Background: Meta-analyses of telemonitoring for patients with heart failure conclude that it can lower the utilization of health services and improve health outcomes compared with the standard of care. A smartphone-based telemonitoring program is being implemented as part of the standard of care at a specialty care clinic for patients with heart failure in Toronto, Canada. Objective: The objectives of this study are to (1) evaluate the impact of the telemonitoring program on health service utilization, patient health outcomes, and their ability to self-care; (2) identify the contextual barriers and facilitators of implementation at the physician, clinic, and institutional level; (3) describe patient usage patterns to determine adherence and other behaviors in the telemonitoring program; and (4) evaluate the costs associated with implementation of the telemonitoring program from the perspective of the health care system (ie, public payer), hospital, and patient. Methods: The evaluation will use a mixed-methods approach. The quantitative component will include a pragmatic pre- and posttest study design for the impact and cost analyses, which will make use of clinical data and questionnaires administered to at least 108 patients at baseline and 6 months. Furthermore, outcome data will be collected at 1, 12, and 24 months to explore the longitudinal impact of the program. In addition, quantitative data related to implementation outcomes and patient usage patterns of the telemonitoring system will be reported. The qualitative component involves an embedded single case study design to identify the contextual factors that influenced the implementation. The implementation evaluation will be completed using semistructured interviews with clinicians, and other program staff at baseline, 4 months, and 12 months after the program start date. Interviews conducted with patients will be triangulated with usage data to explain usage patterns and adherence to the system. Results: The telemonitoring program was launched in August 2016 and patient enrollment is ongoing. Conclusions: The methods described provide an example for conducting comprehensive evaluations of telemonitoring programs. The combination of impact, implementation, and cost evaluations will inform the quality improvement of the existing program and will yield insights into the sustainability of smartphone-based telemonitoring programs for patients with heart failure within a specialty care setting. International Registered Report Identifier (IRRID): RR1-10.2196/resprot.9911

Background: Skin cancer, the most common cancer in the United States, is costly and potentially deadly. Its burden can be reduced by early detection and prevention activities. The scope of skin cancer requires going beyond traditional health care providers to promote risk reduction. Partnering with the nonbiomedical workforce, such as massage therapists (MTs), may reach more individuals at risk. MTs see much of their clients’ skin and are amenable to performing skin cancer risk reduction activities during massage appointments. Objective: The objective of this study is to describe the Massage Therapists Skin Health Awareness, Referral, and Education protocol, presenting an overview of our systematic approach to developing rigorous e-training for MTs to enable them to be partners in skin cancer risk reduction. We also describe procedures for usability and feasibility testing of the training. Methods: We developed an integrated electronic learning system that includes electronic training (e-training) technology, simulated client interactions, online data collection instruments, and in-person assessment of MTs’ application of their training. Results: A total of 20 participants nationally scored the e-training as high for usability and satisfaction. We have screened an additional 77 MTs in Arizona for interest and eligibility, and currently have 37 enrolled participants, of whom 32 have completed the Web-based training. Conclusions: The structured and rigorous development approach for this skin cancer risk reduction and brief behavioral intervention e-training for MTs begins to fill a gap in skin cancer risk reduction research. Iterative usability testing of our asynchronous Web-based training resulted in positive participant response. Our e-training approach offers greater learner accessibility, increased convenience, and greater scalability than the few existing programs and has the potential to reach many MTs nationally. International Registered Report Identifier (IRRID): DERR1-10.2196/13480

Background: Assessment of pain is critical to its optimal treatment. There is a high demand for accurate objective pain assessment for effectively optimizing pain management interventions. However, pain is a multivalent, dynamic, and ambiguous phenomenon that is difficult to quantify, particularly when the patient’s ability to communicate is limited. The criterion standard of pain intensity assessment is self-reporting. However, this unidimensional model is disparaged for its oversimplification and limited applicability in several vulnerable patient populations. Researchers have attempted to develop objective pain assessment tools through analysis of physiological pain indicators, such as electrocardiography, electromyography, photoplethysmography, and electrodermal activity. However, pain assessment by using only these signals can be unreliable, as various other factors alter these vital signs and the adaptation of vital signs to pain stimulation varies from person to person. Objective pain assessment using behavioral signs such as facial expressions has recently gained attention. Objective: Our objective is to further the development and research of a pain assessment tool for use with patients who are likely experiencing mild to moderate pain. We will collect observational data through wearable technologies, measuring facial electromyography, electrocardiography, photoplethysmography, and electrodermal activity. Methods: This protocol focuses on the second phase of a larger study of multimodal signal acquisition through facial muscle electrical activity, cardiac electrical activity, and electrodermal activity as indicators of pain and for building predictive models. We used state-of-the-art standard sensors to measure bioelectrical electromyographic signals and changes in heart rate, respiratory rate, and oxygen saturation. Based on the results, we further developed the pain assessment tool and reconstituted it with modern wearable sensors, devices, and algorithms. In this second phase, we will test the smart pain assessment tool in communicative patients after elective surgery in the recovery room. Results: Our human research protections application for institutional review board review was approved for this part of the study. We expect to have the pain assessment tool developed and available for further research in early 2021. Preliminary results will be ready for publication during fall 2020. Conclusions: This study will help to further the development of and research on an objective pain assessment tool for monitoring patients likely experiencing mild to moderate pain.

Introduction: Millions of smokers use the Internet for smoking cessation assistance each year; however, most smokers engage minimally with even the best designed websites. The ubiquity of mobile devices and their effectiveness in promoting adherence in other areas of health behaviour change make them a promising tool to address adherence in Internet smoking cessation interventions. Text messaging is used by most adults, and messages can proactively encourage use of a web-based intervention. Text messaging can also be integrated with an Internet intervention to facilitate the use of core Internet intervention components. Methods and analysis: We identified four aspects of a text message intervention that may enhance its effectiveness in promoting adherence to a web-based smoking cessation programme: personalisation, integration, dynamic tailoring and message intensity. Phase I will use a two-level full factorial design to test the impact of these four experimental features on adherence to a web-based intervention. The primary outcome is a composite metric of adherence that incorporates general utilisation metrics (eg, logins, page views) and specific feature utilisation shown to predict abstinence. Participants will be N=860 adult smokers who register on an established Internet cessation programme and enrol in its text message programme. Phase II will be a two-arm randomised trial to compare the efficacy of the web-based cessation programme alone and in conjunction with the optimised text messaging intervention on 30-day point prevalence abstinence at 9 months. Phase II participants will be N=600 adult smokers who register to use an established Internet cessation programme and enrol in text messaging. Secondary analyses will explore whether adherence mediates the effect of treatment condition on outcome. Ethics and dissemination: This protocol was approved by Chesapeake IRB. We will disseminate study results through peer-reviewed manuscripts and conference presentations related to the methods and design, outcomes and exploratory analyses. Trial registration number: NCT02585206.

BACKGROUND: Online interventions are potentially effective ways to support family caregivers in the management of behavior changes in their relative with dementia. OBJECTIVE: The objective of this paper is to present the design of a study evaluating and comparing 3 intervention arms for online self-management support. METHODS: A randomized controlled trial (RCT) will be conducted with a total of 81 family caregivers of community-dwelling people with dementia in the Netherlands. Family caregivers will be randomly allocated to one of the following intervention arms: (1) a major self-management support intervention consisting of personal email contacts with a nurse specialized in dementia care, online videos, and electronic bulletins (e-bulletins); (2) a medium self-management support intervention consisting of only online videos and e-bulletins; and (3) a minor self-management support intervention with only e-bulletins. The primary outcome is the self-efficacy of the family caregiver. The secondary outcomes are the behavior problems of the person with dementia as reported by the family caregiver, and positive and negative aspects of the relationship. Background characteristics (eg, type of family relationship) will also be assessed. All data for the RCT will be collected via online questionnaires, administered before the intervention (T0), after 6 weeks (T1), and after 12 weeks (T2). Alongside the RCT, a process evaluation will be conducted, based on a number of evaluation questions and semi-open interviews with family caregivers. RESULTS: Data collection will be completed in August 2017. Study results will be reported in early 2018. CONCLUSIONS: The study will shed more light on the effect of online self-management support interventions and insights will be gained into whether a major intervention, consisting of personal email contacts with specialized nurses, videos, and e-bulletins, has more effect than smaller online interventions. This is relevant in an age with increasing numbers of people with dementia, growing pressure on family caregivers, more and more people using the Internet, and increasing healthcare costs. TRIAL REGISTRATION: Nederlands Trial Registry (NTR): NTR6237; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6237 (Archived by WebCite at http://www.webcitation.org/6v0S4fxTC).

Background: Massive open online courses (MOOCs) have increased in popularity in recent years. They target a wide variety of learners and use novel teaching approaches, yet often exhibit low completion rates (10%). It is important to evaluate MOOCs to determine their impact and effectiveness, but little is known at this point about the methodologies that should be used for evaluation. Objective: The purpose of this paper is to provide a protocol for a systematic review on MOOC evaluation methods. Methods: We will use the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) guidelines for reporting this protocol. We developed a population, intervention, comparator, and outcome (PICO) framework to guide the search strategy, based on the overarching question, “What methods have been used to evaluate MOOCs?” The review will follow six stages: 1) literature search, 2) article selection, 3) data extraction, 4) quality appraisal, 5) data analysis, and 6) data synthesis. Results: The systematic review is ongoing. We completed the data searches and data abstraction in October and November 2018. We are now analyzing the data and expect to complete the systematic review by March 2019. Conclusions: This systematic review will provide a useful summary of the methods used for evaluation of MOOCs and the strengths and limitations of each approach. It will also identify gaps in the literature and areas for future work. International Registered Report Identifier (IRRID): DERR1-10.2196/12087

Background: Physicians´ lack of knowledge contributes to underuse of insulin and poor glycemic control in adults with diabetes mellitus (DM). Traditional continuing medical education have limited efficacy, and new approaches are required. Objective: We report the design of a trial to assess the educational efficacy of InsuOnline, a game for education of primary care physicians (PCPs). The goal of InsuOnline was to improve appropriate initiation and adjustment of insulin for the treatment of DM. InsuOnline was designed to be educationally adequate, self-motivating, and attractive. Methods: A multidisciplinary team of endocrinologists, experts in medical education, and programmers, was assembled for the design and development of InsuOnline. Currently, we are conducting usability and playability tests, with PCPs and medical students playing the game on a desktop computer. Adjustments will be made based on these results. An unblinded randomized controlled trial with PCPs who work in the city of Londrina, Brazil, will be conducted to assess the educational validity of InsuOnline on the Web. In this trial, 64 PCPs will play InsuOnline, and 64 PCPs will undergo traditional instructional activities (lecture and group discussion). Knowledge on how to initiate and adjust insulin will be assessed by a Web-based multiple choice questionnaire, and attitudes regarding diabetes/insulin will be assessed by Diabetes Attitude Scale 3 at 3 time points—before, immediately after, and 6 months after the intervention. Subjects´ general impressions on the interventions will be assessed by a questionnaire. Software logs will be reviewed. Results: To our knowledge, this is the first research with the aim of assessing the educational efficacy of a computer game for teaching PCPs about insulin therapy in DM. We describe the development criteria used for creating InsuOnline. Evaluation of the game using a randomized controlled trial design will be done in future studies. Conclusions: We demonstrated that the design and development of a game for PCPs education on insulin is possible with a multidisciplinary team. InsuOnline can be an attractive option for large-scale continuous medical education to help improving PCPs´ knowledge on insulin therapy and potentially improving DM patients´ care. Trial Registration: Clinicaltrials.gov: NCT01759953; http://clinicaltrials.gov/show/NCT01759953 (Archived by WebCite at http://www.webcitation.org/6Dq8Vc7a6).

