Digital mental health interventions are routinely integrated into mental health services internationally and can contribute to reducing the global mental health treatment gap identified by the World Health Organization. Research teams designing and delivering evaluations frequently invest substantial effort in deliberating on ethical and legal challenges around digital mental health interventions. In this article, we reflect on our own research experience with digital mental health intervention design and evaluation to identify 8 of the most critical challenges that we or others have faced, and that have ethical or legal consequences. These include: (1) harm caused by online recruitment work; (2) monitoring of intervention safety; (3) exclusion of specific demographic or clinical groups; (4) inadequate robustness of effectiveness and cost-effectiveness findings; (5) adequately conceptualizing and supporting engagement and adherence; (6) structural barriers to implementation; (7) data protection and intellectual property; and (8) regulatory ambiguity relating to digital mental health interventions that are medical devices. As we describe these challenges, we have highlighted serious consequences that can or have occurred, such as substantial delays to studies if regulations around Software as a Medical Device (SaMD) are not fully understood, or if regulations change substantially during the study lifecycle. Collectively, the challenges we have identified highlight a substantial body of required knowledge and expertise, either within the team or through access to external experts. Ensuring access to knowledge requires careful planning and adequate financial resources (for example, paying public contributors to engage in debate on critical ethical issues or paying for legal opinions on regulatory issues). Access to such resources can be planned for on a per-study basis and enabled through funding proposals. However, organizations regularly engaged in the development and evaluation of digital mental health interventions should consider creating or supporting structures such as advisory groups that can retain necessary competencies, such as in medical device regulation.

The majority of Black women with hypertension in the United States have smartphones or tablets and use social media, and many use wearable activity trackers and health or wellness apps, digital tools that can be used to support lifestyle changes and medication adherence.

BACKGROUND: Exercise therapy is recommended by international guidelines as a core treatment for patients with knee osteoarthritis. However, there is a significant gap between recommendations and practice in health care. Digital exercise apps are promising to help solve this undersupply.
OBJECTIVE: This study aims to evaluate the efficacy of a 12-week fully automated app-based exercise intervention with and without a supporting knee brace on health-related outcomes, performance measures, and adherence in patients with knee osteoarthritis.
METHODS: This closed user group trial included participants with moderate to severe unicondylar painful knee osteoarthritis. Randomization was 1:1:2 into an intervention group (IG) with 2 subgroups (app-based training [IG A] and app-based training and a supportive knee brace [IG AB]) and a control group (CG). The intervention included a 12-week home exercise program with 3 sessions per week. Instructions for the exercises were given via the app and monitored using 2 accelerometers placed below and above the affected knee joint. Participants in the CG did not receive any study intervention but were allowed to make use of usual care. Osteoarthritis-specific pain (Knee Injury and Osteoarthritis Outcome Score) was defined as the primary outcome, and secondary outcomes included all other Knee Injury and Osteoarthritis Outcome Score subscales, general health-related quality of life (Veterans RAND 12-item Health Survey), psychological measures (eg, exercise self-efficacy), performance measures (strength and postural control), and the monitoring of adherence and safety. Outcomes were assessed at baseline and after 12 weeks. Intervention effects were calculated using baseline-adjusted analysis of covariance for the joint comparison of IG A and IG AB versus the CG using a per-protocol approach. Subgroup analyses were conducted for each IG separately.
RESULTS: A total of 61 participants were included (IG: n=30, 49%; CG: n=31, 51%; male: n=31, 51%; female: n=30, 49%; mean age 62.9, SD 8.5 years; mean BMI 27.7, SD 4.5 kg/m2). Analysis revealed statistically significant effects in favor of the IG for pain reduction (P<.001; effect size [ES]=0.76), improvements in physical function (P<.001; ES=0.64), improvements in symptoms (P=.01; ES=0.53), improvements in sport and recreation activities (P=.02; ES=0.47), improvements in knee-related quality of life (P<.001; ES=0.76), and improvements in the physical component of general health-related quality of life (P<.001; ES=0.74). Mean differences ranged from 6.0 to 13.2 points (scale range 0-100). ESs indicated small to medium effects. No effects were found for psychological and performance measures. Participants adhered to 92.5% (899/972) of all scheduled exercise sessions.
CONCLUSIONS: Individuals with knee osteoarthritis undergoing a 12-week sensor-assisted app-based exercise intervention with or without an additional knee brace experienced clinically meaningful treatment effects regarding pain relief and improvements in physical function as well as other osteoarthritis-specific concerns compared to controls.
BACKGROUND: German Clinical Trials Register (DRKS) DRKS00023269; https://drks.de/search/de/trial/DRKS00023269.

