: Excess weight is a major risk factor for chronic diseases. In Australia, over 60% of adults are overweight or obese. The overconsumption of energy-dense nutrient-poor (EDNP) foods and low physical activity (PA) levels are key factors contributing to population obesity. New cost-effective approaches to improve population diet and PA behaviors are needed. : This 1-year randomized controlled trial (6-month intervention and 6-month follow-up) aims to investigate whether a tailored intervention using mobile technology can improve diet and PA behaviors leading to weight loss in adults (aged 18-65 years) who are overweight or obese and recruited through a social marketing campaign (LiveLighter). : All eligible participants will provide data on demographics and lifestyle behaviors online at baseline, 6 months, and 12 months. Using two-stage randomization, participants will be allocated into one of three conditions (n=200 per group): tailored feedback delivered via email at seven time points, informed by objective dietary (mobile food record app) and activity (wearable activity monitor) assessment; active control receiving no tailored feedback, but undergoing the same objective assessments as tailored feedback; and online control receiving no tailored feedback or objective assessments. Primary outcome measures at 6 and 12 months are changes in body mass, EDNP food and beverage consumption, and daily moderate-to-vigorous PA (measured via accelerometry). Secondary outcomes include change in fruit and vegetable consumption, daily sedentary behaviors, and cost effectiveness. : Enrolment commenced in August 2017. Primary outcomes at 12 months will be available for analysis from September 2019. : Tailored email feedback provided to individuals may deliver a cost-effective strategy to overcome existing barriers to improving diet and PA. If found to be successful and cost effective, upscaling this intervention for inclusion in larger-scale interventions is highly feasible. : Australian New Zealand Clinical Trials Registry ACTRN12617000554369; https://www.anzctr.org.au /Trial/Registration/TrialReview.aspx?id=371325&isReview=true

Background: The skin is a dynamic ecosystem of microbes and the source of many chemical compounds that affect human health. Skin-microbiome interactions can cause persistent, psychosocially devastating body smell despite good hygiene. Since odor production is often transient, malodors may not be perceptible during medical examinations. Therefore, having odor complaints can be diagnosed as body dysmorphic disorder and referred for psychological evaluations. Development of simple at-home tests and virtual care programs could improve the diagnosis and management of socially debilitating malodor conditions. Objective: The aim of this study was to assess potential effectiveness of at-home gut microbiome testing in the diagnosis and management of idiopathic body and breath odor and in people are allergic to me (PATM) syndrome. Methods: We contacted participants of prior metabolic body odor (MEBO) and PATM studies and online support groups by email or social media. Individuals who consented to participate were mailed test kits for at-home collection of gut microbiome samples. Participants completed an online survey (specially developed for this study) addressing their symptoms and other quality-of-life indicators at baseline and after sampling. Participants collected stool samples after flare-ups or symptom improvements and mailed them to the laboratory to be processed and analyzed. We evaluated between-group differences in symptom severity, as well as symptom improvement observations for the same individuals. For differential abundance testing of microbial taxa, we performed nonparametric statistical analyses using Mann-Whitney U tests for unpaired samples and Wilcoxon signed rank test for paired samples. Results: A total of 112 individuals from 21 countries consented to participate. About half the participants had been tested for the metabolic disorder trimethylaminuria, and about half of those tested were diagnosed with the disorder. The levels of bacteria previously associated with cutaneous body odor were significantly elevated in gut samples. For the combination of species from Anaerococcus, Corynebacterium, Campylobacter, and Propionibacterium genera, the differences were P=.002 for active (73 participants, 182 samples) versus regression or remission groups (30 participants, 51 samples); P=.01 for those experiencing symptoms most or all of the time (46 participants, 88 samples) versus those who had symptoms sometimes, rarely, or never (25 participants, 74 samples); and P<.001 for improvement of symptoms in the same individuals (22 participants, 43 sets of matched samples). Changes in microbial diversity were significant for between- but not within-participant comparisons. Conclusions: Changes in the gut microbiome composition affect MEBO and PATM severity. In particular, an increase in intestinal bacteria producing odor when in skin flexures was associated with increased intensity of self-reported symptoms. The changes were consistent in the within-group and between-group analyses. Our findings support the feasibility of remote and decentralized clinical studies of malodor conditions. Supplementary sample collection procedures may help to meet established research quality standards. Trial Registration: ClinicalTrials.gov NCT03582826; http://clinicaltrials.gov/ct2/show/NCT03582826

