Background: The protocol in this manuscript was designed to help graduate students publish, which resulted from a challenge from our provost in 2013. I developed this protocol over the last 6 years and have exercised the protocol for the last 5 years. The current version of the protocol has remained mostly static for the last 2 years—only small changes have been made to the process. Objective: The objective of this protocol is to enable students to learn a valuable skill of conducting a systematic review and to write the review in a way that can be published. I have designed the protocol to fit into the schedule of a traditional semester, but also used it in compressed semesters. Methods: An image map was created in HTML 5.0 and imported into a learning management system. It augments traditional instruction by providing references to published articles, examples, and previously recorded instructional videos. Students use the image map outside the classroom after traditional instruction. The image map helps students create manuscripts that follow established practice and are reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), and whose authorship follows guidelines by the International Committee of Medical Journal Editors. Results: Since its inception, this protocol has helped 77 students publish 27 systematic reviews in nine journals worldwide. Some manuscripts take multiple years to progress through multiple review processes at multiple journals submitted in sequence. Two other professors in the School of Health Administration have used this protocol in their classes. Conclusions: So far, this method has helped 51% of graduate students who used it in my graduate courses publish articles (with more manuscripts under consideration whose numbers have remained uncounted in this sum). I wish success to others who might use this protocol.

Background: Investing in mental well-being is considered a supplement to current mental health service delivery in which the treatment and prevention of mental disorders are core components. It may be possible for people to enhance their well-being by boosting their “mental fitness.” Objective: Psyfit, an online, multi-component, fully automated self-help intervention, was developed with the aim of improving well-being and reducing depressive symptoms. The efficacy and cost-effectiveness of this intervention will be examined in a randomized controlled trial. Methods: In this two-armed randomized controlled trial, a total of 290 participants will be assigned to use Psyfit (experimental condition) or to a 6-month waiting list (control condition). Adults with mild to moderate depressive symptoms interested in improving their mental fitness will be recruited from the general population through advertisements on the Internet and in newspapers. Online measurements by self-assessment will be made prior to randomization (pre-test), 2 months after baseline (post-test), and 6 months after baseline (follow-up). Results: The primary outcome is well-being. Secondary outcomes are depressive symptoms, general health, vitality, and economic costs. Analysis will be conducted in accordance with the intention-to-treat principle. Conclusions: This study will examine the efficacy and cost-effectiveness of an online intervention that aims to promote well-being in people with elevated levels of depressive symptoms. If shown to be effective, the intervention could prove to be an affordable and widely accessible intervention to improve well-being in the general population.

Background: Physiological and environmental risk factors interact to undermine blood glucose control during early adolescence. This has been documented to be associated with family conflict and poor adherence to diabetes management tasks. Family Teamwork is an efficacious program demonstrated to enhance family communication and reduce conflict during this vulnerable period. It was designed to be delivered to families in-person, which limited reach and potential impact. Objective: The purpose of this paper is to present the protocol for adapting Family Teamwork for Web-based delivery. Methods: Formative research with health care providers, parents, and adolescents will help modify Family Teamwork for Web-based delivery by a relational agent (ie, a computerized character with human-like features and actions). Sessions will be interactive, requiring both parent and adolescent participation, with the relational agent serving as a health coach. After programming, usability testing will be conducted to help ensure the program is easy to use. Video and instructional materials will be developed to facilitate use, and a small pilot study will be conducted to assess feasibility. Families will provide written informed consent prior to participation in any phase of the study. The Institutional Review Board at Baylor College of Medicine reviewed and approved the protocol (H-37245). Results: Formative research is underway. No results are available at this time. Conclusions: This research has the potential to make an important contribution to diabetes management by using technology to enhance the reach of an efficacious program.