Background: Particularly in rural regions, factors such as lower physician density and long travel distances complicate adequate outpatient care. However, urban regions can also be affected by deficits in care, for example, long waiting times. One model of care intending to improve the situation is the implementation of video consultations. The study protocol presents the methodology of the research project titled “Preference-based implementation of the video consultation in urban and rural regions” funded by the German Federal Joint Committee (funding number 01VSF20011). Objective: This study aims to identify existing barriers to the use of video consultation and the preferences of insured individuals and physicians as well as psychotherapists in order to optimize its design and thus increase acceptance and use of video consultations in urban and rural regions. Methods: Built on a mixed methods approach, this study first assesses the status quo of video consultation use through claims data analysis and carries out a systematic literature review on barriers and promoting factors for the use of video consultations. Based on this preliminary work, focus groups are conducted in order to prepare surveys with insureds as well as physicians and psychotherapists in the second study phase. The central element of the survey is the implementation of discrete choice experiments to elicit relevant preferences of (potential) user groups and service providers. The summarized findings are discussed in a stakeholder workshop and translated into health policy recommendations. Results: The methodological approach used in this study is the focus of this paper. The study is still ongoing and will continue until March 2024. The first study phase has already been completed, in which preliminary work has been done on potential applications and hurdles for the use of video consultations. Currently, the survey is being conducted and analyses are being prepared. Conclusions: This study is intended to develop a targeted strategy for health policy makers based on actual preferences and perceived obstacles to the use of video consultations. The results of this study will contribute to further user-oriented development of the implementation of video consultations in German statutory health insurance. Furthermore, the iterative and mixed methods approach used in this study protocol is also suitable for a variety of other research projects.

Background: Nursing home residents are at high risk of complications and death due to COVID-19. Lack of resources, both human and material, amplifies the likelihood of contamination in these facilities where a single employee can contaminate dozens of residents and colleagues. Improving the dissemination of and adhesion to infection prevention and control (IPC) guidelines is therefore essential. Serious games have been shown to be effective in developing knowledge and in increasing engagement, and could motivate nursing home employees to change their IPC practices. Objective: Our aim is to assess the impact of “Escape COVID-19,” a serious game designed to enhance knowledge and application of IPC procedures, on the intention of nursing home employees to change their IPC practices. Methods: We will carry out a web-based randomized controlled trial following the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth) guidelines and incorporating relevant elements of CHERRIES (Checklist for Reporting Results of Internet E-Surveys). Participants will be randomized to either the control or the serious game (intervention) group. First, both groups will be asked to answer a questionnaire designed to gather demographic data and assess baseline knowledge. The control group will then receive a quick reminder of the current national guidelines and links to IPC guidelines for health care professionals, while the other group will play the game. Both groups will then have to answer a second questionnaire designed to assess their willingness to change their IPC practices after having followed their respective material. After completing this questionnaire, they will be granted access to the material presented to the group they were not assigned to and receive a course completion certificate. The primary outcome will be the proportion of participants willing to change their IPC practices according to group. Secondary outcomes will include the analysis of specific questions detailing the exact changes considered by the participants. Factors associated with participant willingness or reluctance to change behavior will also be assessed. Attrition will also be assessed at each stage of the study. Results: The study protocol has been presented to our regional ethics committee (Req-2020-01262), which issued a declaration of no objection as such projects do not fall within the scope of the Swiss federal law on human research. Data collection began on November 5, 2020, and should be completed by December 4, 2020. Conclusions: This study should determine whether “Escape COVID-19,” a serious game designed to improve compliance with COVID-19 safe practices, modifies the intention to follow IPC guidelines among nursing home employees. Trial Registration:

Background: Mobile health, predominantly wearable technology and mobile apps, have been considered in Parkinson disease to provide valuable ecological data between face-to-face visits and improve monitoring of motor symptoms remotely. Objective: We explored the feasibility of using a technology-based mHealth platform comprising a smartphone in combination with a smartwatch and a pair of smart insoles, described in this study as the PD_manager system, to collect clinically meaningful data. We also explored outcomes and disease-related factors that are important determinants to establish feasibility. Finally, we further validated a tremor evaluation method with data collected while patients performed their daily activities. Methods: PD_manager trial was an open-label parallel group randomized study.The mHealth platform consists of a wristband, a pair of sensor insoles, a smartphone (with dedicated mobile Android apps) and a knowledge platform serving as the cloud backend. Compliance was assessed with statistical analysis and the factors affecting it using appropriate regression analysis. The correlation of the scores of our previous algorithm for tremor evaluation and the respective Unified Parkinson’s Disease Rating Scale estimations by clinicians were explored. Results: Of the 75 study participants, 65 (87%) completed the protocol. They used the PD_manager system for a median 11.57 (SD 3.15) days. Regression analysis suggests that the main factor associated with high use was caregivers’ burden. Motor Aspects of Experiences of Daily Living and patients’ self-rated health status also influence the system’s use. Our algorithm provided clinically meaningful data for the detection and evaluation of tremor. Conclusions: We found that PD patients, regardless of their demographics and disease characteristics, used the system for 11 to 14 days. The study further supports that mHealth can be an effective tool for the ecologically valid, passive, unobtrusive monitoring and evaluation of symptoms. Future studies will be required to demonstrate that an mHealth platform can improve disease management and care.

Background: Drug use disorder has high potential for relapse and imposes an enormous burden on public health in China. Since the promulgation of the Anti-drug law in 2008, community-based rehabilitation has become the primary approach to treat drug addiction. However, multiple problems occurred in the implementation process, leading to a low detoxification rate in the community. Mobile health (mHealth) serves as a promising tool to improve the effectiveness and efficiency of community-based rehabilitation. Community-based addiction rehabilitation electronic system (CAREs) is an interactive system for drug users and their assigned social workers. Objective: The study aimed to examine the feasibility and preliminary efficacy of CAREs in community-based rehabilitation from the perspective of drug users and social workers in Shanghai, China. Methods: In this pilot randomized controlled trial, 40 participants were recruited from the community in Shanghai from January to May 2019. Participants randomized to the intervention group (n=20) received CAREs + community-based rehabilitation, while participants in the control group (n=20) received community-based rehabilitation only for 6 months. CAREs provided education, assessment, and SOS (support) functions for drug users. The assigned social workers provided service and monitored drug use behavior as usual except that the social workers in the intervention group could access the webpage end to obtain drug users’ information and fit their routine workflow into CAREs. The primary outcome was the feasibility of CAREs, reflected in the overall proportion and frequency of CAREs features used in both app and webpage end. The secondary outcomes were the effectiveness of CAREs, including the percentage of drug-positive samples, longest period of abstinence, contact times with social workers, and the change of Addiction Severity Index (ASI) from baseline to the 6-month follow-up. Results: The number of participants logged in to the app ranged from 7 to 20 per week, and CAREs had relatively high levels of continued patient use. Drug users preferred assessment and education features in the app end while their social workers showed high levels of use in urine results record and viewing assessment results on the webpage end. After the 6-month intervention, 3.3% (17/520) of samples in the intervention group and 7.5% (39/520) in the control group were drug-positive (F=4.358, P=.04). No significant differences were noted between the control and intervention groups in terms of longest duration of abstinence, number of contact times and ASI composite scores. Conclusions: The study preliminarily demonstrated that with relatively good feasibility and acceptability, CAREs may improve the effectiveness and efficiency of the community-based rehabilitation, which provided instruction for further improvement of the system. Trial Registration: ClinicalTrials.gov NCT03451344; https://clinicaltrials.gov/ct2/show/NCT03451344

Background: Shared decision making (SDM) is recognized as a person-centered approach to improving health care quality and outcomes. Few digital interventions to improve SDM have been tested in child and adolescent mental health (CAMH) settings. One such intervention is Power Up, a mobile phone app for young people (YP), which has shown some evidence of promise that YP who received Power Up reported greater levels of SDM. However, even though parents play a critical role in CAMH care and treatment, they often feel excluded from services. Objective: This protocol is for a pilot trial to determine the feasibility of a large-scale randomized trial to develop and evaluate a Web app called Power Up for Parents (PUfP) to support parents and promote involvement in CAMH decisions. Methods: A 2-stage process, consisting of the development stage and pilot-testing stage of the initial PUfP prototype, will be conducted. At the development stage, a qualitative study with parents and clinicians will be conducted. The interviews will aim to capture the experience of making CAMH decisions, preferences for involvement in SDM, and determine situations within which PUfP can be useful. At the pilot-testing stage, up to 90 parents and their clinicians will be invited to participate in the testing of the prototype. Parents will be randomly allocated to receive the intervention or be part of the control group. This study design will allow us to assess the acceptability and usefulness of PUfP in addition to examining the feasibility of a prospective randomized trial. Clinicians’ perceptions of the prototype and how it has influenced parents’ involvement in SDM will also be examined. Results: Recruitment began in January 2019 and is scheduled to last for 10 months. Interviews and baseline data collection are currently in progress. To date, 11 CAMH sites have been recruited to take part in the study. It is anticipated that data collection will be completed by October 2019. Conclusions: The lack of parents’ involvement in CAMH care and treatment can lead to higher rates of dropout from care and lower adherence to therapeutic interventions. There are significant benefits to be gained globally if digital SDM interventions are adopted by parents and shown to be successful in CAMH settings. Trial Registration: ISRCTN Registry ISRCTN39238984; http://www.isrctn.com/ISRCTN39238984 International Registered Report Identifier (IRRID): DERR1-10.2196/14571