Background: Although nutrition interventions are a widely accepted resource for the prevention of long-term health conditions, current approaches have not adequately reduced chronic disease morbidity. Nutrigenomics has great potential; however, it is complicated to implement. There is a need for products based on nutrition-related gene test results that are easily understood, accessible, and used. Objective: The primary objective of this study was to compare a nonpractitioner-assisted direct-to-consumer self-driven approach to nutrigenomics versus an integrated and personalized practitioner-led method. Methods: This 4-month study used a mixed-methods design that included (1) a phase 1 randomized controlled trial that examined the effectiveness of a multifaceted, nutrition-based gene test (components assessed included major nutrients, food tolerances, food taste and preferences, and micronutrients) in changing health behaviors, followed by (2) a qualitative investigation that explored participants’ experiences. The study recruited 55 healthy males and females (aged 35-55 years) randomized as a 2:1 ratio where 36 received the intervention (gene test results plus integrated and personalized nutrition report) and 19 were assigned to the control group (gene test results report emailed). The primary outcomes of interest measures included changes in diet (nutrients, healthy eating index), changes in measures on General Self-efficacy and Health-Related Quality of Life scales, and anthropometrics (body mass index, waist-to-hip ratio) measured at baseline, post intervention (3 and 6 weeks), and the final visit (week 9 post intervention). Results: Of the 478 individuals who expressed interest, 180 were invited (37.7%, 180/478) and completed the eligibility screening questionnaire; 73 of the 180 invited individuals (40.5%) were deemed eligible. Of the 73 individuals who were deemed to be eligible, 58 completed the baseline health questionnaire and food records (79%). Of these 58 individuals, 3 were excluded either because they did not complete all required data collection forms or were later found to be ineligible. The final sample (n=55) was mostly female (75%), married (85%), and those who had completed postsecondary education (62%). Conclusions: This study will leverage quantitative and qualitative findings, which will guide the development of nutrigenomics-based products in electronic formats that are user-friendly for consumers and health professionals. Although the

Background: Outside health care, content tailoring is driven algorithmically using machine learning compared to the rule-based approach used in current implementations of computer-tailored health communication (CTHC) systems. A special class of machine learning systems (“recommender systems”) are used to select messages by combining the collective intelligence of their users (ie, the observed and inferred preferences of users as they interact with the system) and their user profiles. However, this approach has not been adequately tested for CTHC. Objective: Our aim was to compare, in a randomized experiment, a standard, evidence-based, rule-based CTHC (standard CTHC) to a novel machine learning CTHC: Patient Experience Recommender System for Persuasive Communication Tailoring (PERSPeCT). We hypothesized that PERSPeCT will select messages of higher influence than our standard CTHC system. This standard CTHC was proven effective in motivating smoking cessation in a prior randomized trial of 900 smokers (OR 1.70, 95% CI 1.03-2.81). Methods: PERSPeCT is an innovative hybrid machine learning recommender system that selects and sends motivational messages using algorithms that learn from message ratings from 846 previous participants (explicit feedback), and the prior explicit ratings of each individual participant. Current smokers (N=120) aged 18 years or older, English speaking, with Internet access were eligible to participate. These smokers were randomized to receive either PERSPeCT (intervention, n=74) or standard CTHC tailored messages (n=46). The study was conducted between October 2014 and January 2015. By randomization, we compared daily message ratings (mean of smoker ratings each day). At 30 days, we assessed the intervention’s perceived influence, 30-day cessation, and changes in readiness to quit from baseline. Results: The proportion of days when smokers agreed/strongly agreed (daily rating ≥4) that the messages influenced them to quit was significantly higher for PERSPeCT (73%, 23/30) than standard CTHC (44%, 14/30, P=.02). Among less educated smokers (n=49), this difference was even more pronounced for days strongly agree (intervention: 77%, 23/30; comparison: 23%, 7/30, P<.001). There was no significant difference in the frequency which PERSPeCT randomized smokers agreed or strongly agreed that the intervention influenced them to quit smoking (P=.07) and use nicotine replacement therapy (P=.09). Among those who completed follow-up, 36% (20/55) of PERSPeCT smokers and 32% (11/34) of the standard CTHC group stopped smoking for one day or longer (P=.70). Conclusions: Compared to standard CTHC with proven effectiveness, PERSPeCT outperformed in terms of influence ratings and resulted in similar cessation rates. ClinicalTrial: Clinicaltrials.gov NCT02200432; https://clinicaltrials.gov/ct2/show/NCT02200432 (Archived by WebCite at http://www.webcitation.org/6lEJY1KEd)

Background: Data collected by health care organizations consist of medical information and documentation of interactions with patients through different communication channels. This enables the health care organization to measure various features of its performance such as activity, efficiency, adherence to a treatment, and different quality indicators. This information can be linked to sociodemographic, clinical, and communication data with the health care providers and administrative teams. Analyzing all these measurements together may provide insights into the different types of patient behaviors or more accurately to the different types of interactions patients have with the health care organizations.

