positively associated with BG levels. However, 1-month lagged back BMI was not associated with BG levels (P=.36). CONCLUSIONS: This study highlights the substantial benefits of self-monitoring of weight in managing BG levels in patients with diabetes, facilitated by a digital health platform, and advocates for the integration of digital self-monitoring tools in chronic disease management. We also provide initial evidence of testing the underlying mechanisms associated with BG management, underscoring the potential role of patient empowerment.

The PICOTS-ComTeC Framework for Defining Digital Health Interventions: An ISPOR Special Interest Group Report.

OBJECTIVES: Digital health definitions are abundant, but often lack clarity and precision. We aimed to develop a minimum information framework to define patient-facing digital health interventions (DHIs) for outcomes research. METHODS: Definitions of digital-health-related terms (DHTs) were systematically reviewed, followed by a content analysis using frameworks, including PICOTS (population, intervention, comparator, outcome, timing, and setting), Shannon-Weaver Model of Communication, Agency for Healthcare Research and Quality Measures, and the World Health Organization's Classification of Digital Health Interventions. Subsequently, we conducted an online Delphi study to establish a minimum information framework, which was pilot tested by 5 experts using hypothetical examples. RESULTS: After screening 2610 records and 545 full-text articles, we identified 101 unique definitions of 67 secondary DHTs in 76 articles, resulting in 95 different patterns of concepts among the definitions. World Health Organization system (84.5%), message (75.7%), intervention (58.3%), and technology (52.4%) were the most frequently covered concepts. For the Delphi survey, we invited 47 members of the ISPOR Digital Health Special Interest Group, 18 of whom became the Delphi panel. The first, second, and third survey rounds were completed by 18, 11, and 10 respondents, respectively. After consolidating results, the PICOTS-ComTeC acronym emerged, involving 9 domains (population, intervention, comparator, outcome, timing, setting, communication, technology, and context) and 32 optional subcategories. CONCLUSIONS: Patient-facing DHIs can be specified using PICOTS-ComTeC that facilitates identification of appropriate interventions and comparators for a given decision. PICOTS-ComTeC is a flexible and versatile tool, intended to assist authors in designing and reporting primary studies and evidence syntheses, yielding actionable results for clinicians and other decision makers.

Digital Therapeutic (Mika) Targeting Distress in Patients With Cancer: Results From a Nationwide Waitlist Randomized Controlled Trial.

BACKGROUND: Distress is highly prevalent among patients with cancer, but supportive care needs often go unmet. Digital therapeutics hold the potential to overcome barriers in cancer care and improve health outcomes. OBJECTIVE: This study conducted a randomized controlled trial to investigate the efficacy of Mika, an app-based digital therapeutic designed to reduce distress across the cancer trajectory. METHODS: This nationwide waitlist randomized controlled trial in Germany enrolled patients with cancer across all tumor entities diagnosed within the last 5 years. Participants were randomized into the intervention (Mika plus usual care) and control (usual care alone) groups. The participants completed web-based assessments at baseline and at 2, 6, and 12 weeks. The primary outcome was the change in distress from baseline to week 12, as measured by the National Comprehensive Cancer Network Distress Thermometer. Secondary outcomes included depression, anxiety (Hospital Anxiety and Depression Scale), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), and quality of life (Clinical Global Impression-Improvement Scale). Intention-to-treat and per-protocol analyses were performed. Analyses of covariance were used to test for outcome changes over time between the groups, controlling for baseline. RESULTS: A total of 218 patients (intervention: n=99 and control: n=119) were included in the intention-to-treat analysis. Compared with the control group, the intervention group reported greater reductions in distress (P=.03; ηp²=0.02), depression (P<.001; ηp²=0.07), anxiety (P=.03; ηp²=0.02), and fatigue (P=.04; ηp²=0.02). Per-protocol analyses revealed more pronounced treatment effects, with the exception of fatigue. No group difference was found for quality of life. CONCLUSIONS: Mika effectively diminished distress in patients with cancer. As a digital therapeutic solution, Mika offers accessible, tailored psychosocial and self-management support to address the unmet needs in cancer care. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00026038; https://drks.de/search/en/trial/DRKS00026038.