Background: Health measurement guides policies and health care decisions are necessary to describe and attain the quintuple aim of improving patient experience, population health, care team well-being, health care costs, and equity. In the primary care setting, patient-reported outcome measurement allows outcome comparisons within and across settings and helps improve the clinical management of patients. However, these digital patient-reported outcome measures (PROMs) are still not adapted to the clinical context of primary health care, which is an indication of the complexity of integrating these tools in this context. We must then gather evidence of their impact on chronic disease management in primary health care and understand the characteristics of effective implementation. Objective: We will conduct a systematic review to identify and assess the impact of electronic PROMs (ePROMs) implementation in primary health care for chronic disease management. Our specific objectives are to (1) determine the impact of ePROMs in primary health care for chronic disease management and (2) compare and contrast characteristics of effective ePROMs’ implementation strategies. Methods: We will conduct a systematic review of the literature in accordance with the guidelines of the Cochrane Methods Group and in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for its reporting. A specific search strategy was developed for relevant databases to identify studies. Two reviewers will independently apply the inclusion criteria using full texts and will extract the data. We will use a 2-phase sequential mixed methods synthesis design by conducting a qualitative synthesis first, and use its results to perform a quantitative synthesis. Results: This study was initiated in June 2022 by assembling the research team and the knowledge transfer committee. The preliminary search strategy will be developed and completed in September 2022. The main search strategy, data collection, study selection, and application of inclusion criteria were completed between October and December 2022. Conclusions: Results from this review will help support implementation efforts to accelerate innovations and digital adoption for primary health care and will be relevant for improving clinical management of chronic diseases and health care services and policies. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42022333513; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=333513

Background: Patients with colorectal cancer (CRC) receiving chemotherapy often experience psychoneurological symptoms (PNS; ie, fatigue, depression, anxiety, sleep disturbance, pain, and cognitive dysfunction) that negatively impact both patients’ and their caregivers’ health outcomes. Limited information is available on PNS management for CRC patient and caregiver dyads. Objective: The purposes of this study are to (1) develop a web-based dyadic intervention for patients with CRC receiving chemotherapy and their caregivers (CRCweb) and (2) evaluate the feasibility, acceptability, and preliminary effects of CRCweb among patient-caregiver dyads in a cancer clinic. Methods: A mixed methods approach will be used. Semistructured interviews among 8 dyads will be conducted to develop CRCweb. A single-group pre- and posttest clinical trial will be used to examine the feasibility, acceptability, and preliminary effects of the intervention (CRCweb) among 20 dyads. Study assessments will be conducted before (T1) and after intervention (T2). Content analysis will be performed for semistructured interviews. Descriptive statistics will be calculated separately for patients and caregivers, and pre-post paired t tests will be used to evaluate treatment effects. Results: This study was funded in November 2022. As of April 2023, we have obtained institutional review board approval and completed clinical trial registration and are currently recruiting patient-caregiver dyads in a cancer clinic. The study is expected to be completed in October 2024. Conclusions: Developing a web-based dyadic intervention holds great promise to reduce the PNS burden in patients with CRC receiving chemotherapy and their caregivers. The findings from this study will advance intervention development and implementation of symptom management and palliative care for patients with cancer and their caregivers. Trial Registration: ClinicalTrials.gov NCT05663203; https://clinicaltrials.gov/ct2/show/NCT05663203

Background: Telemonitoring of activities of daily living (ADLs) offers significant potential for gaining a deeper insight into the home care needs of older adults experiencing cognitive decline, particularly those living alone. In 2016, our team and a health care institution in Montreal, Quebec, Canada, sought to test this technology to enhance the support provided by home care clinical teams for older adults residing alone and facing cognitive deficits. The Support for Seniors’ Autonomy program (SAPA [Soutien à l’autonomie des personnes âgées]) project was initiated within this context, embracing an innovative research approach that combines action research and design science. Objective: This paper presents the research protocol for the SAPA project, with the aim of facilitating the replication of similar initiatives in the future. The primary objectives of the SAPA project were to (1) codevelop an ADL telemonitoring system aligned with the requirements of key stakeholders, (2) deploy the system in a real clinical environment to identify specific use cases, and (3) identify factors conducive to its sustained use in a real-world setting. Given the context of the SAPA project, the adoption of an action design research (ADR) approach was deemed crucial. ADR is a framework for crafting practical solutions to intricate problems encountered in a specific organizational context. Methods: This project consisted of 2 cycles of development (alpha and beta) that involved cyclical repetitions of stages 2 and 3 to develop a telemonitoring system for ADLs. Stakeholders, such as health care managers, clinicians, older adults, and their families, were included in each codevelopment cycle. Qualitative and quantitative data were collected throughout this project. Results: The first iterative cycle, the alpha cycle, took place from early 2016 to mid 2018. The first prototype of an ADL telemonitoring system was deployed in the homes of 4 individuals receiving home care services through a public health institution. The prototype was used to collect data about care recipients’ ADL routines. Clinicians used the data to support their home care intervention plan, and the results are presented here. The prototype was successfully deployed and perceived as useful, although obstacles were encountered. Similarly, a second codevelopment cycle (beta cycle) took place in 3 public health institutions from late 2018 to late 2022. The telemonitoring system was installed in 31 care recipients’ homes, and detailed results will be presented in future papers. Conclusions: To our knowledge, this is the first reported ADR project in ADL telemonitoring research that includes 2 iterative cycles of codevelopment and deployment embedded in the real-world clinical settings of a public health system. We discuss the artifacts, generalization of learning, and dissemination generated by this protocol in the hope of providing a concrete and replicable example of research partnerships in the field of digital health in cognitive aging.

Background: It is predicted that digital health technologies that incorporate artificial intelligence will transform health care delivery in the next decade. Little research has explored how emerging trends in artificial intelligence–driven digital health technologies may influence the relationship between nurses and patients. Objective: The purpose of this scoping review is to summarize the findings from 4 research questions regarding emerging trends in artificial intelligence–driven digital health technologies and their influence on nursing practice across the 5 domains outlined by the Canadian Nurses Association framework: administration, clinical care, education, policy, and research. Specifically, this scoping review will examine how emerging trends will transform the roles and functions of nurses over the next 10 years and beyond. Methods: Using an established scoping review methodology, MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Embase, PsycINFO, Cochrane Database of Systematic Reviews, Cochrane Central, Education Resources Information Centre, Scopus, Web of Science, and Proquest databases were searched. In addition to the electronic database searches, a targeted website search will be performed to access relevant grey literature. Abstracts and full-text studies will be independently screened by 2 reviewers using prespecified inclusion and exclusion criteria. Included literature will focus on nursing and digital health technologies that incorporate artificial intelligence. Data will be charted using a structured form and narratively summarized. Results: Electronic database searches have retrieved 10,318 results. The scoping review and subsequent briefing paper will be completed by the fall of 2020. Conclusions: A symposium will be held to share insights gained from this scoping review with key thought leaders and a cross section of stakeholders from administration, clinical care, education, policy, and research as well as patient advocates. The symposium will provide a forum to explore opportunities for action to advance the future of nursing in a technological world and, more specifically, nurses’ delivery of compassionate care in the age of artificial intelligence. Results from the symposium will be summarized in the form of a briefing paper and widely disseminated to relevant stakeholders.

Background: Cardiac pain has been widely considered to be the primary indicator of coronary artery disease. The presentation of cardiac pain and associated symptoms vary in women, making it challenging to interpret as cardiac, possibly cardiac, or noncardiac. Women prefer to consult with family and friends instead of seeking immediate medical care. Objective: This study aimed to assess the user performance (ie, ease of use, efficiency, and errors) and user satisfaction (System Usability Scale; SUS) of a progressive web application for women with cardiac pain. Methods: Following ethics approval, a purposive sample of women aged >18 years with cardiac pain or associated symptoms lasting >3 months and able to speak and read English was recruited to participate in 2 iterative usability testing cycles. The first cycle assessed the performance of and satisfaction with at heart using a web application, and the second cycle assessed the performance of and satisfaction with at heart across various Android and iOS devices. In total, 2 investigators recorded user comments and documented problems. At the end of the testing session, the participants completed the SUS and 4 semistructured interview questions. Results: In total, 10 eligible women participated in usability testing from March 31, 2020, to April 17, 2020 (cycle 1), and from November 17, 2020, to November 30, 2020 (cycle 2). Women across usability testing cycles had a mean age of 55.6 (SD 7.3) years, and most (9/10, 90%) were well educated. In total, 50% (5/10) were employed full or part time, and 60% (6/10) earned >CAD $70,000 (US $48,881.80) annually. Participants across 2 testing cycles reported the overall usability of the at heart progressive web application as highly acceptable (mean SUS score 81.75, SD 10.41). In total, 90% (9/10) of participants rated the user-friendliness of at heart as good or excellent. All participants (10/10, 100%) thought at heart was easy to use and efficient. Only 2 testing errors were noted as high priority; these were low contrast or small font and clarification that the chatbot was not a real person. User satisfaction was assessed using themes that emerged from the debrief and 4 semistructured interview questions; at heart was engaging, comprehensive, understandable, credible, relevant, affirming, personalized, and innovative. Conclusions: This study provides initial support for the at heart progressive web application for women living with cardiac pain and symptoms. Ongoing evaluations in phases 3 and 4 should aim to examine the feasibility and acceptability of and the extent of engagement with the at heart core feature set: Heart Check, Wellness Check, and the library. In addition to assessing effectiveness in the phase-4 effectiveness-implementation hybrid trial (type I), describing and better understanding the context for implementation (eg, race and ethnicity and geography) will be necessary.