Background: The decline in the uptake of routine childhood vaccinations has resulted in outbreaks of vaccine-preventable diseases. Vaccination apps can be used as a tool to promote immunization through the provision of reminders, dissemination of information, peer support, and feedback. Objective: The aim of this review is to systematically review the evidence on the use of apps to support childhood vaccination uptake, information storage, and record sharing. Methods: We will identify relevant papers by searching the following electronic databases: PubMed, Embase by Ovid, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov, and Education Resources Information Center (ERIC). We will review the reference lists of those studies that we include to identify relevant additional papers not initially identified using our search strategy. In addition to the use of electronic databases, we will search for grey literature on the topic. The search strategy will include only terms relating to or describing the intervention, which is app use. As almost all titles and abstracts are in English, 100% of these will be reviewed, but retrieval will be confined to papers written in the English language. We will record the search outcome on a specifically designed record sheet. Two reviewers will select observational and intervention studies, appraise the quality of the studies, and extract the relevant data. All studies will involve the use of apps relating to child vaccinations. The primary outcome is the uptake of vaccinations. Secondary outcomes are as follows: (1) use of app for sharing of information and providing vaccination reminders and (2) use of app for storage of vaccination information; knowledge and decision making by parents regarding vaccination (ie, risks and benefits of vaccination); costs and cost-effectiveness of vaccination apps; use of the app and measures of usability (eg, usefulness, acceptability, and experiences of different users: parents and health care professionals); use of technical standards for development of the app; and adverse events (eg, data leaks and misinformation). We will exclude studies that do not study an app. We anticipate a limited scope for meta-analysis and will provide a narrative overview of findings and tabular summaries of extracted data. Results: This project was funded by the Sir David Cooksey Fellowship in Healthcare Translation at the University of Oxford, Oxford, United Kingdom. We will submit the full systematic review for publication in the Journal of Medical Internet Research. Conclusions: This review will follow, where possible, the Cochrane Collaboration and the Centre for Review and Dissemination methodologies for conducting systematic reviews. We will report our findings based on guidelines from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The review results will be used to inform the development of a vaccination app.

Background: Hypertension (HTN) is a major public health concern in the United States given its wide prevalence, high cost, and poor rates of control. Multiple strategies to counter this growing epidemic have been studied, and home blood pressure (BP) monitoring, mobile health (mHealth) interventions, and referrals to clinical pharmacists for BP management have all shown potential to be effective intervention strategies. Objective: The purpose of this study is to establish feasibility and acceptability of BPTrack, a clinical pharmacist-led mHealth intervention that aims to improve BP control by supporting home BP monitoring and medication adherence among patients with uncontrolled HTN. BPTrack is an intervention that makes home-monitored BP data available to clinical pharmacists for use in HTN management. Secondarily, this study seeks to understand barriers to adoption of this intervention, as well as points of improvement among key stakeholders, so that larger scale dissemination of the intervention may be achieved and more rigorous research can be conducted. Methods: This study is recruiting up to 25 individuals who have poorly controlled HTN from a Family Medicine clinic affiliated with a large Midwestern academic medical center. Patient participants complete a baseline visit, including installation and instructions on how to use BPTrack. Patient participants are then asked to follow the BP monitoring protocol for a period of 12 weeks, and subsequently complete a follow-up visit at the conclusion of the study period. Results: The recruitment period for the pilot study began in November 2016, and data collection is expected to conclude in late-2017. Conclusions: This pilot study seeks to document the feasibility and acceptability of a clinical pharmacist-led mHealth approach to managing HTN within a primary care setting. Through our 12-week pilot study, we expect to lend support for this approach, and lay the foundation for translating this approach into wider-scale implementation. This mHealth intervention seeks to leverage the multidisciplinary care team already in place within primary care, and to improve health outcomes for patients with uncontrolled HTN.

Background There is an increasing prevalence of mental health problems among university student populations. In Indonesia, treatment rates are low among university students because of the high cost of treatment, stigma and the limited availability of mental care services. Internet-based interventions have been found to be effective in treating anxiety and depression in Western countries. However, little is known about the effectiveness of Internet-based interventions in low- and middle-income countries (LMICs) such as Indonesia. In this paper, we describe how we culturally adapted an Internet-based intervention to meet the needs of Indonesian students with depression and anxiety based on the theoretical framework of Barrera et al. (2013). Method We culturally adapted a Western Internet-based student intervention for depression and anxiety. This intervention consists of 8 guided online sessions. 50 students from Universitas Gadjah Mada Yogyakarta who have mild to moderate depression or anxiety as assessed with the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7), will participate in a feasibility study in which we will test participants' satisfaction, system usability and uptake. Secondary outcomes include assessment of participants' depression, anxiety and quality of life. Outcomes will be measured pre and post intervention. Discussion The present paper presents the protocol of a pilot study aimed at assessing the feasibility and acceptability of a culturally adapted intervention for Indonesian university students with depression and anxiety. The results from the feasibility study will further guide the development of the intervention and may inform the protocol of a future randomized controlled trial (RCT) examining the effectiveness of the Internet-based intervention.