Remote Short Sessions of Heart Rate Variability Biofeedback Monitored With Wearable Technology: Open-Label Prospective Feasibility Study.

BACKGROUND: Heart rate variability (HRV) biofeedback is often performed with structured education, laboratory-based assessments, and practice sessions. It has been shown to improve psychological and physiological function across populations. However, a means to remotely use and monitor this approach would allow for wider use of this technique. Advancements in wearable and digital technology present an opportunity for the widespread application of this approach. OBJECTIVE: The primary aim of the study was to determine the feasibility of fully remote, self-administered short sessions of HRV-directed biofeedback in a diverse population of health care workers (HCWs). The secondary aim was to determine whether a fully remote, HRV-directed biofeedback intervention significantly alters longitudinal HRV over the intervention period, as monitored by wearable devices. The tertiary aim was to estimate the impact of this intervention on metrics of psychological well-being. METHODS: To determine whether remotely implemented short sessions of HRV biofeedback can improve autonomic metrics and psychological well-being, we enrolled HCWs across 7 hospitals in New York City in the United States. They downloaded our study app, watched brief educational videos about HRV biofeedback, and used a well-studied HRV biofeedback program remotely through their smartphone. HRV biofeedback sessions were used for 5 minutes per day for 5 weeks. HCWs were then followed for 12 weeks after the intervention period. Psychological measures were obtained over the study period, and they wore an Apple Watch for at least 7 weeks to monitor the circadian features of HRV. RESULTS: In total, 127 HCWs were enrolled in the study. Overall, only 21 (16.5%) were at least 50% compliant with the HRV biofeedback intervention, representing a small portion of the total sample. This demonstrates that this study design does not feasibly result in adequate rates of compliance with the intervention. Numerical improvement in psychological metrics was observed over the 17-week study period, although it did not reach statistical significance (all P>.05). Using a mixed effect cosinor model, the mean midline-estimating statistic of rhythm (MESOR) of the circadian pattern of the SD of the interbeat interval of normal sinus beats (SDNN), an HRV metric, was observed to increase over the first 4 weeks of the biofeedback intervention in HCWs who were at least 50% compliant. CONCLUSIONS: In conclusion, we found that using brief remote HRV biofeedback sessions and monitoring its physiological effect using wearable devices, in the manner that the study was conducted, was not feasible. This is considering the low compliance rates with the study intervention. We found that remote short sessions of HRV biofeedback demonstrate potential promise in improving autonomic nervous function and warrant further study. Wearable devices can monitor the physiological effects of psychological interventions.

A perspective on digital health platform design and its implementation at national level.

Accessible and affordable health services and products including medicines, vaccines, and public health are an important health agenda of all countries. It is well understood that without digital health technologies, countries will face difficulties in tackling the needs and demands of their population. Global agencies including the World Health Organization (WHO), United Nations (UN), International Telecommunication Union (ITU), etc. have been instrumental in providing various tools, and guidance through digital health strategies in improving health and digital health maturity of the countries. The Digital Health Platform Handbook (DHPH) is a toolkit published by WHO and ITU to help countries create and implement a digital health platform (DHP) to serve as the underlying infrastructure for an interoperable and integrated national digital health system. We apply the foundational principles of DHPH and provide a perspective of DHP components in a layered, enterprise architecture of a digital health infrastructure. India has rolled out the blueprint of its National Digital Health Mission (NDHM) to address the emerging needs for digitization of healthcare in the country. In this paper, we also illustrate the design and implementation of WHO-ITU DHP components at the national level by exploring India's digital health mission implementation utilizing various digital public goods to build a digital health ecosystem in the country.

Critical success factors for creating sustainable digital health applications: A systematic review of the German case.