Background: Mobile health (mHealth) is a low-cost method to improve health for patients with diabetes seeking care in safety-net emergency departments, resulting in improved medication adherence and self-management. Additions of social support to mHealth interventions could further enhance diabetes self-management by increasing the gains and the postintervention maintenance. Objective: We assessed outcomes of an unblinded, parallel, equal-allocation randomized phase-III trial that tested a social support mHealth intervention to improve emergency department patients’ diabetes self-management. Methods: Patients with glycated hemoglobin (HbA1c) levels of ≥8.5% mg/dL and a text-capable phone were recruited during their emergency department visit for any reason (diabetes related or not) at a US public hospital along with a friend or family member as a supporter. Patients received 6 months of the Trial to Examine Text Messaging in Emergency Department Patients With Diabetes self-management mHealth program. Supporters were randomized to receive either (1) an mHealth social support program (Family and Friends Network Support)—daily SMS text messages guiding supporters to provide diabetes-related social support—or (2) a non-mHealth social support program as an active control—pamphlet-augmented social support with Family and Friends Network Support content. Point-of-care HbA1c level, self-reported diabetes self-care activities, medication adherence, and safety events were collected. Mixed-effects linear regression models analyzed group differences at the end of the intervention (6 months) and the postintervention phase (12 months) for HbA1c level and behavioral outcomes. Results: A total of 166 patients were randomized. In total, 8.4% (n=14) reported type 1 diabetes, 66.9% (n=111) reported type 2 diabetes, and 24.7% (n=41) did not know their diabetes type; 50% (n=83) reported using insulin for diabetes management. Trial follow-up was completed with 58.4% (n=97) of the patients at 6 months and 63.9% (n=106) of the patients at 12 months. Both groups showed significant HbA1c level improvements (combined group change=1.36%, SD 2.42% mg/dL; 95% CI 0.87-1.83; P<.001), with no group difference (group mean difference=0.14%, SD 4.88% mg/dL; 95% CI −1.11 to 0.83; P=.87) at 6 months. At 12 months, both groups maintained their improved HbA1c levels, with a combined mean change from 6 months of 0.06% (SD 1.89% mg/dL; 95% CI −0.34 to 0.47; P=.76) and no clinically meaningful difference between groups. No differences were observed in safety events. In subgroup analyses, patients recently diagnosed with diabetes in the mHealth social support group improved their glycemic control compared to the standard social support group (between-group difference of 1.96%, SD 9.59% mg/dL; 95% CI −3.81 to −0.125; P=.04). Conclusions: A 6-month change in HbA1c level did not differ by mode of social support in persons using an existing patient-focused mHealth diabetes self-management program, but both groups improved in self-management and glycemic control. Newly diagnosed patients with diabetes benefited most from mHealth-augmented social support. Trial Registration: ClinicalTrials.gov NCT03178773; https://clinicaltrials.gov/study/NCT03178773

Introduction Exercise interventions have a strong evidence base for falls prevention. However, exercise can be challenging to implement and often has limited reach and poor adherence. Digital technology provides opportunities for both increased access to the intervention and support over time. Further knowledge needs to be gained regarding the effectiveness of completely self-managed digital exercise interventions. The main objective of this study is to compare the effectiveness of a self-managed digital exercise programme, Safe Step, in combination with monthly educational videos with educational videos alone, on falls over 1 year in older community-dwelling adults. Methods and analysis A two-arm parallel randomised controlled trial will be conducted with at least 1400 community-living older adults (70+ years) who experience impaired balance. Participants will be recruited throughout Sweden with enrolment through the project website.

Background: Coronavirus disease (COVID-19) has spread globally with far-reaching, significant, and unprecedented impacts on health and everyday life. Threats to mental health, psychological safety, and well-being are now emerging, increasing the impact of this virus on world health. Providing support for these challenges is difficult because of the high number of people requiring support in the context of a need to maintain physical distancing. This protocol describes the use of SMS text messaging (Text4Hope) as a convenient, cost-effective, and accessible population-level mental health intervention. This program is evidence-based, with prior research supporting good outcomes and high user satisfaction. Objective: The project goal is to implement a program of daily supportive SMS text messaging (Text4Hope) to reduce distress related to the COVID-19 crisis, initially among Canadians. The prevalence of stress, anxiety, and depressive symptoms; the demographic correlates of the same; and the outcomes of the Text4Hope intervention in mitigating distress will be evaluated. Methods: Self-administered anonymous online questionnaires will be used to assess stress (Perceived Stress Scale), anxiety (Generalized Anxiety Disorder-7 scale [GAD-7]), and depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]). Data will be collected at baseline (onset of SMS text messaging), the program midpoint (6 weeks), and the program endpoint (12 weeks). Results: Data analysis will include parametric and nonparametric techniques, focusing on primary outcomes (ie, stress, anxiety, and depressive symptoms) and metrics of use, including the number of subscribers and user satisfaction. Given the large size of the data set, machine learning and data mining methods will also be used. Conclusions: This COVID-19 project will provide key information regarding prevalence rates of stress, anxiety, and depressive symptoms during the pandemic; demographic correlates of distress; and outcome data related to this scalable population-level intervention. Information from this study will be valuable for practitioners and useful for informing policy and decision making regarding psychological interventions during the pandemic.

Background: Nonimmersive virtual reality training (NIVRT) can be used to continue rehabilitative exercise for stroke recovery at home after discharge from inpatient or outpatient therapy. Objective: The objectives of this randomized controlled feasibility trial were to assess home-based NIVRT as telerehabilitation with patients living with stroke, and its potential to improve standing function and gait. Methods: Patients approaching discharge from inpatient or outpatient stroke rehabilitation were randomly allocated to NIVRT or iPad interventions. NIVRT provided interactive games and exercises designed to improve balance, stepping, and aerobic capacity. iPad apps addressed cognition and fine motor skills. Participants were visited in their homes by a physiotherapist, taught to use the program, and asked to do 30 minutes of exercise 5 days a week for 6 weeks, asynchronously. Feasibility was assessed by measuring recruitment, adherence, ability to set up and learn NIVRT, enjoyment, intent to continue, perception of impact, and safety. Participants completed assessments of standing balance, gait, and general function, before and after the intervention, by a blinded assessor. Results: NIVRT participants (n=11; 10 male participants; mean age 64, SD 12 years) did an average of 26 sessions (total 700 minutes), while iPad participants (n=9; 6 male participants; mean age 61, SD 20 years) did an average of 33 sessions (total 1241 minutes). Space was tight in 5 homes. All but 1 participant learned NIVRT and progressed. Most enjoyed it and felt that it improved their recovery. There were no serious adverse events. Most assessments showed improvement over time for both groups. Conclusions: Home-based NIVRT is safe and feasible to continue rehabilitative exercise after discharge. More research on efficacy and effectiveness in this population is required. Clinical Trial: ClinicalTrials.gov NCT03261713; https://clinicaltrials.gov/study/NCT03261713

Introduction An online interactive repository of available medication adherence technologies may facilitate their selection and adoption by different stakeholders. Developing a repository is among the main objectives of the European Network to Advance Best practices and technoLogy on medication adherencE (ENABLE) COST Action (CA19132). However, meeting the needs of diverse stakeholders requires careful consideration of the repository structure. Methods and analysis A real-time online Delphi study by stakeholders from 39 countries with research, practice, policy, patient representation and technology development backgrounds will be conducted. Eleven ENABLE members from 9 European countries formed an interdisciplinary steering committee to develop the repository structure, prepare study protocol and perform it. Definitions of medication adherence technologies and their attributes were developed iteratively through literature review, discussions within the steering committee and ENABLE Action members, following ontology development recommendations. Three domains ( product and provider information (D1), medication adherence descriptors (D2) and evaluation and implementation (D3 )) branching in 13 attribute groups are proposed: product and provider information, target use scenarios, target health conditions, medication regimen, medication adherence management components, monitoring/measurement methods and targets, intervention modes of delivery, target behaviour determinants, behaviour change techniques, intervention providers, intervention settings, quality indicators and implementation indicators . Stakeholders will evaluate the proposed definition and attributes’ relevance, clarity and completeness and have multiple opportunities to reconsider their evaluations based on aggregated feedback in real-time. Data collection will stop when the predetermined response rate will be achieved. We will quantify agreement and perform analyses of process indicators on the whole sample and per stakeholder group. Ethics and dissemination Ethical approval for the COST ENABLE activities was granted by the Malaga Regional Research Ethics Committee. The Delphi protocol was considered compliant regarding data protection and security by the Data Protection Officer from University of Basel. Findings from the Delphi study will form the basis for the ENABLE repository structure and related activities.

Background: Symptom checker apps (SCAs) are accessible tools that provide early symptom assessment for users. The ethical, legal, and social implications of SCAs and their impact on the patient-physician relationship, the health care providers, and the health care system have sparsely been examined. This study protocol describes an approach to investigate the possible impacts and implications of SCAs on different levels of health care provision. It considers the perspectives of the users, nonusers, general practitioners (GPs), and health care experts. Objective: We aim to assess a comprehensive overview of the use of SCAs and address problematic issues, if any. The primary outcomes of this study are empirically informed multi-perspective recommendations for different stakeholders on the ethical, legal, and social implications of SCAs. Methods: Quantitative and qualitative methods will be used in several overlapping and interconnected study phases. In study phase 1, a comprehensive literature review will be conducted to assess the ethical, legal, social, and systemic impacts of SCAs. Study phase 2 comprises a survey that will be analyzed with a logistic regression. It aims to assess the user degree of SCAs in Germany as well as the predictors for SCA usage. Study phase 3 will investigate self-observational diaries and user interviews, which will be analyzed as integrated cases to assess user perspectives, usage pattern, and arising problems. Study phase 4 will comprise GP interviews to assess their experiences, perspectives, self-image, and concepts and will be analyzed with the basic procedure by Kruse. Moreover, interviews with health care experts will be conducted in study phase 3 and will be analyzed by using the reflexive thematical analysis approach of Braun and Clark. Results: Study phase 1 will be completed in November 2021. We expect the results of study phase 2 in December 2021 and February 2022. In study phase 3, interviews are currently being conducted. The final study endpoint will be in February 2023. Conclusions: The possible ethical, legal, social, and systemic impacts of a widespread use of SCAs that affect stakeholders and stakeholder groups on different levels of health care will be identified. The proposed methodological approach provides a multifaceted and diverse empirical basis for a broad discussion on these implications. Trial Registration: German Clinical Trials Register (DRKS) DRKS00022465; https://tinyurl.com/yx53er67