Background: Uncertainty is integral to evidence-informed decision making and is of particular importance for preference-sensitive decisions. Communicating uncertainty to patients and the public has long been identified as a goal in the informed and shared decision-making movement. Despite this, there is little quantitative research on how uncertainty in health information is perceived by readers. Objective: The objective of this study is to design an experiment to examine how different degrees of uncertainty (Q1) and different types of uncertainty (Q2) impact patients’ perception of treatment effectiveness, the body of evidence, text quality, and hypothetical treatment intention. The experiment also examines whether there is an additive effect when multiple sources of uncertainty are communicated (Q3). Methods: We developed 8 variations of a research summary set in a hypothetical scenario for a treatment decision in the context of tinnitus. These were modified only in the degree of uncertainty relating to the evidence of the presented treatment. We recruited members of the German public from a Web-based research panel and randomized them to one of 8 variations of the research summary to examine the 3 research questions. The trial was only open to the members of the research panel. The outcomes are perception of the effectiveness of the treatment (primary), certainty in the judgement of treatment effectiveness, perception of the body of evidence relating to the treatment, text quality, and decisional intention (secondary). Outcomes were self-assessed. We aimed to recruit 1500 participants to the trial. The recruitment and data collection was fully automated. Ethical approval was waivered by an ethics committee because of the negligible risk to participants. Results: This protocol is retrospectively published in its original format. In the meantime, the trial was set up and the data collection was completed. Data collection was conducted in May 2018. A total of 1727 eligible panel members were enrolled. Conclusions: We aim to publish the results in a peer-reviewed journal by the end of 2019. In addition, results will be presented at conferences and disseminated among developers of guidance for the development of evidence-based health information and decision aids.

Background: Hypertension remains one of the foremost noncommunicable diseases that most often lead to cardiovascular diseases and its different complications. The prevalence of hypertension in Bangladesh has been increasing. However, there are very limited studies that have evaluated the impact of health education and awareness development in mitigating the burden of hypertension and its complications in Bangladesh. Objective: This study aims to increase awareness, enhance knowledge, and change lifestyle behaviors through health education and the use of mobile health (mHealth) technology among individuals with hypertension living in a rural community of Bangladesh. Methods: A randomized controlled trial is underway in a Mirzapur subdistrict of Bangladesh. This trial compares two groups of individuals with hypertension: The comparison arm receives health education and the intervention arm receives health education and a periodic mobile phone–based text message intervention. The trial duration is 5 months. The primary end point is participants’ actual behavior changes brought about by increased awareness and knowledge. Results: Enrollment of participants started in August 2018, and collection of follow-up data was completed at the end of July 2019. A total of 420 participants volunteered to participate, and among them, 209 and 211 were randomly allocated to the intervention group and the control group, respectively. Among them, the ratio of males/females was 12.0/88.0 in the intervention group and 16.1/83.9 in the control group. Data cleaning and analyses have been completed and the results have been submitted for publication. Conclusions: Periodic short education using mHealth technology in addition to face-to-face health education may be an effective method for increasing awareness and knowledge about behavioral changes and maintaining healthy lifestyle behaviors. Trial Registration: Bangladesh Medical Research Council (BMRC) 06025072017; ClinicalTrials.gov NCT03614104, https://clinicaltrials.gov/ct2/show/NCT03614104; University hospital Medical Information Network (UMIN) R000033736, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_his_list.cgi?recptno=R000033736 International Registered Report Identifier (IRRID): DERR1-10.2196/15523

Background: College students are at elevated risk for developing mental health problems and face specific barriers around accessing evidence-based treatment. Web-based interventions that focus on mental health promotion and strengthening resilience represent one possible solution. Providing support to users has shown to reduce dropout in these interventions. Further research is needed to assess the efficacy and acceptability of these interventions and explore the viability of automating support. Objective: This study investigated the feasibility of a new web-based resilience program based on positive psychology, provided with human or automated support, in a sample of college students. Methods: A 3-armed closed pilot randomized controlled trial design was used. Participants were randomized to the intervention with human support (n=29), intervention with automated support (n=26), or waiting list (n=28) group. Primary outcomes were resilience and well-being, respectively measured by the Connor–Davidson Resilience Scale and Pemberton Happiness Index. Secondary outcomes included measures of depression and anxiety, self-esteem, and stress. Outcomes were self-assessed through online questionnaires. Intention-to-treat and per-protocol analyses were conducted. Results: All participants demonstrated significant improvements in resilience and related outcomes, including an unexpected improvement in the waiting list group. Within- and between-group effect sizes ranged from small to moderate and within-group effects were typically larger for the human than automated support group. A total of 36 participants began the program and completed 46.46% of it on average. Participants were generally satisfied with the program and found it easy to use. Conclusions: Findings support the feasibility of the intervention. Preliminary evidence for the equal benefit of human and automated support needs to be supported by further research with a larger sample. Results of this study will inform the development of a full-scale trial, from which stronger conclusions may be drawn. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 11866034; http://www.isrctn.com/ISRCTN11866034

Major postoperative morbidity and mortality remain common despite efforts to improve patient outcomes. Health information technologies have the potential to actualize advances in perioperative patient care, but failure to evaluate the usability of these technologies may hinder their implementation and acceptance. This protocol describes the usability testing of an innovative telemedicine-based intra-operative clinical support system, the Anesthesiology Control Tower, in which a team led by an attending anesthesiologist will use a combination of established and novel information technologies to provide evidence-based support to their colleagues in the operating room.