BACKGROUND: Children with disabilities face numerous challenges in accessing health services. Mobile health is an emerging field that could significantly reduce health inequities by providing more accessible services. Many mobile apps incorporate gamification elements such as feedback, points, and stories to increase engagement and motivation; however, little is known about how gamification has been incorporated in mobile apps for children with disabilities.
OBJECTIVE: This scoping review aims to identify and synthesize the existing research evidence on the use of gamification in mobile apps for children with disabilities. Specifically, the objectives were to (1) identify the categories of these mobile apps (eg, treatment and educational) (2), describe the health-related outcomes they target, (3) assess the types and levels of gamification elements used within these apps, and (4) determine the reasons for incorporating gamification elements into mobile apps.
METHODS: We searched MEDLINE, PsycINFO, CINAHL, Embase, the ACM Digital Library, and IEEE Xplore databases to identify papers published between 2008 and 2023. Original empirical research studies reporting on gamified mobile apps for children with disabilities that implemented at least 1 gamification strategy or tactic were included. Studies investigating serious games or full-fledged games were excluded.
RESULTS: A total of 38 studies reporting on 32 unique gamified mobile apps were included. Findings showed that gamified apps focus on communication skills and oral health in children with autism spectrum disorder while also addressing self-management and academic skills for other disability groups. Gamified mobile apps have demonstrated potential benefits across different populations and conditions; however, there were mixed results regarding their impact. The gamification strategies included fun and playfulness (23/32, 72%), feedback on performance (17/32, 53%), and reinforcement (17/32, 53%) in more than half of apps, whereas social connectivity was used as a gamification strategy in only 4 (12%) mobile apps. There were 2 main reasons for integrating gamification elements into mobile apps described in 16 (42%) studies: increasing user engagement and motivation and enhancing intervention effects.
CONCLUSIONS: This scoping review offers researchers a comprehensive review of the gamification elements currently used in mobile apps for the purposes of treatment, education, symptom management, and assessment for children with disabilities. In addition, it indicates that studies on certain disability groups and examinations of health-related outcomes have been neglected, highlighting the need for further investigations in these areas. Furthermore, research is needed to investigate the effectiveness of mobile-based gamification elements on health and health behavior outcomes, as well as the healthy development of children with disabilities.

BACKGROUND: Survivorship care plans (SCPs) are provided at the completion of cancer treatment to aid in the transition from active treatment to long-term survivorship. They describe the details of a patient\'s diagnosis and treatment and offer recommendations for follow-up appointments, referrals, and healthy behaviors. The plans are currently paper-based and become outdated as soon as a patient\'s health status changes. There is a need to digitize these plans to improve their accessibility, modifiability, and longevity. With current technology, SCPs can be linked to mobile devices and activity trackers so that patients can track health behaviors and compare them to their clinical goals, taking charge of their own health.
OBJECTIVE: A mobile app, POSTHOC (POST-Treatment Health Outcomes of Cancer Survivors), that digitizes the SCP was developed, with goals of integrating it with wearable technologies and electronic medical records. Herein, we are conducting a randomized controlled trial that evaluates the POSTHOC app versus the traditional SCP on total symptom burden in the early posttreatment period.
METHODS: We will recruit 54 patients who have recently completed curative therapy for cancer (any type) in person and remotely. They will be randomized 2:1, POSTHOC:usual care (unblinded). Those randomized to the POSTHOC group will receive their SCP via the app and will choose to focus on nutrition or exercise for the duration of the study based on their individual plan and personal preferences. Those randomized to the control group will get a paper-based plan. At baseline, 6 weeks, and 12 weeks, we will evaluate patient-reported outcomes, including total symptom burden (web-based questionnaire), diet (24-hour Automated Self-Administered [ASA24]), and physical activity (Fitbit Charge 6 [Google LLC]). We will also collect quantitative and qualitative feedback on the usability of the app from those in the POSTHOC arm to improve the app for future implementation studies, with a specific focus on patient-provider communication. For feasibility, we will calculate the percentage of patients who used the POSTHOC app at least 3 times per week. We will use linear mixed models to evaluate the effects of the POSTHOC app versus those of usual care on other outcomes at weeks 6 and 12.
RESULTS: This trial is open to accrual in the University of Maryland Medical System as of March 2024, and as of July 3, 2024, a total of 20 participants have consented.
CONCLUSIONS: This study is among the first to digitize the SCP in a mobile app and test the effects of a mobile health-delivered behavioral health intervention on symptom burden in cancer survivors. Our results will provide evidence about the effects of health self-management on symptoms. This knowledge will be integral to larger randomized controlled studies, integration with the electronic medical record, and nationwide implementation.
BACKGROUND: ClinicalTrials.gov NCT05499663; https://clinicaltrials.gov/ct2/show/NCT05499663.
UNASSIGNED: DERR1-10.2196/59222.