Background: Chronic pain is a highly prevalent condition that requires multidisciplinary treatment. However, in the United Kingdom, access to specialist pain clinics where patients can receive medical multidisciplinary treatment is limited, and provision varies between health boards. As such, self-management of chronic pain using digital tools has been gaining traction recently, but evidence of its effectiveness from clinical-based trials focuses mainly on quantitative outcomes. Objective: This systematic review aims to identify, appraise, and synthesize qualitative evidence on patients’ experiences with digital health interventions (DHIs) for the management of chronic pain. Methods: This systematic review will consider qualitative and mixed methods studies that explore the experience of patients (aged 18 years and older) with chronic pain engaging in DHIs to manage their pain. MEDLINE Ovid, PubMed, Embase, CINAHL, PsycINFO, and Scopus databases will be searched for published studies. The systematic review will be conducted in accordance with the ENTREQ (Enhancing Transparency in Reporting the Synthesis of Qualitative Research) guidelines. Following the 3-step thematic synthesis methodology of Thomas and Harden, titles and abstracts will be screened by 2 independent reviewers (AM and HM), and a third reviewer (MI or FM) will resolve any conflict that arises before the full-text screening. The Critical Appraisal Skills Programme checklist tool will be used to critically appraise the included studies. The extracted data will be imported to NVivo (QSR International), where thematic synthesis will be used to derive analytical themes from the included studies. Results: Themes that encapsulate the patient experience will be identified from qualitative evidence, and these themes will shed light on the perceived benefits and disadvantages, usability, acceptability, and the overall impact digital tools can have on the lives of those with chronic pain. Conclusions: This systematic review will identify, appraise, and synthesize the overall experience of patients engaging in DHI to manage a diverse range of chronic pain conditions. By elaborating the patient experience through qualitative analysis, the findings from this review will enhance our current understanding of the experiences of patients with chronic pain using digital tools for the self-management of their pain and highlight what person-centered elements are essential for future DHI development. Trial Registration: PROSPERO CRD42023445100; http://tinyurl.com/4z77khfs International Registered Report Identifier (IRRID): DERR1-10.2196/52469

Background: The process of designing a digital health intervention (DHI)—also referred to as mobile health or eHealth—spans needs assessments, technical functionality and feasibility, user satisfaction, effectiveness, impact, and value. These interventions are causing a rapid evolution in the landscape of health care. Multiple studies have shown their propensity to extend both the quality and reach of interventions. However, failure to improve DHI design is linked to failed uptake and health outcomes. This dilemma is further conflicted by the colliding backdrops of the digital and health industries, both of which approach, understand, and involve end users differently in the framing of a DHI. Objective: The objective of this systematic review is to assess the challenges to incorporating end users in the design stage of digital health interventions, to identify key pain points, and to identify limitations and gaps for areas of future investigation. Methods: The PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols) checklist will be used to structure this protocol. A systematic search of the PsycINFO, PubMed (MEDLINE), Web of Science, CINAHL, Scopus, and IEEE Xplore databases will be conducted. Additionally, the PerSPEcTiF guidelines for complex interventions will be consulted. Two reviewers will independently screen the titles and abstracts of the identified references and select studies according to the eligibility criteria. Any discrepancies will then be discussed and resolved. Two reviewers will independently extract and validate data from the included studies into a standardized form and conduct quality appraisal. Results: As of February 2021, we have completed a preliminary literature search examining challenges to the incorporation of end users in the design stage of DHIs. Systematic searches, data extraction and analysis, and writing of the systematic review are expected to be completed by December 2021. Conclusions: This systematic review aims to provide an effective summary of key pain points toward incorporating end users in DHIs. Results from this review will provide an evidence base for a better approach to end user involvement in the interest of improving efficacy and uptake of DHIs.

Background Cardiac rehabilitation programs aim to avoid further progression and relapse of cardiovascular diseases (CVDs). Patients with CVDs undergoing rehabilitation often experience difficulties in integrating and transferring the learned health behaviors into their daily life after returning home. This includes regular physical activity (PA) and sufficient fruit and vegetable consumption (FVC). eHealth individualized interventions have shown to be effective in increasing PA and FVC in home settings. As WeChat is the most popular social media site in China, this should be used for the intervention. The aim of this study is to develop and examine a WeChat mini program-based intervention on PA and FVC promotion among Chinese cardiovascular patients in home-based rehabilitation. Methods The study will adopt a randomized controlled trial (RCT), comprising a WeChat mini program-based intervention group and a waiting-list control group. The intervention content will be designed based on the Health Action Process Approach (HAPA). One hundred fifty-eight outpatients will be recruited from the cardiac rehabilitation center of a hospital in southern China and randomly assigned to one of the two groups. During the 10-week duration of the intervention, participants will be invited to access a WeChat mini program comprising two Modules. Module 1 provides weekly learning sessions addressing PA and FVC simultaneously for 10 weeks. Module 2 provides a platform, where participants can review their progress with Module 1 at any time and attend incentive activities aiming at promoting engagement and retention. The outcome variables include PA (mins/week), FVC (portion/day), healthy lifestyle (the synthesis of PA and FVC), social-cognitive predictors of behavior change (risk perception, outcome expectancies, self-efficacy, intention, planning, social support, and action control) as well as health outcomes (Body mass index, depression, and quality of life). Data collection will be implemented at pre-test, post-test and a post-test after 3-month respectively. Discussion The current study will be significant to understand how such a cost-effective social media mini program-based intervention enables participants to adopt and maintain a healthy lifestyle. If it is effective, it will enrich home-based cardiac rehabilitation approaches which can in turn save the lives of patients as well as much monetary, time and other investments. Trial Registration The study was registered at ClinicalTrials.gov (Identifier: NCT03636724; Last update posted: July 28, 2020).

Introduction Increasing demand for healthcare services worldwide has led to unprecedented challenges in managing patient flow and delivering timely care in emergency care settings. Overcrowding, prolonged waiting times, reduced patient satisfaction and increased mortality are some of the consequences of this increased demand.

Background: An estimated 40% of people living with HIV smoke cigarettes. Although smoking rates in the United States have been declining in recent years, people living with HIV continue to smoke cigarettes at twice the rate of the general population. Mobile health (mHealth) technology is an effective tool for people living with a chronic illness, such as HIV, as currently 84% of households in the United States report that they have a smartphone. Although many studies have used mHealth interventions for smoking cessation, few studies have recruited people living with HIV who smoke. Objective: The objective of the pilot randomized controlled trial (RCT) is to examine the feasibility, acceptability, and preliminary efficacy of the Sense2Quit App as a tool for people living with HIV who are motivated to quit smoking. Methods: The Sense2Quit study is a 2-arm RCT for people living with HIV who smoke cigarettes (n=60). Participants are randomized to either the active intervention condition, which consists of an 8-week supply of nicotine replacement therapy, standard smoking cessation counseling, and access to the Sense2Quit mobile app and smartwatch, or the control condition, which consists of standard smoking cessation counseling and a referral to the New York State Smokers’ Quitline. The Sense2Quit app is a mobile app connected through Bluetooth to a smartwatch that tracks smoking gestures and distinguishes them from other everyday hand movements. In the Sense2Quit app, participants can view their smoking trends, which are recorded through their use of the smartwatch, including how often or how much they smoke and the amount of money that they are spending on cigarettes, watch videos with quitting tips, information, and distractions, play games, set reminders, and communicate with a study team member. Results: Enrollment of study participants began in March 2023 and is expected to end in October 2023. All data collection is expected to be completed by the end of January 2024. This RCT will test the difference in outcomes between the control and intervention arms. The primary outcome will be the percentage of participants with biochemically verified 7-day point prevalence smoking or tobacco abstinence at their 12-week follow-up. Results from this pilot study will be disseminated to the research community following the completion of all data collection. Conclusions: The Sense2Quit study leverages mHealth so that it can help smokers improve their efforts at smoking cessation. Our research has the potential to not only increase quitting rates among people living with HIV who may need a prolonged, tailored intervention but also inform further development of mHealth for people living with HIV. This mHealth study will contribute significant findings to the greater mHealth research community, providing evidence as to how mHealth should be developed and tested among the target population.

Background: Black cisgender gay, bisexual, and other sexual minority men (SMM) and transgender women (TW) continue to be heavily affected by HIV. Further research is needed to better understand HIV prevention and care outcomes in this population. In particular, there is a need for research examining the impact of substance use and sleep health on HIV prevention and treatment outcomes among Black SMM and TW. Objective: This paper outlines the study methods being used in the recently launched follow-up study to the Neighborhoods and Networks (N2) study, which we refer to as N2 Part 2 (N2P2). N2P2 aims to address this gap in the literature, build off the findings of the original N2 study, and identify socioenvironmental determinants of health, including whether neighborhood and network factors mediate and moderate these relationships. Methods: Building on the N2 cohort study in Chicago from 2018 to 2022, N2P2 used a prospective longitudinal cohort design and an observational-implementation hybrid approach. With sustained high levels of community engagement, we aim to recruit a new sample of 600 Black SMM and TW participants residing in the Chicago metropolitan statistical area. Participants are asked to participate in 3 study visits across an 18-month study period (1 visit every 9 months). Four different forms of data are collected per wave: (1) an in-person survey, (2) biological specimen collection, (3) a daily remote ecological momentary assessment for 14 days after each study visit, and (4) data from electronic health records. These forms of data collection continue to assess neighborhood and network factors and specifically explore substance use, sleep, immune function, obesity, and the implementation of potential interventions that address relevant constructs (eg, alcohol use and pre-exposure prophylaxis adherence). Results: The N2P2 study was funded in August 2021 by the National Institute of Drug Abuse (R01DA054553 and R21DA053156) and National Heart, Lung, and Blood Institute (R01HL160325). This study was launched in November 2022. Recruitment and enrollment for the first wave of data collection are currently ongoing. Conclusions: The N2P2 study is applying innovative methods to comprehensively explore the impacts of substance use and sleep health on HIV-related outcomes among an HIV status–neutral cohort of Black SMM and TW in Chicago. This study is applying an observational-implementation hybrid design to help us achieve findings that support rapid translation, a critical priority among populations such as Black SMM and TW that experience long-standing inequities with regard to HIV and other health-related outcomes. N2P2 will directly build off the findings that have resulted from the original N2 study among Black SMM and TW in Chicago. These findings provide a better understanding of multilevel (eg, individual, network, and neighborhood) factors that contribute to HIV-related outcomes and viral suppression among Black SMM and TW.