Background: The association between behavioral difficulties and academic attainment is well established. Recent policy advising schools on managing behavior has promoted the early identification of behavioral difficulties. There is also increasing research into mHealth interventions to provide support for emotional and behavioral difficulties for young people. Objective: The primary aim of the proposed research is to examine the effectiveness of an mHealth intervention, ReZone, in reducing emotional and behavioral difficulties in young people. Methods: The protocol is a cluster trial of 12 classes with N=120 students with classes randomized to ReZone or management as usual. Multilevel modeling will be used to compare ReZone versus management as usual accounting for classroom-level variation. Results: Baseline data collection started in February 2017 and ended in April 2017. Follow-up data collection started in April 2017 and ended in June 2017. Conclusions: The proposed research will provide evidence as to whether ReZone is effective at helping young people to self-manage when feeling overwhelmed. Trial Registration: ISRCTN 13425994; http://www.isrctn.com/ISRCTN13425994 (Archived by WebCite at http://www.webcitation.org/6tePwwiHk)

Background: Physiotherapy is essential for the successful rehabilitation of common shoulder injuries and following shoulder surgery. Patients may receive some training and supervision for shoulder physiotherapy through private pay or private insurance, but they are typically responsible for performing most of their physiotherapy independently at home. It is unknown how often patients perform their home exercises and if these exercises are performed correctly without supervision. There are no established tools for measuring this. It is, therefore, unclear if the full benefit of shoulder physiotherapy treatments is being realized. Objective: The proposed research will (1) validate a smartwatch and machine learning (ML) approach for evaluating adherence to shoulder exercise participation and technique in a clinical patient population with rotator cuff pathology; (2) quantify the rate of home physiotherapy adherence, determine the effects of adherence on recovery, and identify barriers to successful adherence; and (3) develop and pilot test an ethically conscious adherence-driven rehabilitation program that individualizes patient care based on their capacity to effectively participate in their home physiotherapy. Methods: This research will be conducted in 2 phases. The first phase is a prospective longitudinal cohort study, involving 120 patients undergoing physiotherapy for rotator cuff pathology. Patients will be issued a smartwatch that will record 9-axis inertial sensor data while they perform physiotherapy exercises both in the clinic and in the home setting. The data collected in the clinic under supervision will be used to train and validate our ML algorithms that classify shoulder physiotherapy exercise. The validated algorithms will then be used to assess home physiotherapy adherence from the inertial data collected at home. Validated outcome measures, including the Disabilities of the Arm, Shoulder, and Hand questionnaire; Numeric Pain Rating Scale; range of motion; shoulder strength; and work status, will be collected pretreatment, monthly through treatment, and at a final follow-up of 12 months. We will then relate improvement in patient outcomes to measured physiotherapy adherence and patient baseline variables in univariate and multivariate analyses. The second phase of this research will involve the evaluation of a novel rehabilitation program in a cohort of 20 patients. The program will promote patient physiotherapy engagement via the developed technology and support adherence-driven care decisions. Results: As of December 2019, 71 patients were screened for enrollment in the noninterventional validation phase of this study; 65 patients met the inclusion and exclusion criteria. Of these, 46 patients consented and 19 declined to participate in the study. Only 2 patients de-enrolled from the study and data collection is ongoing for the remaining 44. Conclusions: This study will provide new and important insights into shoulder physiotherapy adherence, the relationship between adherence and recovery, barriers to better adherence, and methods for addressing them.

Background: In the last decade, electronic health (eHealth) literacy has attracted the attention of the scientific community, as it is associated with the self-management of patients with chronic diseases and the quality and cost of care. It is estimated that 80% of people with chronic diseases are cared for at home by a family member, friend, or relative. Informal carers are susceptible to physical and mental health problems, as well as social and financial hardships. Nevertheless, there seems to be a research gap in terms of carers’ needs, skills, and available resources in the age of new technologies, with the vital role of eHealth literacy of the carers remaining unexplored. Objective: The aim of this study was to investigate the level of eHealth literacy and health literacy of primary and secondary carers of people with dementia, to explore the association between health and eHealth literacy, as well as their association with the caregiving variables: self-efficacy, coping, and caring perceptions. Methods: A sample of 200 primary carers (the carer who supports the people with dementia in everyday living) and 200 secondary carers (family member, friend, or other person in the social network assisting the primary carer in their role) will be recruited from dementia day care centers and Alzheimer’s associations in Greece and Cyprus. The study will be a cross-sectional correlational descriptive study. Tools to be used include the eHealth Literacy Scale adapted for carers to measure eHealth literacy, European Health Literacy Survey Questionnaire 16 (HLS-EU-Q16), Single Item Literacy Screener, Revised Scale for Caregiving Self-Efficacy, Carers of Older People in Europe (COPE) index for caregiving perceptions, and COPE brief to measure selected coping strategies. Descriptive statistics will be reported, and correlations between different variables will be explored with parametric and nonparametric measures. Results: As a preliminary study, the HLS-EU-Q16 has been validated in 107 older people. The internal consistency of the scale as estimated using Cronbach alpha coefficient was .77, somewhat lower than other validation studies. Recruitment of pilot study participants started in May 2017. Conclusions: Carers’ eHealth literacy is a new field. Whereas previous studies have focused on the role and impact of low eHealth literacy and health literacy among older adults, the eHealth literacy of carers, and in fact carers of people with dementia, has not been explored. We hypothesize an association between eHealth literacy and health literacy level with carers’ perceptions about caregiving role, self-efficacy, and coping strategies. A possible moderator in these associations is the secondary carers’