Introduction For the optimal management of children with cystic fibrosis, there are currently no efficient tools for the precise adjustment of pancreatic enzyme replacement therapy, either for advice on appropriate dietary intake or for achieving an optimal nutrition status. Therefore, we aim to develop a mobile application that ensures a successful nutritional therapy in children with cystic fibrosis. Methods and analysis A multidisciplinary team of 12 partners coordinate their efforts in 9 work packages that cover the entire so-called ‘from laboratory to market’ approach by means of an original and innovative co-design process. A cohort of 200 patients with cystic fibrosis aged 1–17 years are enrolled. We will develop an innovative, clinically tested mobile health application for patients and health professionals involved in cystic fibrosis management. The mobile application integrates the research knowledge and innovative tools for maximising self-management with the aim of leading to a better nutritional status, quality of life and disease prognosis. Bringing together different and complementary areas of knowledge is fundamental for tackling complex challenges in disease treatment, such as optimal nutrition and pancreatic enzyme replacement therapy in cystic fibrosis. Patients are expected to benefit the most from the outcomes of this innovative project. Ethics and dissemination The project is approved by the Ethics Committee of the coordinating organisation, Hospital Universitari La Fe (Ref: 2014/0484). Scientific findings will be disseminated via journals and conferences addressed to clinicians, food scientists, information and communications technology experts and patients. The specific dissemination working group within the project will address the wide audience communication through the website (<http://www.mycyfapp.eu>), the social networks and the newsletter.

Background: Seventy percent of lifetime cases of mental illness emerge prior to age 24. While early detection and intervention can address approximately 70% of child and youth cases of mental health concerns, the majority of youth with mental health concerns do not receive the services they need. Objective: The objective of this paper is to describe the protocol for optimizing and evaluating Thought Spot, a Web- and mobile-based platform cocreated with end users that is designed to improve the ability of students to access mental health and substance use services. Methods: This project will be conducted in 2 distinct phases, which will aim to (1) optimize the existing Thought Spot electronic health/mobile health intervention through youth engagement, and (2) evaluate the impact of Thought Spot on self-efficacy for mental health help-seeking and health literacy among university and college students. Phase 1 will utilize participatory action research and participatory design research to cocreate and coproduce solutions with members of our target audience. Phase 2 will consist of a randomized controlled trial to test the hypothesis that the Thought Spot intervention will show improvements in intentions for, and self-efficacy in, help-seeking for mental health concerns. Results: We anticipate that enhancements will include (1) user analytics and feedback mechanisms, (2) peer mentorship and/or coaching functionality, (3) crowd-sourcing and data hygiene, and (4) integration of evidence-based consumer health and research information. Conclusions: This protocol outlines the important next steps in understanding the impact of the Thought Spot platform on the behavior of postsecondary, transition-aged youth students when they seek information and services related to mental health and substance use.

Background: Over one-third of cancer patients experience clinically significant mental distress, and distress in caregivers can exceed that of the cancer patients for whom they care. There is an urgent need to identify scalable and cost-efficient ways of delivering mental health interventions to cancer patients and their loved ones. Objective: The aim of this study is to describe the protocol to pilot a mobile app–based mental health intervention in breast cancer patients and caregivers. Methods: The IntelliCare mental health apps are grounded in evidence-based research in psychology. They have not been examined in cancer populations. This pilot study will adopt a within-subject, pre-post study design to inform a potential phase III randomized controlled trial. A target sample of 50 individuals (with roughly equal numbers of patients and caregivers) at least 18 years of age and fluent in English will be recruited at a US National Cancer Institute designated clinical cancer center. Consent will be obtained in writing and a mobile phone will be provided if needed. Self-report surveys assessing mental health outcomes will be administered at a baseline session and after a 7-week intervention. Before using the apps, participants will receive a 30-min coaching call to explain their purpose and function. A 10-min coaching call 3 weeks later will check on user progress and address questions or barriers to use. Self-report and semistructured interviews with participants at the end of the study period will focus on user experience and suggestions for improving the apps and coaching in future studies. Results: This study is ongoing, and recruitment will be completed by the end of 2018. Conclusions: Results from this study will inform how scalable mobile phone-delivered programs can be used to support breast cancer patients and their loved ones. Trial Registration: ClinicalTrials.gov NCT03488745; https://clinicaltrials.gov/ct2/show/NCT03488745 International Registered Report Identifier (IRRID): DERR1-10.2196/11452