Objective: The Covid-19 pandemic has accelerated the adoption of digital technologies to address social needs, leading to increased investments in digital healthcare applications. Germany implemented a special law called the "Digitales Versorgungsgesetz" (DVG-Digital Supply Act) in 2019, which enables the reimbursement of digital health applications, including digital therapeutics (DTx), through a fast-track process. The Federal Institute for Drugs and Medical Devices (BfArM), the German federal authority responsible for overseeing digital health applications, has implemented legislative adjustments since the law's introduction, which have increased requirements for these applications and potentially led to the removal of some from the directory as well as a slowdown in the addition of new ones. To counteract this trend, this work aimed to identify key success factors for digital health applications (DiGAs). Methods: This research identifies critical success factors through a structured literature review for developing sustainable digital health applications within the European healthcare systems, specifically DiGAs. The study aims to support the ongoing digital transformation in healthcare. Results: The identified success factors that significantly impact the sustainability of DiGAs include patient-centered design, application effectiveness, user-friendliness, and adherence to data protection and information security regulations using standardized approaches. These factors are crucial in preventing the failure of DiGA manufacturers in European countries. Conclusion: By considering and implementing these critical success factors, DiGA manufacturers can enhance their chances of long-term success and contribute to the digital transformation of the healthcare system in Europe.

ChatGPT-3.5 System Usability Scale early assessment among Healthcare Workers: Horizons of adoption in medical practice.

Artificial intelligence (AI) chatbots, such as ChatGPT, have widely invaded all domains of human life. They have the potential to transform healthcare future. However, their effective implementation hinges on healthcare workers' (HCWs) adoption and perceptions. This study aimed to evaluate HCWs usability of ChatGPT three months post-launch in Saudi Arabia using the System Usability Scale (SUS). A total of 194 HCWs participated in the survey. Forty-seven percent were satisfied with their usage, 57 % expressed moderate to high trust in its ability to generate medical decisions. 58 % expected ChatGPT would improve patients' outcomes, even though 84 % were optimistic of its potential to improve the future of healthcare practice. They expressed possible concerns like recommending harmful medical decisions and medicolegal implications. The overall mean SUS score was 64.52, equivalent to 50 % percentile rank, indicating high marginal acceptability of the system. The strongest positive predictors of high SUS scores were participants' belief in AI chatbot's benefits in medical research, self-rated familiarity with ChatGPT and self-rated computer skills proficiency. Participants' learnability and ease of use score correlated positively but weakly. On the other hand, medical students and interns had significantly high learnability scores compared to others, while ease of use scores correlated very strongly with participants' perception of positive impact of ChatGPT on the future of healthcare practice. Our findings highlight the HCWs' perceived marginal acceptance of ChatGPT at the current stage and their optimism of its potential in supporting them in future practice, especially in the research domain, in addition to humble ambition of its potential to improve patients' outcomes particularly in regard of medical decisions. On the other end, it underscores the need for ongoing efforts to build trust and address ethical and legal concerns of AI implications in healthcare. The study contributes to the growing body of literature on AI chatbots in healthcare, especially addressing its future improvement strategies and provides insights for policymakers and healthcare providers about the potential benefits and challenges of implementing them in their practice.

Digital health and health equity: How digital health can address healthcare disparities and improve access to quality care in Africa.

The healthcare industry is constantly evolving to bridge the inequality gap and provide precision care to its diverse population. One of these approaches is the integration of digital health tools into healthcare delivery. Significant milestones such as reduced maternal mortality, rising and rapidly proliferating health tech start-ups, and the use of drones and smart devices for remote health service delivery, among others, have been reported. However, limited access to family planning, migration of health professionals, climate change, gender inequity, increased urbanization, and poor integration of private health firms into healthcare delivery rubrics continue to impair the attainment of universal health coverage and health equity. Health policy development for an integrated health system without stigma, addressing inequalities of all forms, should be implemented. Telehealth promotion, increased access to infrastructure, international collaborations, and investment in health interventions should be continuously advocated to upscale the current health landscape and achieve health equity.

Individuals' attitudes toward digital mental health apps and implications for adoption in Portugal: web-based survey.