Background: Cancer survivorship in Ireland is increasing in both frequency and longevity. However, a significant proportion of cancer survivors are overweight. This has negative implications for long-term health outcomes, including increased risk of subsequent and secondary cancers. There is a need to identify interventions, which can improve physical and psychological outcomes that are practical in modern oncology care. Mobile health (mHealth) interventions demonstrate potential for positive health behavior change, but there is little evidence for the efficacy of mobile technology to improve health outcomes in cancer survivors. Objective: This study aims to investigate whether a personalized mHealth self-management lifestyle program is acceptable to participants and can improve physical and psychological outcomes of a subgroup of cancer survivors with increased health risks related to lifestyle behaviors. Methods: A sample of 123 cancer survivors (body mass index >25 kg/m2) was randomly assigned to the control (n=61) or intervention (n=62) group. The intervention group attended a 4-hour tailored lifestyle information session with a physiotherapist, dietician, and clinical psychologist to support self-management of health behavior. Over the following 12 weeks, participants engaged in personalized goal setting to incrementally increase physical activity (with feedback and review of goals through short message service text messaging contact). Objective measures of health behavior (ie, physical activity) were collected using Fitbit (Fitbit, Inc). Data on anthropometric, physiological, dietary behavior, and psychological measures were collected at baseline (T0), 12 weeks (T1; intervention end), and 24 weeks (T2; follow-up). Semistructured interviews were conducted to explore the retrospective acceptability of the Moving On program from the perspective of the recipients. Results: This paper details the protocol for the Moving On study. The project was funded in August 2017. Enrolment started in December 2017. Data collection completed in September 2018. Data analysis is underway, and results are expected in winter 2019. Conclusions: The results of this study will determine the efficacy and acceptability of an mHealth intervention using behavior change techniques to promote health behaviors that support physical health and well-being in cancer survivors and will therefore have implications for health care providers, patients, health psychologists, and technologists. International Registered Report Identifier (IRRID): DERR1-10.2196/13214

Background: Especially for single older adults with chronic diseases, physical inactivity and a poor social network are regarded as serious threats to their health and independence. The Active Plus intervention is an automated computer-tailored eHealth intervention that has been proven effective to promote physical activity (PA) in the general population of adults older than 50 years. Objective: The aim of this study was to report on the methods and results of the systematic adaptation of Active Plus to the wishes and needs of the subgroup of single people older than 65 years who have one or more chronic diseases, as this specific target population may encounter specific challenges regarding PA and social network. Methods: The Intervention Mapping (IM) protocol was used to systematically adapt the existing intervention to optimally suit this specific target population. A literature study was performed, and quantitative as well as qualitative data were derived from health care professionals (by questionnaires, n=10) and the target population (by focus group interviews, n=14), which were then systematically integrated into the adapted intervention. Results: As the health problems and the targeted behavior are largely the same in the original and adapted intervention, the outcome of the needs assessment was that the performance objectives remained the same. As found in the literature study and in data derived from health professionals and focus groups, the relative importance and operationalization of the relevant psychosocial determinants related to these objectives are different from the original intervention, resulting in a refinement of the change objectives to optimally fit the specific target population. This refinement also resulted in changes in the practical applications, program components, intervention materials, and the evaluation and implementation strategy for the subgroup of single, chronically impaired older adults. Conclusions: This study demonstrates that the adaptation of an existing intervention is an intensive process in which adopting the IM protocol is an invaluable tool. The study provides a broad insight in adapting interventions aimed at single older adults with a chronic disease. It is concluded that even when the new target population is a sizable segment of the original target population, the adapted intervention still needs considerable changes to optimally fit the needs and situational differences of the narrower target population.

Background: Smoking is the largest preventable cause of morbidity and mortality in Brazil. Education Against Tobacco (EAT) is a large network of medical students in 13 countries who volunteer for school-based prevention in the classroom setting. A recent quasi-experimental EAT study conducted in Germany showed significant short-term smoking cessation effects on 11- to 15-year-old adolescents.