Background: The synthesis of evidence in health care is essential for informed decision-making and policy development. This study aims to validate The Umbrella Collaboration (TU), an innovative, semiautomatic tertiary evidence synthesis methodology, by comparing it with Traditional Umbrella Reviews (TUR), which are currently the gold standard. Objective: This study aimed to evaluate whether TU, an artificial intelligence—assisted, software-driven system for tertiary evidence synthesis, can achieve comparable effectiveness to TURs, while offering a more timely, efficient, and comprehensive approach. In addition, as a secondary objective, the study aims to assess the accessibility and comprehensibility of TU’s outputs to ensure its usability and practical applicability for health care professionals. Methods: This protocol outlines a comparative study divided into 2 main parts. The first part involves a quantitative comparison of results obtained using TU and TURs in geriatrics. We will evaluate the identification, size effect, direction, statistical significance, and certainty of outcomes, as well as the time and resources required for each methodology. Data for TURs will be sourced from Medline (via PubMed), while TU will use artificial intelligence—assisted informatics to replicate the research questions of the selected TURs. The second part of the study assesses the ease of use and comprehension of TU through an online survey directed at health professionals, using interactive features and detailed data access. Results: Expected results include the assessment of concordance in identifying outcomes, the size effect, direction and significance of these outcomes, and the certainty of evidence. In addition, we will measure the operational efficiency of each methodology by evaluating the time taken to complete projects. User perceptions of the ease of use and comprehension of TU will be gathered through detailed surveys. The implementation of new methodologies in evidence synthesis requires validation. This study will determine whether TU can match the accuracy and comprehensiveness of TURs while offering benefits in terms of efficiency and user accessibility. The comparative study is designed to address the inherent challenges in validating a new methodology against established standards. Conclusions: If TU proves as effective as TURs but more time-efficient, accessible, and easily updatable, it could significantly enhance the process of evidence synthesis, facilitating informed decision-making and improving health care. This study represents a step toward integrating innovative technologies into routine evidence synthesis practice, potentially transforming health research.

Background: When introducing artificial intelligence (AI) into clinical care, one of the main objectives is to improve workflow efficiency because AI-based solutions are expected to take over or support routine tasks. Objective: This study sought to synthesize the current knowledge base on how the use of AI technologies for medical imaging affects efficiency and what facilitators or barriers moderating the impact of AI implementation have been reported. Methods: In this systematic literature review, comprehensive literature searches will be performed in relevant electronic databases, including PubMed/MEDLINE, Embase, PsycINFO, Web of Science, IEEE Xplore, and CENTRAL. Studies in English and German published from 2000 onwards will be included. The following inclusion criteria will be applied: empirical studies targeting the workflow integration or adoption of AI-based software in medical imaging used for diagnostic purposes in a health care setting. The efficiency outcomes of interest include workflow adaptation, time to complete tasks, and workload. Two reviewers will independently screen all retrieved records, full-text articles, and extract data. The study’s methodological quality will be appraised using suitable tools. The findings will be described qualitatively, and a meta-analysis will be performed, if possible. Furthermore, a narrative synthesis approach that focuses on work system factors affecting the integration of AI technologies reported in eligible studies will be adopted. Results: This review is anticipated to begin in September 2022 and will be completed in April 2023. Conclusions: This systematic review and synthesis aims to summarize the existing knowledge on efficiency improvements in medical imaging through the integration of AI into clinical workflows. Moreover, it will extract the facilitators and barriers of the AI implementation process in clinical care settings. Therefore, our findings have implications for future clinical implementation processes of AI-based solutions, with a particular focus on diagnostic procedures. This review is additionally expected to identify research gaps regarding the focus on seamless workflow integration of novel technologies in clinical settings. Trial Registration: PROSPERO CRD42022303439; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=303439

Background: The French organized population-based cervical cancer screening (CCS) program transitioned from a cytology-based to a human papillomavirus (HPV)–based screening strategy in August 2020. HPV testing is offered every 5 years, starting at the age of 30 years. In the new program, women are invited to undergo an HPV test at a gynecologist’s, primary care physician’s, or midwife’s office, a private clinic or health center, family planning center, or hospital. HPV self-sampling (HPVss) was also made available as an additional approach. However, French studies reported that less than 20% of noncompliant women performed vaginal self-sampling when a kit was sent to their home. Women with lower income and educational levels participate less in CCS. Lack of information about the disease and the benefits of CCS were reported as one of the major barriers among noncompliant women. This barrier could be addressed by overcoming disparities in HPV- and cervical cancer–related knowledge and perceptions about CCS. Objective: This study aimed to assess the effectiveness of a chatbot-based decision aid to improve women’s participation in the HPVss detection-based CCS care pathway. Methods: AppDate-You is a 2-arm cluster randomized controlled trial (cRCT) nested within the French organized CCS program. Eligible women are those aged 30-65 years who have not been screened for CC for more than 4 years and live in the disadvantaged clusters in the Occitanie Region, France. In total, 32 clusters will be allocated to the intervention and control arms, 16 in each arm (approximately 4000 women). Eligible women living in randomly selected disadvantaged clusters will be identified using the Regional Cancer Screening Coordinating Centre of Occitanie (CRCDC-OC) database. Women in the experimental group will receive screening reminder letters and HPVss kits, combined with access to a chatbot-based decision aid tailored to women with lower education attainment. Women in the control group will receive the reminder letters and HPVss kits (standard of care). The CRCDC-OC database will be used to check trial progress and assess the intervention’s impact. The trial has 2 primary outcomes: (1) the proportion of screening participation within 12 months among women recalled for CCS and (2) the proportion of HPVss-positive women who are “well-managed” as stipulated in the French guidelines. Results: To date, the AppDate-You study group is preparing and developing the chatbot-based decision aid (intervention). The cRCT will be conducted once the decision aid has been completed and validated. Recruitment of women is expected to begin in January 2023. Conclusions: This study is the first to evaluate the impact of a chatbot-based decision aid to promote the CCS program and increase its performance. The study results will inform policy makers and health professionals as well as the research community. Trial Registration: ClinicalTrials.gov NCT05286034; https://clinicaltrials.gov/ct2/show/NCT05286034

Background: Preschoolers’ lifestyles have become physically inactive and sedentary, their eating habits have become unhealthy, and their sleep routines have become increasingly disturbed. Parent-based interventions have shown promise to improve physical activity (PA), improve dietary behavior (DB), and reduce sleep problems among preschoolers. However, because of the recognized obstacles of face-to-face approaches (eg, travel costs and time commitment), easy access and lower costs make eHealth interventions appealing. Previous studies that examined the effectiveness of parent-based eHealth for preschoolers’ PA, DB, and sleep have either emphasized 1 variable or failed to balance PA, DB, and sleep modules and consider the intervention sequence during the intervention period. There is an acknowledged gap in parent-based eHealth interventions that target preschoolers raised in Chinese cultural contexts. Objective: This study aims to investigate the effectiveness of a parent-based eHealth intervention for PA, DB, and sleep problems among Chinese preschoolers. Methods: This 2-arm, parallel, randomized controlled trial comprises a 12-week intervention with a 12-week follow-up. A total of 206 parent-child dyads will be randomized to either an eHealth intervention group or a control group. Participants allocated to the eHealth intervention group will receive 12 interactive modules on PA, DB, and sleep, with each module delivered on a weekly basis to reduce the sequence effect on variable outcomes. The intervention is grounded in social cognitive theory. It will be delivered through social media, where parents can obtain valid and updated educational information, have a social rapport, and interact with other group members and facilitators. Participants in the control group will receive weekly brochures on PA, DB, and sleep recommendations from kindergarten teachers, but they will not receive any interactive components. Data will be collected at baseline, 3 months, and 6 months. The primary outcome will be preschoolers’ PA. The secondary outcomes will be preschoolers’ DB, preschoolers’ sleep duration, preschoolers’ sleep problems, parents’ PA, parenting style, and parental feeding style. Results: Parent-child dyads were recruited in September 2023. Baseline and posttest data collection occurred from October 2023 to March 2024. The follow-up data will be obtained in June 2024. The results of the study are expected to be published in 2025. Conclusions: The parent-based eHealth intervention has the potential to overcome the barriers of face-to-face interventions and will offer a novel approach for promoting a healthy lifestyle among preschoolers. If this intervention is found to be efficacious,

Introduction Peer online mental health forums are commonly used and offer accessible support. Positive and negative impacts have been reported by forum members and moderators, but it is unclear why these impacts occur, for whom and in which forums. This multiple method realist study explores underlying mechanisms to understand how forums work for different people. The findings will inform codesign of best practice guidance and policy tools to enhance the uptake and effectiveness of peer online mental health forums. Methods and analysis In workstream 1, we will conduct a realist synthesis, based on existing literature and interviews with approximately 20 stakeholders, to generate initial programme theories about the impacts of forums on members and moderators and mechanisms driving these. Initial theories that are relevant for forum design and implementation will be prioritised for testing in workstream 2. Workstream 2 is a multiple case study design with mixed methods with several online mental health forums differing in contextual features. Quantitative surveys of forum members, qualitative interviews and Corpus-based Discourse Analysis and Natural Language Processing of forum posts will be used to test and refine programme theories. Final programme theories will be developed through novel triangulation of the data. Workstream 3 will run alongside workstreams 1 and 2. Key stakeholders from participating forums, including members and moderators, will be recruited to a Codesign group. They will inform the study design and materials, refine and prioritise theories, and codesign best policy and practice guidance. Ethics and dissemination Ethical approval was granted by Solihull Research Ethics Committee (IRAS 314029). Findings will be reported in accordance with RAMESES (Realist And MEta-narrative Evidence Syntheses: Evolving Standards) guidelines, published as open access and shared widely, along with codesigned tools. Trial registration number ISRCTN 62469166; the protocol for the realist synthesis in workstream one is prospectively registered at PROSPERO CRD42022352528.

Objective: This study describes a research protocol for a behavioral marker-based predictive model that examines the functional status of older adults with subjective cognitive decline and mild cognitive impairment. Methods: A total of 130 older adults aged ≥65 years with subjective cognitive decline or mild cognitive impairment will be recruited from the Dementia Relief Centers or the Community Service Centers. Data on behavioral and psychosocial markers (e.g. physical activity, mobility, sleep/wake patterns, social interaction, and mild behavioral impairment) will be collected using passive wearable actigraphy, in-person questionnaires, and smartphone-based ecological momentary assessments. Two follow-up assessments will be performed at 12 and 24 months after baseline. Mixed-effect machine learning models: MErf, MEgbm, MEmod, and MEctree, and standard machine learning models without random effects [random forest, gradient boosting machine] will be employed in our analyses to predict functional status over time. Results: The results of this study will be fundamental for developing tailored digital interventions that apply deep learning techniques to behavioral data to predict, identify, and aid in the management of functional decline in older adults with subjective cognitive decline and mild cognitive impairment. These older adults are considered the optimal target population for preventive interventions and will benefit from such tailored strategies. Conclusions: Our study will contribute to the development of self-care interventions that utilize behavioral data and machine learning techniques to provide automated analyses of the functional decline of older adults who are at risk for dementia.