Background: Type 2 diabetes is common, on the rise, and disproportionately affects ethnic minority groups. Telehealth interventions may mitigate diabetes-related complications, but might under-recruit or even exclude ethnic minorities, in part because of English language requirements. The under-representation of minority patients in trials could threaten the generalizability of the findings, whereby the patients who might stand to benefit most from such interventions are not being included in their evaluation. Objective: The aims of this systematic review are twofold: (1) to assess the reporting and prevalence of ethnic minorities in published telehealth trials for type 2 diabetes, including identifying trial features associated with successful patient recruitment; and (2) to determine the proportion of such trials that report English language proficiency as an inclusion/exclusion criterion, including how and why they do so. Methods: Randomized controlled trials (RCTs) of adults with type 2 diabetes in Western, English-speaking countries that included telehealth interventions targeting diabetes as a primary condition, and those that did not specifically recruit minority groups will be included. Search strategies were devised for indexed and keyword terms capturing type 2 diabetes, telehealth/health technology, and RCTs in English language publications from 2000 to July 2015 in MEDLINE, PsycINFO, EMBASE, CINAHL, and CENTRAL. Reference lists of included studies will also be searched. Two reviewers will independently screen abstracts and full-text articles against inclusion criteria, mediated by a third reviewer if consensus cannot be reached. Data extracted from included studies will be checked by a second reviewer and will be summarized using narrative synthesis. Results: This research is in progress, with findings expected by Spring 2016. Conclusions: This review will address research reporting and recruitment practices of ethnic minorities in telehealth RCTs for type 2 diabetes. Prevalence estimates will elucidate generalizability of existing research, with implications for researchers, health professionals, and policy makers. Identifying trial or intervention features that appear to facilitate ethnic minority recruitment, as well as language barriers that impede it might suggest ways to improve recruitment in future trials.

Cigarette smoking is much more prevalent among young people experiencing homelessness than in the general population of adolescents and young adults. Although many young homeless smokers are motivated to quit, there are no empirically-evaluated smoking cessation programs for this population. It is important that any such program address the factors known to be associated with quitting-related outcomes among homeless young people, to provide ongoing support in a way that accommodates the mobility of this population, and does not rely on scarce service provider resources for its delivery. The objective of this project is to develop and pilot test a text messaging-based intervention (TMI), as an adjunct to brief cessation counseling and provision of nicotine patches, to help homeless young people who want to quit smoking.