BACKGROUND: The literature is consensual regarding the academic community exhibiting higher levels of mental disorder prevalence than the general population. The potential of digital mental health apps for improving access to resources to cope with these issues is ample. However, studies have yet to be performed in Portugal on individuals' attitudes and perceptions toward digital mental health applications or their preferences and decision drivers on obtaining mental health care, self-assessment, or treatment. OBJECTIVE: This study aims to understand the determinants of digital mental health applications use in the Portuguese academic community of Porto, along with potential adoption barriers and enablers. METHODS: A cross-sectional, web-based survey was delivered via dynamic email to the University of Porto's academic community. Data collection occurred between September 20 and October 20, 2022. We used structural equation modeling to build three models, replicating a peer-reviewed and published study and producing a newly full mediation model shaped by the collected data. We tested the relationships between use of digital mental health apps and perceived stress, perceived need to seek help for mental health, perceived stigma, past use of mental health services, privacy concerns, and social influence. RESULTS: Of the 539 participants, 169 (31.4%) reported having used digital mental health apps. Perceived stress and a latent variable, comprising perceptions of mental health problems and coping strategies, were positively associated with mental health app use, while privacy concerns regarding one's information being accessible to others were negatively associated. Perceived stigma, need to seek help, and close relationships did not have a statistically significant direct effect. CONCLUSIONS: These findings can inform product and policy development of new, better-targeted digital mental health app interventions, with implications for researchers and academia, industry, and policymakers. Our study concludes that, to maximize adherence to these apps, they should have low to no financial charges, demonstrate evidence of their helpfulness and focus on the timely delivery of care. We also conclude that to foster digital mental health app use, there is a need to improve mental health literacy, namely regarding self-awareness of one's conditions, acceptable stress levels, and overall behavior towards mental health. TRIAL REGISTRATION: RR2-10.2196/41040.

A Technological Tool Aimed at Self-Care in Patients With Multimorbidity: Cross-Sectional Usability Study.

BACKGROUND: Information and communication technologies (ICTs) have been positioned as useful tools to facilitate self-care. The interaction between a patient and technology, known as usability, is particularly important for achieving positive health outcomes. Specific characteristics of patients with chronic diseases, including multimorbidity, can affect their interaction with different technologies. Thus, studying the usability of ICTs in the field of multimorbidity has become a key element to ensure their relevant role in promoting self-care. OBJECTIVE: The aim of this study was to analyze the usability of a technological tool dedicated to health and self-care in patients with multimorbidity in primary care. METHODS: A descriptive observational cross-sectional usability study was performed framed in the clinical trial in the primary care health centers of Madrid Health Service of the TeNDER (Affective Based Integrated Care for Better Quality of Life) project. The TeNDER technological tool integrates sensors for monitoring physical and sleep activity along with a mobile app for consulting the data collected and working with self-management tools. This project included patients over 60 years of age who had one or more chronic diseases, at least one of which was mild-moderate cognitive impairment, Parkinson disease, or cardiovascular disease. From the 250 patients included in the project, 38 agreed to participate in the usability study. The usability variables investigated were effectiveness, which was determined by the degree of completion and the total number of errors per task; efficiency, evaluated as the average time to perform each task; and satisfaction, quantified by the System Usability Scale. Five tasks were evaluated based on real case scenarios. Usability variables were analyzed according to the sociodemographic and clinical characteristics of patients. A logistic regression model was constructed to estimate the factors associated with the type of support provided for task completion. RESULTS: The median age of the 38 participants was 75 (IQR 72.0-79.0) years. There was a slight majority of women (20/38, 52.6%) and the participants had a median of 8 (IQR 7.0-11.0) chronic diseases. Thirty patients completed the usability study, with a usability effectiveness result of 89.3% (134/150 tasks completed). Among the 30 patients, 66.7% (n=20) completed all tasks and 56.7% (17/30) required personalized help on at least one task. In the multivariate analysis, educational level emerged as a facilitating factor for independent task completion (odds ratio 1.79, 95% CI 0.47-6.83). The median time to complete the total tasks was 296 seconds (IQR 210.0-397.0) and the median satisfaction score was 55 (IQR 45.0-62.5) out of 100. CONCLUSIONS: Although usability effectiveness was high, the poor efficiency and usability satisfaction scores suggest that there are other factors that may interfere with the results. Multimorbidity was not confirmed to be a key factor affecting the usability of the technological tool. TRIAL REGISTRATION: Clinicaltrials.gov NCT05681065; https://clinicaltrials.gov/study/NCT05681065.