Introduction Living in an area with no or deficient structures for trans health care is disadvantageous for trans people. By providing an internet-based health care programme, i²TransHealth aims at reducing structural disadvantages for trans people living in areas lacking specialised care. The e-health intervention consists of video consultations and a 1:1 chat with a study therapist. Additionally, the i²TransHealth network cooperates with physicians, who especially offer crisis intervention close to the participants’ place of residence. The aim of this study is to evaluate the (cost-)effectiveness of the internet-based health care programme for trans people compared with a control (waiting) group. The following research questions will be examined with a sample of 163 trans people: Does a 4-month treatment with the i²TransHealth internet-based health care programme improve patient-reported health-outcomes? Is i²TransHealth cost-effective compared with standard care from a societal or health care payers’ perspective? Does the participation in and support by i²TransHealth lead to an increase of trans-related expertise in the physician network? Methods and analysis In a randomised controlled trial, the outcomes of an internet-based health care programme for trans people will be investigated. In the intervention group, participants are invited to use i²TransHealth for 4 months. Participants allocated to the control group will be able to start with their transition-related care after 4 months of study participation. The primary outcome measure is defined as the reduction of psychosomatic symptoms, as assessed by the Brief Symptom Inventory-18, 4 months after using the i²TransHealth programme. Participants in both groups will undergo an assessment at baseline and 4 months after using i²TransHealth. Ethics and dissemination Positive ethical approval was obtained from the Hamburg Medical Association (PV7131). The results will be disseminated to service users and their families via media, to health care professionals via professional training and meetings and to researchers via conferences and publications. Trial registration number NCT04290286 . Protocol version 22 December 2021 (V.1.0)

Background: Alcohol use disorder (AUD) is associated with cognitive impairments that are known to affect the outcomes of conventional treatment. Digital cognitive training programs have been examined as a possible way of addressing these overlooked challenges. Existing findings regarding the efficacy of such training programs are divergent, and further studies are warranted to examine more engaging cognitive training programs using the latest technology. Smartphone-based training built upon the principles of serious gaming would not only increase the accessibility of the program, but it could also increase the motivation of the patients, potentially maximizing adherence to the training program. Objective: The aim of the present feasibility and efficacy study was to examine the feasibility and acceptability of the Brain+ Alco-Recover app (Brain+ A/S) with gamified elements among patients with AUD when delivered as an add-on to treatment-as-usual (TAU) and with minimal guidance from health care practitioners. In addition, the effects on cognitive and alcohol-related outcomes were examined. Methods: A total of 72 outpatients were randomized into either group A, experimental + TAU (n=36), or group B, sham + TAU (n=36), and they had to complete a 1-month training program in addition to primary treatment. Self-reported experience at the 6-month follow-up as well as actual game usage was used to determine the feasibility of the training program. Cognitive performance and alcohol consumption were assessed as well. Results: The patients in both groups reported a high level of acceptability, and up to 83% of the patients in the experimental group met the minimum requirements for the usage of the app. The experimental group also demonstrated significant improvements in working memory (P<.001). Although no significant differences were found between the 2 groups regarding clinical outcomes, a greater reduction in alcohol consumption was evident at the 6-month follow-up in the experimental group. Conclusions: The acceptability and adherence to the minimum training requirements deems the gamified Brain+ app as a feasible tool for cognitive training when delivered as an add-on to TAU. Furthermore, the potential improvements in cognitive functions should be further replicated in a larger-scale trial to assess whether these could be used to improve the treatment of AUD in the future.

Background: The diabetes epidemic continues to surge worldwide, demanding urgent and innovative solutions. Digital health interventions, particularly those targeting behavior change, hold promise due to their affordability and scalability. However, research in this field remains in its early stages. Objective: This study aimed to evaluate the effectiveness of PREDIABETEXT (Prediabetes Text Message Digital Intervention for the Prevention of Type 2 Diabetes Mellitus), a digital health intervention, in reducing glycated hemoglobin (HbA1c) and in improving secondary clinical, physiological, and behavioral outcomes. Methods: We conducted a 6-month, 3-arm, pragmatic cluster randomized clinical trial. We recruited patients with prediabetes (HbA1c levels between 6% and 6.4% in the previous 3 months or 2 consecutive fasting plasma glucose measurements of 110-125 mg/dL) registered at primary care centers in the Balearic Islands, Spain. The PREDIABETEXT intervention consisted of 3 personalized SMS text messages per week aimed at supporting lifestyle behavior changes and online training for their primary health care professionals. A total of 58 professionals (clusters) from 16 centers participated in the study and were randomized (1:1:1) to intervention group A (patient SMS text messaging), intervention group B (patient SMS text messaging+health care professional web-based training), or the control group (usual care). Following the 6-month intervention period, we conducted individual qualitative interviews with 8 patients and 7 health care professionals to evaluate their experiences with the intervention in terms of utility, satisfaction, and implementation barriers. Results: In total, 58 health care professionals (clusters) were included, allocated to the control group (n=20, 34%; 119/365, 32.6% patients), intervention group A (SMS text messaging only; n=18, 31%; 106/365, 29% patients), and intervention group B (SMS text messaging+training; n=20, 34%; 140/365, 38.4% patients). The mean age of the patients was 59.79 (SD 9.75) years, and 54.5% (199/365) were female. The results of the intention-to-treat analysis at the 6-month time point showed that intervention A led to a small, nonsignificant reduction in HbA1c levels compared to the control group (β=−0.05, 95% CI −0.21 to 0.10; P=.50), whereas intervention B showed a similar nonsignificant reduction (β=−0.04, 95% CI −0.12 to 0.10; P=.56). No substantial differences were observed in the remaining secondary outcomes. Interviews revealed positive feedback from patients, who appreciated the intervention’s dietary messages and their frequency and practicality. Participants suggested enhancements such as increased personalization, links to recipes, and nursing follow-ups. Health care professionals valued the online training but highlighted time constraints, suggesting shorter or blended formats to improve accessibility. Conclusions: While PREDIABETEXT did not significantly improve HbA1c levels, it demonstrated potential benefits for patient engagement. Further studies involving more intensive interventions are warranted to confirm the clinical impact on diabetes prevention. Trial Registration: ClinicalTrials.gov NCT05110625; https://www.clinicaltrials.gov/study/NCT05110625

Background: Patient-centeredness has become a guiding principle of delivering quality health care. Integrating self-help services in healthcare facilities through collaboration is a vital part of this, also in rehabilitation. Despite increasing efforts to promote patient-centered care in Germany, implementation remains inconsistent, and research on this is particularly limited for rehabilitation. Objective: This study sought to examine the patient-centeredness of rehabilitation clinics, considering the significance of self-help in their internet presence as a central source of patient information. The research objectives are thus to measure and compare the self-help orientation among rehabilitation clinics’ websites to assess which clinic criteria correlate with certain levels of self-help presentation on the clinic websites. Methods: A quantitative content analysis of 400 rehabilitation clinic websites was conducted as a part of the KoReS project (Self-help friendliness and cooperation with self-help among rehabilitation clinics in Germany) that is co-designed, conducted and disseminated in collaboration with public health and patient representatives. Websites were systematically screened using a newly developed 16-criteria coding instrument assessing self-help orientation. A score was formed from these criteria ranging from 0-16 points. Univariate analyses were applied to describe the score distributions. Binomial logistic regression analyses were performed to determine the self-help orientation levels of the websites based on clinic characteristics. Results: Approximately 61% of the clinics scored low on self-help orientation, with the majority (42%) not being self-help oriented at all. Conversely, nearly 40% of the clinic websites demonstrated high self-help orientation, with 7% of them achieving exceptional scores. On average, 4.4 (±4.1) of 16 points were reached and basic self-help orientation criteria were fulfilled by the clinics. Regression analysis revealed clinics covering the indication areas oncology (OR=2.64, P<.05), neurology (OR=2.73, P<.01) or addiction (OR=3.04, P<.001) to significantly predict higher self-help orientation scores. Facility size, sponsorship type and the number of specialist indication areas did not impact the self-help orientation of the websites overall. Conclusions: This is the first analysis measuring the self-help orientation of rehabilitation clinic websites and indicates that it falls short of its potential. The findings suggest that greater emphasis on self-help display and collaboration with self-help in rehabilitation is needed. It can be achieved by using the concept of self-help friendliness, integrating self-help closely into clinic missions and treatment plans and considering the criteria developed in designing clinic websites to increase patient orientation.

Background: The gender gap in time use and its impact on health and well-being are still prevalent. Women work longer hours than men when considering both paid and unpaid (eg, childcare and chores) work, and this gender disparity is particularly visible among parents. Less is known about factors that could potentially mediate or moderate this relationship (eg, work-family conflict and gender role beliefs). Ecological momentary assessment (EMA) allows for the documentation of changes in momentary internal states, such as time use, stress, or mood. It has shown particular validity to measure shorter-term activities (eg, unpaid work) and is thus useful to address gender differences. Objective: The feasibility of the daily EMA surveys in a parent sample will be examined. The associations between time use, well-being, and stress will be examined, along with potential moderating and mediating factors such as gender, gender role beliefs, and work-family conflict. Finally, the act of monitoring one’s own time use, well-being, and stress will be examined in relation to, for example, the quality of life. Methods: We conducted a quasi-experimental, nonrandomized controlled trial with 3 data collection methods, namely, online questionnaires, EMA surveys, and qualitative interviews. The intervention group (n=64) will participate in the online questionnaires and EMA surveys, and a subsample of the intervention group (n=6-17) will also be invited to participate in qualitative interviews. Over a period of 1 week, participants in the intervention group will answer daily EMA surveys (4 times per day). In contrast, the control group (n=17) will only participate in the online questionnaires at baseline and after 1 week. The following constructs were surveyed: sociodemographic background (eg, age, gender, and household composition; baseline questionnaire); mediators and moderators (eg, gender role beliefs and work-family conflict; baseline and follow-up questionnaires); well-being, quality of life, and trait mindfulness (baseline and follow-up questionnaires); momentary activity and well-being, as well as state mindfulness (EMA); and feasibility (baseline and follow-up questionnaires as well as interviews). We anticipate that participants will regard the daily EMA as feasible. Particular daily time-use patterns (eg, high paid and unpaid workload) are expected to be related to lower well-being, higher stress, and health-related quality of life. These associations are expected to be moderated and mediated by factors such as gender, gender role beliefs, work-family conflict, and social support. Participants in the intervention group are expected to show higher values of mindfulness, well-being, health-related quality of life, and lower stress. Results: Patient recruitment started in November 2023 and ended in mid April 2024. Data analysis commenced in mid April 2024. Conclusions: This study aims to provide valuable insights into the feasibility of using EMAs and the potential benefits of activity tracking in various aspects of daily life. Trial Registration: Open Science Framework 8qj3d; https://osf.io/8qj3d

Background Chronic obstructive pulmonary disease (COPD) is a highly prevalent respiratory disease associated with significant health decline and economic burdens. Pulmonary rehabilitation is an effective intervention, but securing adherence to exercise is difficult, particularly for frail and disabled patients, challenged by leaving their home. Home-based exercise is an emerging alternative for persons with COPD, but long-term adherence is unclear. This study aims to investigate the effects, experiences and acceptability of long-term home-based cycling for patients with COPD post exacerbation.