Background: Depression is an often underdiagnosed and, therefore, untreated comorbidity for low-income, racially or ethnically diverse patients with a chronic illness such as diabetes. Recent updates from the US Preventive Services Task Force guidelines in 2016 recommend depression screening for every adult but does not suggest the mode of assessment. Short message service (SMS) text messaging is an inexpensive, private, and scalable approach to provide depression screening and monitoring; it can also alleviate many barriers, such as transportation, childcare, and clinical visit time faced by the low-income population, in receiving a diagnosis of depression. Current evidence is inconsistent in comparing technology-mediated assessment versus interviewer (INTW) assessment in collecting sensitive health information, as some studies suggest that technology encourages self-disclosure while the other studies show the opposite effect. Objective: The proposed study will test the use of SMS text messaging to assess depression and its related conditions, including functional disability, pain, and anxiety, in low-income, culturally diverse, safety-net primary care populations with diabetes. The study will examine the concordance between SMS text message and interviewer assessments and evaluate test-retest reliability. Methods: The proposed study will adopt a randomized design with 200 patients assigned to four study groups: SMS/INTW, INTW/SMS, SMS/SMS, and INTW/INTW. The first two groups will be used to examine the concordance between SMS text message and interviewer assessments. The third and fourth groups will be used to evaluate test-retest reliability. Participants of the study will be recruited from the participants of the prior Diabetes-Depression Care-management Adoption Trial, a large comparative effectiveness research trial in collaboration with the Los Angeles County Department of Health Services. Test-retest reliability and concordance between SMS text message and interviewer assessments will be evaluated by the interclass correlation coefficient and the kappa statistic. Missing data patterns will be explored to understand whether participants are willing to self-disclose information related to depression in SMS text message assessments. Results: Recruitment of participants was conducted from June 2017 to November 2017. A total of 206 participants were enrolled: 52 (25.2%) in SMS/INTW, 53 (25.7%) in SMS/SMS, 49 (23.8%) in INTW/SMS, and 52 (25.2%) in INTW/INTW. The average age of the participants was 57.1 years (SD 9.2). A total of 57.8% (119/206) of participants were female, 93.2% (192/206) were Latino, and 77.7% (160/206) chose Spanish as their preferred language. Analysis of the SMS text message assessment shows the cost of distributing the 16 questions is about US $0.50 per person per assessment. Full results of the study will be reported elsewhere. Conclusions: This study is anticipated to establish the feasibility of using SMS text messaging to assess depression and its related conditions in low-income, culturally diverse, safety-net primary care populations with diabetes. We also expect to generate

Background: Electronic health (eHealth) is a multidisciplinary and rapidly evolving field, and thus requires research focused on knowledge accumulation, curation, and translation. Cardiovascular diseases constitute a global health care crisis in which eHealth can provide novel solutions to improve the efficiency and reach of self-management support for patients where they most need it: their homes and communities. A holistic understanding of eHealth projects focused on such case is required to bridge the multidisciplinary gap formed by the wide range of aims and approaches taken by the various disciplines involved. Objective: The primary objective of this review is to facilitate a holistic interpretation of eHealth projects aimed at providing self-management support of cardiovascular diseases in the natural setting of patients, thus priming the use of remote monitoring technologies. The review aims to synthesize the operationalization of frameworks, models, and theories applied to the research and development process of eHealth. Methods: We will use Noblit and Hare’s metaethnography approach to review and synthesize researchers’ and practitioners’ reports on how they applied frameworks, models, and theories in their projects. We will systematically search the literature in 7 databases: Scopus, Web of Science, EMBASE, CINAHL, PsycINFO, ACM Digital Library, and the Cochrane Library. We will thoroughly read and code selected studies to extract both raw and contextual data for the synthesis. The relation of the studies will be determined according to the elements of the frameworks, models, or theories the studies applied. We will translate these elements between each other and intend to synthesize holistic principles for eHealth development for the case at hand. Results: The search strategy has been completed, data extraction is almost finalized, and the first synthesis approaches are underway. The search yielded 1224 citations and, after we applied the selection criteria, 17 articles remained. We expect to submit the final results for publication in 2019. Conclusions: This review is important because it aims to create a holistic understanding of a multidisciplinary topic at the crossroads of eHealth, cardiovascular diseases, and self-management. The value of metaethnography in contrast to other systematic review methods is that its synthesis approach seeks to generate a new understanding of a topic, while preserving the social and theoretical contexts in which findings emerge. Our results will show how useful this method can be in bridging the multidisciplinary gap of eHealth research and development, to inform and advance the importance of holistic approaches, while showcasing this approach for the case of self-management in cardiovascular diseases. Trial Registration: PROSPERO CRD42018104397; https://www.crd.york.ac.uk/PROSPERO/display_record.php? RecordID=104397 (Archived by WebCite at http://www.webcitation.org/75H1kP1Mm) International Registered Report Identifier (IRRID): DERR1-10.2196/13334