Evaluating a Remotely Delivered Cardio-Oncology Rehabilitation Intervention for Patients With Breast Cancer (REMOTE-COR-B): Protocol for a Single-Arm Feasibility Trial.

BACKGROUND: Exercise rehabilitation is a promising strategy for reducing cardiovascular disease risk among patients with breast cancer. However, the evidence is primarily derived from programs based at exercise centers with in-person supervised delivery. Conversely, most patients report a preference for home-based rehabilitation. As such, there is a clear need to explore strategies that can provide real-time supervision and coaching while addressing consumer preferences. Evidence from cardiac rehabilitation has demonstrated the noninferiority of a smartphone-based telerehabilitation approach (REMOTE-CR) to improve cardiorespiratory fitness in people with cardiovascular disease compared to a center-based program. OBJECTIVE: This study aims to assess the feasibility, safety, and preliminary efficacy of the REMOTE-CR program adapted for patients with breast cancer at risk of cardiotoxicity (REMOTE-COR-B). We will also assess the satisfaction and usability of REMOTE-COR-B. METHODS: We will conduct a single-arm feasibility study of the REMOTE-COR-B program among patients with stage I-III breast cancer who are at risk of cardiotoxicity (taking treatment type and dose, as well as other common cardiovascular disease risk factors into account) and who are within 24 months of completing primary definitive treatment. Participants (target sample size of 40) will receive an 8-week smartphone-based telerehabilitation exercise program involving remotely delivered real-time supervision and behavior change support. The platform comprises a smartphone and wearable heart rate monitor, as well as a custom-built smartphone app and web application. Participants will be able to attend remotely monitored exercise sessions during set operating hours each week, scheduled in both the morning and evening. Adherence is the primary outcome of the trial, assessed through the number of remotely monitored exercise sessions attended compared to the trial target (ie, 3 sessions per week). Secondary outcomes include additional trial feasibility indicators (eg, recruitment and retention), safety, satisfaction, and usability, and objective and patient-reported efficacy outcomes (cardiovascular fitness, quality of life, fatigue, self-reported exercise, self-efficacy, habit strength, and motivation). Adherence, feasibility, and safety outcomes will be assessed during the intervention period; intervention satisfaction and usability will be assessed post intervention; and objective and patient-reported efficacy outcomes will be assessed at baseline, post intervention (2-month postbaseline assessment), and at follow-up (5-month postbaseline assessment). RESULTS: Recruitment for this trial commenced in March 2023, and 7 participants had been recruited as of the submission of the manuscript. The estimated completion date for the project is October 2024, with results expected to be published in mid-2025. CONCLUSIONS: The REMOTE-COR-B intervention is a novel and promising approach to providing exercise therapy to patients with breast cancer at risk of cardiotoxicity who have unique needs and heightened safety risks. This project will provide important information on the extent to which this approach is satisfactory to patients with breast cancer, safe, and potentially effective, which is necessary before larger-scale research or clinical projects. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12621001557820; www.anzctr.org.au/ACTRN12621001557820.aspx. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53301.

Development of a Health Behavioral Digital Intervention for Patients With Hypertension Based on an Intelligent Health Promotion System and WeChat: Randomized Controlled Trial.