Background: Mood and anxiety disorders are prevalent mental health diagnoses. Numerous studies have shown that measurement-based care, which is used to monitor patient symptoms, functioning, and treatment progress and help guide clinical decisions and collaboration on treatment goals, can improve outcomes in patients with these disorders. Including digital information regarding patients’ electronic communications and social media activity is an innovative approach to augmenting measurement-based care. Recent data indicate interest and willingness from both mental health clinicians and patients to share this type of digital information in treatment sessions. However, the clinical benefit of systematically doing this has been minimally evaluated. Objective: This study aims to develop an electronic dashboard for tracking patients’ digital social activity and a protocol for a pragmatic randomized trial to test the feasibility and efficacy of using the dashboard in real-world clinical care of patients with depression or anxiety disorders. Methods: We developed a personalized electronic dashboard that tracks patients’ electronic communications and social media activity, visualizes data on these interactions through key graphics and figures, and provides a tool that can be readily integrated into routine clinical care for use by clinicians and patients during treatment sessions. We then designed a randomized trial to evaluate the feasibility and effectiveness of using the electronic dashboard in real-world care compared to treatment as usual. The trial included patients aged ≥12 years with a mood or anxiety disorder who were receiving treatment in outpatient psychiatry clinics in the Johns Hopkins Health System and the Kennedy Krieger Institute. The primary outcome includes changes in patient-rated depression symptoms. Secondary outcomes include changes in patient-rated anxiety symptoms and overall functioning. Exploratory analyses examine the impact of the intervention on measures of therapeutic alliance and the detection of clinically actionable targets. Results: We successfully developed an electronic dashboard for tracking patients’ electronic communications and social media activity, and we implemented a protocol for evaluating the feasibility and efficacy of using the dashboard in routine care for mood or anxiety disorders. The protocol was approved by the Johns Hopkins University School of Medicine Institutional Review Board. In this study, we report the technological, ethical, and pragmatic considerations in developing the dashboard and testing it in a real-world setting. Conclusions: The integration of an electronic dashboard to monitor digital social activity in mental health care treatment is novel. This study examines the feasibility and effectiveness of the dashboard and the challenges in implementing this protocol. The lessons learned from developing and implementing the study will inform ongoing discussions about the value of gathering collateral information on patients’ digital social activity and how to do so in a way that is acceptable and clinically effective. Clinical Trial: ClinicalTrials.gov NCT03925038; https://clinicaltrials.gov/study/NCT03925038

Background: There is great potential for delivering cost-effective, quality health care for patients with chronic conditions through digital interventions. Managing chronic conditions often includes a substantial workload required for adhering to the treatment regimen and negative consequences on the patient’s function and well-being. This treatment burden affects adherence to treatment and disease outcomes. Digital interventions can potentially exacerbate the burden but also alleviate it. Objective: The objective of this review is to identify, summarize, and synthesize the evidence of how digital interventions impact the treatment burden of people with chronic conditions. Methods: The search, selection, and data synthesis processes were designed according to the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) 2015. A systematic search was conducted on October 16, 2023, from databases PubMed, Scopus, Web of Science, ACM, PubMed Central, and CINAHL. Results: Preliminary searches have been conducted, and screening has been started. The review is expected to be completed in October 2024. Conclusions: As the number of patients with chronic conditions is increasing, it is essential to design new digital interventions for managing chronic conditions in a way that supports patients with their treatment burden. To the best of our knowledge, the proposed systematic review will be the first review that investigates the impact of digital interventions on the treatment burden of patients. The results of this review will contribute to the field of health informatics regarding knowledge of the treatment burden associated with digital interventions and practical implications for developing better digital health care for patients with chronic conditions.

Introduction Breast cancer is the most prevalent cancer among women. The treatment is extensive; in addition to surgery, various combinations of radiation therapy, chemotherapy and antibody and endocrine treatment can be applied. Cancer-related fatigue (CRF) is high in patients with breast cancer, peaking during chemotherapy, but may persist for several years. Physical activity has proven to be effective in reducing CRF in breast cancer rehabilitation, but many patients tend to be less active after the diagnosis. Yoga has a previously demonstrated effect on energy levels and digitally distributed yoga intervention can potentially increase accessibility in pandemic times and facilitate participation for patients susceptible to infection and those living far from organised rehabilitation opportunities. The purpose of this study, Digital Yoga Intervention in Cancer Rehabilitation (DigiYoga CaRe) is to investigate whether a 12-week digitally distributed yoga intervention can reduce CRF and stress, improve health-related quality of life (HRQL) and affect pro-inflammatory and metabolic markers in patients with breast cancer. Methods and analysis This multicentre study will adopt a randomised controlled design including 240 persons after their breast cancer surgery. They will be randomised to a 12-week digitally distributed yoga intervention or to a control group. The intervention group practice yoga two times a week, one yoga class live-streamed to the patient’s computer or mobile device and one prerecorded video class for self-training. The controls receive standardised care, gift cards for flowers and access to yoga video links after the data collection has ended. The primary analysis will be performed following the principle of intention to treat. Data will be collected by questionnaires, blood samples, accelerometers and interviews. Ethics and dissemination The DigiYoga CaRe study was approved by the Regional Ethical Review Board in Lund. The final results of this study will be disseminated to conference, patient and public involvements and peerreviewed publications. Trial registration number NCT04812652.

Background: Background: Social anxiety disorder (SAD) and agoraphobia are common, impairing conditions often treated with cognitive behavioral therapy (CBT) conducted in groups. In CBT, exposure therapy is a core element. However, in-vivo exposure therapy is logistically challenging and aversive for both patient and therapist, especially in a group context, often leading to exposure being skipped all together in clinical practice. Virtual reality exposure (VRE), in which phobic stimuli is presented through immersive virtual reality technology, has shown promise as a flexible alternative to in-vivo exposure. We thus hypothesized that using VRE would result in more overall exposure and more individualized exposure, resulting in statistically significant symptom reduction compared with a group using in-vivo exposure. Objective: Objectives: This trial evaluated the efficacy of group CBT with VRE (VR-CBT) versus CBT with in-vivo exposure for treating SAD and agoraphobia in clinical settings. Methods: Methods: In this randomized, parallel-group, assessor-blinded trial, 177 participants with SAD (N =150) or agoraphobia (N=27) as a primary diagnosis were assigned to either VR-CBT (N =81) or traditional CBT (N=96) across five Danish mental health outpatient clinics. Both groups received 14 weekly group sessions. The difference between the two treatments was, that the VR-CBT group received exposure therapy via head-mounted displays (HMDs) displaying 360-degree videos of anxiogenic situations for individuals with SAD (E.g., presenting at work) and agoraphobia (E.g., faulty elevator), while the CBT group conducted traditional in-vivo exposure exercises (E.g., presenting to the group, using the clinic elevator). Primary outcomes were phobic anxiety reductions, measured by the Liebowitz Social Anxiety Scale (LSAS) and the Mobility Inventory for Agoraphobia (MIA) at baseline, post-treatment, and 1 year-follow up (from baseline). Secondary outcomes included work and social functioning, depressive symptoms, and quality of life. Results: Results: Both groups showed significant reductions in primary, secondary, and exploratory outcomes, with no significant differences between groups at post-treatment (d= -0.026) and 1 year follow-up (d=0.097). Baseline characteristics and attrition rates were balanced across groups. Conclusions: Conclusion: Due to insufficient recruitment and substantial missing data, no definitive conclusions can be drawn regarding group differences between VR-CBT and traditional CBT in group settings. The feasibility issues encountered suggest that careful consideration of the benefits and limitations of VR technology is essential before implementation in clinical practice. Clinical Trial: Clinicaltrials.gov NCT03845101; https://clinicaltrials.gov/study/NCT03845101?term=NCT03845101&rank=1

Mobile monitoring of outpatients during cancer therapy becomes possible through technological advancements. This study leveraged a new remote patient monitoring app for in-between systemic therapy sessions. Patients' evaluation showed that the handling is feasible. Clinical implementation must consider an adaptive development cycle for reliable operations.

Background: There is sound evidence associating high salt intake and a greater risk of cardiovascular and noncardiovascular diseases. High salt intake has been observed in several populations worldwide. Therefore, promoting healthier salt consumption has been encouraged as a low-cost strategy to reduce this risk factor. However, these strategies need to be sound, built on theoretical and methodological bases, and consider the target population’s context. Objective: This protocol aims to describe a mobile phone app intervention to promote healthy salt intake among adults. Methods: This is an experimental and longitudinal study protocol conducted in three modules. Module 1 refers to the planning of the intervention based on the Behaviour Change Wheel framework. Module 2 is the development of the mobile phone app intervention based on the date of module 1. In module 3, the intervention will be evaluated using a randomized controlled study, with three steps of data collection in a 2-month follow-up in a sample of 86 adults (43 participants for each group: the control group and intervention group) recruited from the primary health care centers of a Brazilian town. The discretionary salt intake questionnaire will assess salt consumption, the app usability will be assessed using the System Usability Scale, and psychosocial variables (habit, intention, and self-efficacy) will also be measured. Results: Recruitment began in October 2021, and the follow-up will end in August 2022. The results of this study are expected to be published in 2023. Conclusions: Results from this study will help people to control salt intake when cooking at home, will stimulate self-care, will work as an alternative or supportive method in the relationship between health care professionals and patients, and will contribute to implementing the app intervention to promote healthy salt intake on a large scale. Trial Registration: The Brazilian Clinical Trials Registry RBR-4s8qyyq; https://ensaiosclinicos.gov.br/rg/RBR-4s8qyyq