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UNASSIGNED: Controlling saturated fat and cholesterol intake is important for the prevention of cardiovascular diseases. Although the use of mobile diet-tracking apps has been increasing, the reliability of nutrition apps in tracking saturated fats and cholesterol across different nations remains underexplored.
UNASSIGNED: This study aimed to examine the reliability and consistency of nutrition apps focusing on saturated fat and cholesterol intake across different national contexts. The study focused on 3 key concerns: data omission, inconsistency (variability) of saturated fat and cholesterol values within an app, and the reliability of commercial apps across different national contexts.
UNASSIGNED: Nutrient data from 4 consumer-grade apps (COFIT, MyFitnessPal-Chinese, MyFitnessPal-English, and LoseIt!) and an academic app (Formosa FoodApp) were compared against 2 national reference databases (US Department of Agriculture [USDA]-Food and Nutrient Database for Dietary Studies [FNDDS] and Taiwan Food Composition Database [FCD]). Percentages of missing nutrients were recorded, and coefficients of variation were used to compute data inconsistencies. One-way ANOVAs were used to examine differences among apps, and paired 2-tailed t tests were used to compare the apps to national reference data. The reliability across different national contexts was investigated by comparing the Chinese and English versions of MyFitnessPal with the USDA-FNDDS and Taiwan FCD.
UNASSIGNED: Across the 5 apps, 836 food codes from 42 items were analyzed. Four apps, including COFIT, MyFitnessPal-Chinese, MyFitnessPal-English, and LoseIt!, significantly underestimated saturated fats, with errors ranging from -13.8% to -40.3% (all P<.05). All apps underestimated cholesterol, with errors ranging from -26.3% to -60.3% (all P<.05). COFIT omitted 47% of saturated fat data, and MyFitnessPal-Chinese missed 62% of cholesterol data. The coefficients of variation of beef, chicken, and seafood ranged from 78% to 145%, from 74% to 112%, and from 97% to 124% across MyFitnessPal-Chinese, MyFitnessPal-English, and LoseIt!, respectively, indicating a high variability in saturated fats across different food groups. Similarly, cholesterol variability was consistently high in dairy (71%-118%) and prepackaged foods (84%-118%) across all selected apps. When examining the reliability of MyFitnessPal across different national contexts, errors in MyFitnessPal were consistent across different national FCDs (USDA-FNDSS and Taiwan FCD). Regardless of the FCDs used as a reference, these errors persisted to be statistically significant, indicating that the app\'s core database is the source of the problems rather than just mismatches or variances in external FCDs.
UNASSIGNED: The findings reveal substantial inaccuracies and inconsistencies in diet-tracking apps\' reporting of saturated fats and cholesterol. These issues raise concerns for the effectiveness of using consumer-grade nutrition apps in cardiovascular disease prevention across different national contexts and within the apps themselves.

Purpose. Caring Text Messages (CTM) is an evidence-based intervention, developed by the Northwest Portland Area Indian Health Board, modeled after the Caring Contacts (CC) intervention. CC has been shown to prevent suicide deaths, attempts, ideation, and hospitalizations in a variety of settings. Method. Three sets of CTM were developed by American Indian and Alaska Native (AI/AN) teens, college students, and veterans (tailored for each audience), which were reviewed by psychologists familiar with the intervention. To enroll in the service, participants texted a keyword to a text message short code and received two text messages per week with hopeful and encouraging messages. A robust multimedia social marketing campaign was designed to promote the service for each audience. Results. By September 2023, 387 participants enrolled in the Youth CTM intervention, 141 enrolled in the College CTM, and 31 enrolled in the Veterans CTM. Post surveys show elevated levels of user satisfaction. Conclusions. CTM can be tailored to reach populations at higher risk of suicide, including AI/AN youth, college students, and veterans, and connect them to culturally responsive peer and crisis support services. Continued monitoring and evaluation can guide next steps for marketing and outreach and will be useful to determine its impact on those who enroll.