Background: Stigma in chronic disease involves unwarranted rejection, judgement, or exclusion by others based on the chronic disease itself. Objective: We aim to determine the prevalence of stigma among youth and young adults with type 1 diabetes in Canada, to assess associations between stigma and glycemic control, and to explore ways to address stigma related to type 1 diabetes. Methods: The study includes 3 distinct phases: (1) refinement of survey questions, (2) assessment of test-retest reliability, and (3) a data collection and analysis phase (online survey and mailed-in capillary blood sample to assess hemoglobin A1c). A total of 380 youth and young adults (14 to 24 years old) with type 1 diabetes are being recruited through social media and clinic posters. Results: Phases 1 and 2 are complete, and phase 3 is in progress. Thirty participants completed phase 2. The survey includes the Barriers to Diabetes Adherence in adolescent scale (intraclass correlation [ICC]=0.967, 95% CI 0.931-0.984), the Self-Efficacy for Diabetes Self-Management measure (ICC=0.952, 95% CI 0.899-0.977), the World Health Organization-5 Well-Being Index (ICC=0.860, 95% CI 0.705-0.933), 12 closed-ended questions, and an additional 5 open-ended questions to explore challenges and solutions developed by the team of experts, including a patient representative. Conclusions: This will be the first large-scale survey to estimate the prevalence of stigma in young people with type 1 diabetes. The results of this study will allow for an appreciation of the magnitude of the problem and the need for developing and implementing solutions. This work is intended to provide an initial understanding of youth perspectives on the challenges of living with type 1 diabetes and will serve as a foundation for future research and action to help youth improve their experience of living with diabetes.

Background: Schizophrenia is a high-cost, chronic, serious mental illness. There is a clear need to improve treatments and expand access to care for persons with schizophrenia, but simple, tailored interventions are missing. Objective: To evaluate the impact of tailored mobile telephone text messages to encourage adherence to medication and to follow up with people with psychosis at 12 months. Methods: Mobile.Net is a pragmatic randomized trial with inpatient psychiatric wards allocated to two parallel arms. The trial will include 24 sites and 45 psychiatric hospital wards providing inpatient care in Finland. The participants will be adult patients aged 18&#8211;65 years, of either sex, with antipsychotic medication (Anatomical Therapeutic Chemical classification 2011) on discharge from a psychiatric hospital, who have a mobile phone, are able to use the Finnish language, and are able to give written informed consent to participate in the study. The intervention group will receive semiautomatic system (short message service [SMS]) messages after they have been discharged from the psychiatric hospital. Patients will choose the form, content, timing, and frequency of the SMS messages related to their medication, keeping appointments, and other daily care. SMS messages will continue to the end of the study period (12 months) or until participants no longer want to receive the messages. Patients will be encouraged to contact researchers if they feel that they need to adjust the message in any way. At all times, both groups will receive usual care at the discretion of their team (psychiatry and nursing). The primary outcomes are service use and healthy days by 12 months based on routine data (admission to a psychiatric hospital, time to next hospitalization, time in hospital during this year, and healthy days). The secondary outcomes are service use, coercive measures, medication, adverse events, satisfaction with care, the intervention, and the trial, social functioning, and economic factors. Data will be collected 12 months after baseline. The outcomes are based on the national health registers and patients&#8217; subjective evaluations. The primary analysis will be by intention-to-treat. Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN): 27704027; http://www.controlled-trials.com/ISRCTN27704027 (Archived by WebCite at http://www.webcitation.org/69FkM4vcq)

Background: There is worldwide recognition that the future provision of health care requires a reorganization of provision of care, with increased empowerment and engagement of patients, along with skilled health professionals delivering services that are coordinated across sectors and organizations that provide health care. Technology may be a way to enable the creation of a coherent, cocreative, person-centered method to provide health care for individuals with one or more long-term conditions (LTCs). It remains to be determined how a new care model can be introduced that supports the intentions of the World Health Organization (WHO) to have integrated people-centered care.

Background: Depression is a global health challenge. Prevention is highlighted as a priority to reduce its prevalence. Although effective preventive interventions exist, the efficacy and coverage can be improved. One proposed means to increase efficacy is by using interventions to target specific risk factors, such as rumination. Rumination-focused CBT (RFCBT) was developed to specifically target depressive rumination and reduces acute depressive symptoms and relapse for patients with residual depression in a randomised controlled trial. Preliminary findings from a Dutch randomised prevention trial in 251 high-risk 15- to 22-year-old subjects selected with elevated worry and rumination found that both supported internet-RFBCT and group-delivered RFCBT equally reduced depressive symptoms and the onset of depressive cases over a period of 1 year, relative to the no-intervention control.