Background: Dementia disease is a chronic condition that leads a person with dementia (PwD) into a state of progressive deterioration and a greater dependence in performing their activities of daily living (ADL). It is believed nowadays that PwDs and their informal caregivers can have a better life when provided with the appropriate services and support. Connected Health (CH) is a new technology-enabled model of chronic care delivery where the stakeholders are connected through a health portal, ensuring continuity and efficient flow of information. CH has demonstrated promising results regarding supporting informal home care and Aging in Place, and it has been increasingly considered by researchers and health care providers as a method for dementia home care management. Objective: This study aims to describe the development and implementation protocol of a CH platform system to support informal caregivers of PwDs at home. Methods: This is a longitudinal observational mixed methods study where quantitative and qualitative data will be combined for determining the utility of the CH platform for dementia home care. Dyads, consisting of a PwD and their informal caregiver living in the community, will be divided into 2 groups: the intervention group, which will receive the CH technology package at home, and the usual care group, which will not have any CH technology at all. Dyads will be followed up for 12 months during which they will continue with their traditional care plan, but in addition, the intervention group will receive the CH package for their use at home during 6 months (months 3 to 9 of the yearly follow-up). Further comprehensive assessments related to the caregiver’s and PwD’s emotional and physical well-being will be performed at the initial assessment and at 3, 6, 9, and 12 months using international and standardized validated questionnaires and semistructured individual interviews. Results: This 3-year funded study (2016-2019) is currently in its implementation phase and is expected to finish by December 2019. We believe that CH can potentially change the PwD current care model, facilitating a proactive and preventive model, utilizing self-management–based strategies, and enhancing caregivers’ involvement in the management of health care at home for PwDs. Conclusions: We foresee that our CH platform will provide knowledge and promote autonomy for the caregivers, which may empower them into greater control of the care for PwDs, and with it, improve the quality of life and well-being for the person they are caring for and for themselves through a physical and cognitive decline predictive model. We also believe that facilitating information sharing between all the PwDs’ care stakeholders may enable a stronger relationship between them, facilitate a more coordinated care plan, and increase the feelings of empowerment in the informal caregivers. International Registered Report Identifier (IRRID): DERR1-10.2196/13280

Background: The Great COVID-19 Shutdown aimed to eliminate or slow the spread of SARS-CoV-2, the virus that causes COVID-19. The United States has no national policy, leaving states to independently implement public health guidelines that are predicated on a sustained decline in COVID-19 cases. Operationalization of “sustained decline” varies by state and county. Existing models of COVID-19 transmission rely on parameters such as case estimates or R0 and are dependent on intensive data collection efforts. Static statistical models do not capture all of the relevant dynamics required to measure sustained declines. Moreover, existing COVID-19 models use data that are subject to significant measurement error and contamination. Objective: This study will generate novel metrics of speed, acceleration, jerk, and 7-day lag in the speed of COVID-19 transmission using state government tallies of SARS-CoV-2 infections, including state-level dynamics of SARS-CoV-2 infections. This study provides the prototype for a global surveillance system to inform public health practice, including novel standardized metrics of COVID-19 transmission, for use in combination with traditional surveillance tools. Methods: Dynamic panel data models were estimated with the Arellano-Bond estimator using the generalized method of moments. This statistical technique allows for the control of a variety of deficiencies in the existing data. Tests of the validity of the model and statistical techniques were applied. Results: The statistical approach was validated based on the regression results, which determined recent changes in the pattern of infection. During the weeks of August 17-23 and August 24-30, 2020, there were substantial regional differences in the evolution of the US pandemic. Census regions 1 and 2 were relatively quiet with a small but significant persistence effect that remained relatively unchanged from the prior 2 weeks. Census region 3 was sensitive to the number of tests administered, with a high constant rate of cases. A weekly special analysis showed that these results were driven by states with a high number of positive test reports from universities. Census region 4 had a high constant number of cases and a significantly increased persistence effect during the week of August 24-30. This change represents an increase in the transmission model R value for that week and is consistent with a re-emergence of the pandemic. Conclusions: Reopening the United States comes with three certainties: (1) the “social” end of the pandemic and reopening are going to occur before the “medical” end even while the pandemic is growing. We need improved standardized surveillance techniques to inform leaders when it is safe to open sections of the country; (2) varying public health policies and guidelines unnecessarily result in varying degrees of transmission and outbreaks; and (3) even those states most successful in containing the pandemic continue to see a small but constant stream of new cases daily.

Traffic light labelling of foods—a system that incorporates a colour-coded assessment of the level of total fat, saturated fat, sugar and salt on the front of packaged foods—has been recommended by the UK Government and is currently in use or being phased in by many UK manufacturers and retailers. This paper describes a protocol for a pilot randomised controlled trial of an intervention designed to increase the use of traffic light labelling during real-life food purchase decisions.