BACKGROUND: The effectiveness of timely medication, physical activity (PA), a healthy diet, and blood pressure (BP) monitoring for promoting health outcomes and behavioral changes among patients with hypertension is supported by a substantial amount of literature, with "adherence" playing a pivotal role. Nevertheless, there is a lack of consistent evidence regarding whether digital interventions can improve adherence to healthy behaviors among individuals with hypertension. OBJECTIVE: The aim was to develop a health behavioral digital intervention for hypertensive patients (HBDIHP) based on an intelligent health promotion system and WeChat following the behavior change wheel (BCW) theory and digital micro-intervention care (DMIC) model and assess its efficacy in controlling BP and improving healthy behavior adherence. METHODS: A 2-arm, randomized trial design was used. We randomly assigned 68 individuals aged >60 years with hypertension in a 1:1 ratio to either the control or experimental group. The digital intervention was established through the following steps: (1) developing digital health education materials focused on adherence to exercise prescriptions, Dietary Approaches to Stop Hypertension (DASH), prescribed medication, and monitoring of BP; (2) using the BCW theory to select behavior change techniques; (3) constructing the intervention's logic following the guidelines of the DMIC model; (4) creating an intervention manual including the aforementioned elements. Prior to the experiment, participants underwent physical examinations at the community health service center's intelligent health cabin and received intelligent personalized health recommendations. The experimental group underwent a 12-week behavior intervention via WeChat, while the control group received routine health education and a self-management manual. The primary outcomes included BP and adherence indicators. Data analysis was performed using SPSS, with independent sample t tests, chi-square tests, paired t tests, and McNemar tests. A P value <.05 was considered statistically significant. RESULTS: The final analysis included 54 participants with a mean age of 67.24 (SD 4.19) years (n=23 experimental group, n=31 control group). The experimental group had improvements in systolic BP (-7.36 mm Hg, P=.002), exercise time (856.35 metabolic equivalent [MET]-min/week, P<.001), medication adherence (0.56, P=.001), BP monitoring frequency (P=.02), and learning performance (3.23, P<.001). Both groups experienced weight reduction (experimental: 1.2 kg, P=.002; control: 1.11 kg, P=.009) after the intervention. The diet types and quantities for both groups (P<.001) as well as the subendocardial viability ratio (0.16, P=.01) showed significant improvement. However, there were no statistically significant changes in other health outcomes. CONCLUSIONS: The observations suggest our program may have enhanced specific health outcomes and adherence to health behaviors in older adults with hypertension. However, a longer-term, larger-scale trial is necessary to validate the effectiveness. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2200062643; https://www.chictr.org.cn/showprojEN.html?proj=172782. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/46883.

Acceptability of a Self-Guided Lifestyle Intervention Among Young Men: Mixed Methods Analysis of Pilot Findings.

BACKGROUND: Young men are vastly underrepresented in lifestyle interventions, suggesting a need to develop appealing yet effective interventions for this population. OBJECTIVE: This study aimed to determine the acceptability of a self-guided lifestyle intervention designed specifically for young men (age: 18-35 years old). METHODS: Semistructured interviews and surveys were completed by 14 men following completion of a remotely delivered, 12-week lifestyle intervention. The intervention included 1 virtual group session, digital tools, access to self-paced web- and mobile-based content, and 12 weekly health risk text messages. We quantitatively and qualitatively examined young men's experiences with the intervention components of a remotely delivered, self-guided lifestyle intervention targeting weight loss. Data were integrated using convergent mixed methods analysis. RESULTS: Men were a mean age of 29.9 (SD 4.9) years with a mean BMI of 31.0 (SD 4.5) kg/m2. The self-guided aspect was not acceptable, and a majority preferred more check-ins. Participants expressed a desire for a social aspect in future lifestyle interventions. All men found the focus on health risks appealing. A majority of men found the study-issued, Bluetooth-enabled scale acceptable. CONCLUSIONS: Acceptability of the self-guided lifestyle intervention was perceived as suboptimal by young men. The findings highlight the need to add intervention components that sustain motivation and provide additional social support for young men. TRIAL REGISTRATION: ClinicalTrials.gov NCT04267263; https://www.clinicaltrials.gov/study/NCT04267263.