BACKGROUND: Wearable digital health technologies and mobile apps (personal digital health technologies [DHTs]) hold great promise for transforming health research and care. However, engagement in personal DHT research is poor.
OBJECTIVE: The objective of this paper is to describe how participant engagement techniques and different study designs affect participant adherence, retention, and overall engagement in research involving personal DHTs.
METHODS: Quantitative and qualitative analysis of engagement factors are reported across 6 unique personal DHT research studies that adopted aspects of a participant-centric design. Study populations included (1) frontline health care workers; (2) a conception, pregnant, and postpartum population; (3) individuals with Crohn disease; (4) individuals with pancreatic cancer; (5) individuals with central nervous system tumors; and (6) families with a Li-Fraumeni syndrome affected member. All included studies involved the use of a study smartphone app that collected both daily and intermittent passive and active tasks, as well as using multiple wearable devices including smartwatches, smart rings, and smart scales. All studies included a variety of participant-centric engagement strategies centered on working with participants as co-designers and regular check-in phone calls to provide support over study participation. Overall retention, probability of staying in the study, and median adherence to study activities are reported.
RESULTS: The median proportion of participants retained in the study across the 6 studies was 77.2% (IQR 72.6%-88%). The probability of staying in the study stayed above 80% for all studies during the first month of study participation and stayed above 50% for the entire active study period across all studies. Median adherence to study activities varied by study population. Severely ill cancer populations and postpartum mothers showed the lowest adherence to personal DHT research tasks, largely the result of physical, mental, and situational barriers. Except for the cancer and postpartum populations, median adherences for the Oura smart ring, Garmin, and Apple smartwatches were over 80% and 90%, respectively. Median adherence to the scheduled check-in calls was high across all but one cohort (50%, IQR 20%-75%: low-engagement cohort). Median adherence to study-related activities in this low-engagement cohort was lower than in all other included studies.
CONCLUSIONS: Participant-centric engagement strategies aid in participant retention and maintain good adherence in some populations. Primary barriers to engagement were participant burden (task fatigue and inconvenience), physical, mental, and situational barriers (unable to complete tasks), and low perceived benefit (lack of understanding of the value of personal DHTs). More population-specific tailoring of personal DHT designs is needed so that these new tools can be perceived as personally valuable to the end user.

BACKGROUND: Hypertension management apps (HMAs) can be effective in controlling blood pressure, but their actual impact is often suboptimal. Establishing a user satisfaction evaluation indicator system for HMAs can assist app developers in enhancing app design and functionality, while also helping users identify apps that best meet their needs. This approach aims to improve the overall effectiveness of app usage.
OBJECTIVE: This study aims to systematically collect data on HMAs and their user reviews in the United States and China. It analyzes app usage patterns and functional characteristics, identifies factors influencing user satisfaction from existing research, and develops a satisfaction evaluation indicator system to provide more accurate recommendations for improving user satisfaction.
METHODS: We conducted a descriptive statistical analysis to assess the development status of HMAs in both countries and applied the task-technology fit model to evaluate whether the app functionalities align with business needs. We separately summarized the factors influencing user satisfaction in both countries from previous research, utilized the analytic hierarchy process to develop an evaluation indicator system for HMA user satisfaction, and calculated satisfaction levels. Based on these findings, we propose improvements to enhance app functionality and user satisfaction.
RESULTS: In terms of current development status, there were fewer HMAs and user reviews in China compared with the United States. Regarding app functional availability, fewer than 5% (4/91) of the apps achieved a demand fulfillment rate exceeding 80% (8/10). Overall, user satisfaction in both countries was low.
CONCLUSIONS: In the United States, user satisfaction was lowest for advertising distribution, data synchronization, and reliability. By contrast, Chinese apps need improvements in cost efficiency and compatibility.