Background: The unprecedented coverage of mobile technology across the globe has led to an increase in the use of mobile health apps and related strategies to make health information available at the point of care. These strategies have the potential to improve birth outcomes, but are limited by the availability of Internet services, especially in resource-limited settings such as Nigeria. Objective: Our primary objective is to determine the feasibility of developing an integrated mobile health platform that is able to collect data from community-based programs, embed collected data into a smart card, and read the smart card using a mobile phone-based app without the need for Internet access. Our secondary objectives are to determine (1) the acceptability of the smart card among pregnant women and (2) the usability of the smart card by pregnant women and health facilities in rural Nigeria. Methods: We will leverage existing technology to develop a platform that integrates a database, smart card technology, and a mobile phone-based app to read the smart cards. We will recruit 300 pregnant women with one of the three conditions—HIV, hepatitis B virus infection, and sickle cell trait or disease—and four health facilities in their community. We will use Glasgow’s Reach, Effectiveness, Adoption, Implementation, and Maintenance framework as a guide to assess the implementation, acceptability, and usability of the mHealth platform. Results: We have recruited four health facilities and 300 pregnant women with at least one of the eligible conditions. Over the course of 3 months, we will complete the development of the mobile health platform and each participant will be offered a smart card; staff in each health facility will receive training on the use of the mobile health platform. Conclusions: Findings from this study could offer a new approach to making health data from pregnant women available at the point of delivery without the need for an Internet connection. This would allow clinicians to implement evidence-based interventions in real time to improve health outcomes. Trial Registration: ClinicalTrials.gov NCT03027258; https://clinicaltrials.gov/ct2/show/NCT03027258 (Archived by WebCite at http://www.webcitation.org/6owR2D0kE)

Background: Despite growing evidence of deleterious health outcomes associated with sedentary behavior, prolonged static sitting in classrooms remains ubiquitous in primary schools. Sedentary behavior is associated with the development of cardio-metabolic conditions and poor back health. Preventative strategies to reduce sedentary behavior and its negative health effects may be required in a resource-constrained environment such as South Africa. Objective: The primary objective of this study is to assess the feasibility of conducting a full trial to evaluate the effects of a multifaceted intervention comprising novel multifunctional classroom furniture and a video-based curriculum versus usual care on sedentary behavior among students aged 10-11 years in primary schools. The secondary objective is to assess the preliminary effects of the intervention on sedentary behavior and postural dynamism. Methods: Eighty grade 5 or 6 students, aged 10 and 11 years, in mixed-gender schools within the Western Cape metropolitan urban area in Cape Town, South Africa are eligible to participate in this pilot cluster stepped-wedge trial design with classroom as the unit of randomization. Data will be collected at the schools. The intervention will comprise multifunctional classroom furniture that allows for sitting and standing as well as a video-based curriculum on sedentary behavior. Usual practice is the absence of the intervention. The primary outcomes assessed will be (1) adherence to the intervention and (2) project pragmatics. The secondary outcomes will be (1) sedentariness measured using activPAL3 microsensors and (2) postural dynamism measured using Noraxon Myomotion inertial measurement units. We randomized the school to the first or second start of the intervention. This is an open-label trial and therefore blinding will not be possible for any group. Descriptive analysis of the feasibility and physiological outcomes will be presented. We will report the preliminary estimates of the effects of the intervention on sedentariness and postural dynamism using the mean difference and 95% CI. Results: At the time of submission, two classrooms have been recruited into the study. Baseline physical activity and postural dynamism data have been collected from 10 participants from each class. Conclusions: The results of this feasibility stepped-wedge cluster randomized controlled trial will be useful in informing the design of the main trial to assess whether this multifaceted intervention of multifunctional classroom furniture that allows for sitting and standing as well as a video-based curriculum versus usual care has any effect on sedentary behavior in low-resource-setting primary schools. Trial Registration: Pan African Trials Registry PACTR201811799476016; https://tinyurl.com/y4upoys8

Background: Although youth with disabilities have much to gain from employment readiness programs, they are often excluded from or have limited access to vocational programs. One encouraging approach to address gaps in vocational programming is through peer electronic mentoring (e-mentoring), which may facilitate a smoother transition to adulthood by offering support to enhance coping skills. Despite the increase in online communities, little is known about their impact on vocational mentoring for youth with physical disabilities and their parents. Objective: The aim of this paper is to develop, implement, and assess the feasibility of an online peer mentor employment readiness intervention for youth with physical disabilities and their parents to improve their self-determination, career maturity, and social support compared to controls. Methods: A mixed-methods feasibility randomized controlled trial (RCT) design will be conducted to develop and assess the feasibility, acceptability, and initial efficacy of the “Empowering Youth Towards Employment” intervention. Youth (aged 15 to 25) with physical disabilities and their parents will be randomly assigned to a control or experimental group (4-week, interactive intervention, moderated by peer mentors). Results: Data collection is in progress. Planned analyses include pre-post measures to determine the impact of the intervention on self-determination, career maturity, and social support. A qualitative thematic analysis of the discussion forums will complement the surveys to better understand why certain outcomes may have occurred. Conclusions: Our intervention includes evidence-informed content and was co-created by a multi-disciplinary group of researchers and knowledge users. It has the potential for widespread implications as a cost-effective resource to supplement educational and vocational programming for youth with disabilities. Trial Registration: Clinicaltrials.gov NCT02522507; https://clinicaltrials.gov/ct2/show/NCT02522507 (Archived by WebCite at http://www.webcitation.org/6uD58Pvjc)