Discussion: If FITNET-NHS is found to be feasible and acceptable (internal pilot) and effective and cost-effective (full trial), its provision by the NHS has the potential to deliver substantial health gains for the large number of young people suffering from CFS/ME but unable to access treatment because there is no local specialist service. This trial will provide further evidence evaluating the delivery of online CBT to young people with chronic conditions. Trial registration: ISRCTN registry, registration number: ISRCTN18020851. Registered on 4 August 2016.

Background: It is often only when the initial signs of exhaustion appear that caregivers first may engage in help-seeking behavior, but it is difficult for them to know which is the most appropriate formal service in their situation. Electronic health (eHealth) can support caregivers in keeping the older person they are caring for at home, but few eHealth tools designed for supporting the process of help-seeking by caregivers of functionally impaired older persons have been developed using a co-design approach. Objective: This paper aims to describe the protocol of a project that tries to assist caregivers to target their needs and those of the older person they support early in their help-seeking process, and guide them effectively to the formal service most appropriate for their situation. This project aims to answer the following questions: (1) What type of tool can better support caregivers to identify their needs and those of the older person they are caring for and then refer them to an appropriate formal service? and (2) What information should be found in such a tool? Methods: This study presents a description of the process of an ongoing multicenter research project based on a co-design approach, which includes 3 phases (1) identification of caregivers’ needs in terms of tools to support their help-seeking behavior, (2) development of a tool, and (3) evaluation of its usability. Results: The project began in January 2016 with the ethics application for the 3 phases of the project. For phase 1, recruitment began in December 2016 and ended in September 2017. Phase 2 began in the spring of 2017 and ended in June 2018. All the co-design sessions have been completed. Phase 3 of the project will begin in September 2018. Conclusions: Although there are some challenges associated with this type of methodology, the methodology still remains relevant, as it involves future users in the development of a tool, which increases the chances that the tool will meet the users' needs. International Registered Report Identifier (IRRID): DERR1-10.2196/11634

Background: Patient portals are digital health tools adopted by health care organizations. The portals are generally connected to the electronic health record of the health care organization and offer patients functionalities such as access to the medical record, ability to order repeat prescriptions, make appointments, or message the health care provider. Patient portals may be beneficial for both patients and the health care system. Patient portals can widely differ from one context to another due to the differences in the portal functionalities and capabilities and it is anticipated that outcomes associated with the functionalities also differ. Current systematic reviews report outcomes associated with patient portal uptake but do not explicitly specify the patient portal functionalities. Objective: The aim of this systematic review is to synthesize the evidence on health and health care quality outcomes associated with patient portal use among adult (18 years or older) patients. The review research questions are as follows: What kind of health outcomes do tethered patient portals and patient portal functionalities contribute to in adult patients (18 years or older)? and What kind of health care quality outcomes, including health care utilization outcomes, do tethered patient portals and patient portal functionalities contribute to in adult patients (18 years or older)? Methods: The systematic review will be conducted by searching the MEDLINE, EMBASE, and Scopus databases for relevant literature. The review inclusion criteria will be studies about adult patients (18 years or older), studies only about tethered patient portals, and studies with or without a comparator. We will report patient portal–associated health and health care quality outcomes based on the patient portal functionalities. All quantitative primary study types will be included. Risk of bias of included studies will be assessed using the Cochrane Collaboration’s tool for assessing risk of bias in randomized trials and the National Heart, Lung, and Blood Institute’s quality assessment tools. Data will be synthesized using narrative synthesis and will be reported according to the patient portal functionalities, country, disease, and health care system model. Results: Searches will be conducted in September 2019, and the review is anticipated to be completed by the end of June 2020. Conclusions: This systematic review will provide an overview of health and health care quality outcomes associated with patient portal use among adult patients, providing detailed information about the functionalities of the portals and their associations with the outcomes. The review could potentially help patient portal evaluation studies by providing insights into outcomes associated with the different functionalities of patient portals.

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&#180; 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&#8212;before, immediately after, and 6 months after the intervention. Subjects&#180; 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&#180; knowledge on insulin therapy and potentially improving DM patients&#180; 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 &gt;18 years with cardiac pain or associated symptoms lasting &gt;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 &gt;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&lt;.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.