Nudges and Prompts Increase Engagement in Self-Guided Digital Health Treatment for Depression and Anxiety: Results From a 3-Arm Randomized Controlled Trial.

BACKGROUND: Accessible and effective approaches to mental health treatment are important because of common barriers such as cost, stigma, and provider shortage. The effectiveness of self-guided treatment is well established, and its use has intensified because of the COVID-19 pandemic. Engagement remains important as dose-response relationships have been observed. Platforms such as Facebook (Meta Platform, Inc), LinkedIn (Microsoft Corp), and X Corp (formerly known as Twitter, Inc) use principles of behavioral economics to increase engagement. We hypothesized that similar concepts would increase engagement in self-guided digital health. OBJECTIVE: This 3-arm randomized controlled trial aimed to test whether members of 2 digital self-health courses for anxiety and depression would engage with behavioral nudges and prompts. Our primary hypothesis was that members would click on 2 features: tips and a to-do checklist. Our secondary hypothesis was that members would prefer to engage with directive tips in arm 2 versus social proof and present bias tips in arm 3. Our tertiary hypothesis was that rotating tips and a to-do checklist would increase completion rates. The results of this study will form a baseline for future artificial intelligence-directed research. METHODS: Overall, 13,224 new members registered between November 2021 and May 2022 for Evolution Health's self-guided treatment courses for anxiety and depression. The control arm featured a member home page without nudges or prompts. Arm 2 featured a home page with a tip-of-the-day section. Arm 3 featured a home page with a tip-of-the-day section and a to-do checklist. The research protocol for this study was published in JMIR Research Protocols on August 15, 2022. RESULTS: Arm 3 had significantly younger members (F2,4564=40.97; P<.001) and significantly more female members (χ24=92.2; P<.001) than the other 2 arms. Control arm members (1788/13,224, 13.52%) completed an average of 1.5 course components. Arm 2 members (865/13,224, 6.54%) clicked on 5% of tips and completed an average of 1.8 course components. Arm 3 members (1914/13,224, 14.47%) clicked on 5% of tips, completed 2.7 of 8 to-do checklist items, and completed an average of 2.11 course components. Completion rates in arm 2 were greater than those in arm 1 (z score=3.37; P<.001), and completion rates in arm 3 were greater than those in arm 1 (z score=12.23; P<.001). Engagement in all 8 components in arm 3 was higher than that in arm 2 (z score=1.31; P<.001). CONCLUSIONS: Members engaged with behavioral nudges and prompts. The results of this study may be important because efficacy is related to increased engagement. Due to its novel approach, the outcomes of this study should be interpreted with caution and used as a guideline for future research in this nascent field. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/37231.

Evaluation of the e-Mental Health Intervention Make It Training From Patients' Perspectives: Qualitative Analysis Within the Reduct Trial.

BACKGROUND: Make It Training is an e-mental health intervention designed for individuals with cancer that aims to reduce psychological distress and improve disease-related coping and quality of life. OBJECTIVE: This study evaluated the experienced usefulness and usability of the web-based Make It Training intervention using a qualitative approach. METHODS: In this study, semistructured interviews were conducted with participants at different cancer stages and with different cancer entities. All participants had previously taken part in the Reduct trial, a randomized controlled trial that assessed the efficacy of the Make It Training intervention. The data were coded deductively by 2 independent researchers and analyzed iteratively using thematic codebook analysis. RESULTS: Analysis of experienced usefulness resulted in 4 themes (developing coping strategies to reduce psychological distress, improvement in quality of life, Make It Training vs traditional psychotherapy, and integration into daily life) with 11 subthemes. Analysis of experienced usability resulted in 3 themes (efficiency and accessibility, user-friendliness, and recommendations to design the Make It Training intervention to be more appealing) with 6 subthemes. Make It Training was evaluated as a user-friendly intervention helpful for developing functional coping strategies to reduce psychological distress and improve quality of life. The consensus regarding Make It Training was that it was described as a daily companion that integrates well into daily life and that it has the potential to be routinely implemented within oncological health care either as a stand-alone intervention or in addition to psychotherapy. CONCLUSIONS: e-Mental health interventions such as Make It Training can target both the prevention of mental health issues and health promotion. Moreover, they offer a cost-efficient and low-threshold option to receive psycho-oncological support.

Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone App-Led Cognitive Behavioral Therapy for Depression Under Therapist Supervision: Open Trial.

BACKGROUND: Major depressive disorder affects approximately 1 in 5 adults during their lifetime and is the leading cause of disability worldwide. Yet, a minority receive adequate treatment due to person-level (eg, geographical distance to providers) and systems-level (eg, shortage of trained providers) barriers. Digital tools could improve this treatment gap by reducing the time and frequency of therapy sessions needed for effective treatment through the provision of flexible, automated support. OBJECTIVE: This study aimed to examine the feasibility, acceptability, and preliminary clinical effect of Mindset for Depression, a deployment-ready 8-week smartphone-based cognitive behavioral therapy (CBT) supported by brief teletherapy appointments with a therapist. METHODS: This 8-week, single-arm open trial tested the Mindset for Depression app when combined with 8 brief (16-25 minutes) video conferencing visits with a licensed doctoral-level CBT therapist (n=28 participants). The app offers flexible, accessible psychoeducation, CBT skills practice, and support to patients as well as clinician guidance to promote sustained engagement, monitor safety, and tailor treatment to individual patient needs. To increase accessibility and thus generalizability, all study procedures were conducted remotely. Feasibility and acceptability were assessed via attrition, patient expectations and feedback, and treatment utilization. The primary clinical outcome measure was the clinician-rated Hamilton Depression Rating Scale, administered at pretreatment, midpoint, and posttreatment. Secondary measures of functional impairment and quality of life as well as maintenance of gains (3-month follow-up) were also collected. RESULTS: Treatment credibility (week 4), expectancy (week 4), and satisfaction (week 8) were moderate to high, and attrition was low (n=2, 7%). Participants self-reported using the app or practicing (either on or off the app) the CBT skills taught in the app for a median of 50 (IQR 30-60; week 4) or 60 (IQR 30-90; week 8) minutes per week; participants accessed the app on an average 36.8 (SD 10.0) days and completed a median of 7 of 8 (IQR 6-8) steps by the week 8 assessment. The app was rated positively across domains of engagement, functionality, aesthetics, and information. Participants' depression severity scores decreased from an average Hamilton Depression Rating Scale score indicating moderate depression (mean 19.1, SD 5.0) at baseline to a week 8 mean score indicating mild depression (mean 10.8, SD 6.1; d=1.47; P<.001). Improvement was also observed for functional impairment and quality of life. Gains were maintained at 3-month follow-up. CONCLUSIONS: The results show that Mindset for Depression is a feasible and acceptable treatment option for individuals with major depressive disorder. This smartphone-led treatment holds promise to be an efficacious, scalable, and cost-effective treatment option. The next steps include testing Mindset for Depression in a fully powered randomized controlled trial and real-world clinical settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT05386329; https://clinicaltrials.gov/study/NCT05386329?term=NCT05386329.

Converge or Collide? Making Sense of a Plethora of Open Data Standards in Health Care.

Practitioners of digital health are familiar with disjointed data environments that often inhibit effective communication among different elements of the ecosystem. This fragmentation leads in turn to issues such as inconsistencies in services versus payments, wastage, and notably, care delivered being less than best-practice. Despite the long-standing recognition of interoperable data as a potential solution, efforts in achieving interoperability have been disjointed and inconsistent, resulting in numerous incompatible standards, despite the widespread agreement that fewer standards would enhance interoperability. This paper introduces a framework for understanding health care data needs, discussing the challenges and opportunities of open data standards in the field. It emphasizes the necessity of acknowledging diverse data standards, each catering to specific viewpoints and needs, while proposing a categorization of health care data into three domains, each with its distinct characteristics and challenges, along with outlining overarching design requirements applicable to all domains and specific requirements unique to each domain.