Background: Awareness of lung cancer screening remains low in the screening-eligible population, and when patients visit their clinician never having heard of lung cancer screening, engaging in shared decision making to arrive at an informed decision can be a challenge. Therefore, methods to effectively support both patients and clinicians to engage in these important discussions are essential. To facilitate shared decision making about lung cancer screening, effective methods to prepare patients to have these important discussions with their clinician are needed. Objective: Our objective is to develop a computer-tailored decision support tool that meets the certification criteria of the International Patient Decision Aid Standards instrument version 4.0 that will support shared decision making in lung cancer screening decisions. Methods: Using a 3-phase process, we will develop and test a prototype of a computer-tailored decision support tool in a sample of lung cancer screening-eligible individuals. In phase I, we assembled a community advisory board comprising 10 screening-eligible individuals to develop the prototype. In phase II, we recruited a sample of 13 screening-eligible individuals to test the prototype for usability, acceptability, and satisfaction. In phase III, we are conducting a pilot randomized controlled trial (RCT) with 60 screening-eligible participants who have never been screened for lung cancer. Outcomes tested include lung cancer and screening knowledge, lung cancer screening health beliefs (perceived risk, perceived benefits, perceived barriers, and self-efficacy), perception of being prepared to engage in a patient-clinician discussion about lung cancer screening, occurrence of a patient-clinician discussion about lung cancer screening, and stage of adoption for lung cancer screening. Results: Phases I and II are complete. Phase III is underway. As of July 15, 2017, 60 participants have been enrolled into the study, and have completed the baseline survey, intervention, and first follow-up survey. We expect to have results by December 31, 2017 and to have data analysis completed by March 1, 2018. Conclusions: Results from usability testing indicate that the computer-tailored decision support tool is easy to use, is helpful, and provides a satisfactory experience for the user. At the conclusion of phase III (pilot RCT), we will have preliminary effect sizes to inform a future fully powered RCT on changes in (1) knowledge about lung cancer and screening, (2) perceived risk of lung cancer, (3) perceived benefits of lung cancer screening, (4) perceived barriers to lung cancer screening, (5) self-efficacy for

In recent years, businesses worldwide have shown a growing interest in adopting corporate social responsibility (CSR) practices. The driver of corporate CSR engagement has attracted widespread attention. This study seeks to examine how firms react to the CSR practices of their peers in China. The ordinary least square would be used to validate our hypothesis and the instrumental variable approach would be utilized to alleviate endogeneity threats. In addition, we propose two channels, named as market competition hypothesis and institutional pressure hypothesis to account for this peer effect. We plan to provide some empirical evidence to support both channels.

Background: Atrial fibrillation (AF) is an increasingly common chronic health condition for which integrated care that is multidisciplinary and patient-centric is recommended yet challenging to implement. Objective: The aim of Coordinating Health Care With Artificial Intelligence–Supported Technology in AF is to evaluate the feasibility and potential efficacy of a digital intervention (AF-Support) comprising preprogrammed automated telephone calls (artificial intelligence conversational technology), SMS text messages, and emails, as well as an educational website, to support patients with AF in self-managing their condition and coordinate primary and secondary care follow-up. Methods: Coordinating Health Care With Artificial Intelligence–Supported Technology in AF is a 6-month randomized controlled trial of adult patients with AF (n=385), who will be allocated in a ratio of 4:1 to AF-Support or usual care, with postintervention semistructured interviews. The primary outcome is AF-related quality of life, and the secondary outcomes include cardiovascular risk factors, outcomes, and health care use. The 4:1 allocation design enables a detailed examination of the feasibility, uptake, and process of the implementation of AF-Support. Participants with new or ongoing AF will be recruited from hospitals and specialist-led clinics in Sydney, New South Wales, Australia. AF-Support has been co-designed with clinicians, researchers, information technologists, and patients. Automated telephone calls will occur 7 times, with the first call triggered to commence 24 to 48 hours after enrollment. Calls follow a standard flow but are customized to vary depending on patients’ responses. Calls assess AF symptoms, and participants’ responses will trigger different system responses based on prespecified protocols, including the identification of red flags requiring escalation. Randomization will be performed electronically, and allocation concealment will be ensured. Because of the nature of this trial, only outcome assessors and data analysts will be blinded. For the primary outcome, groups will be compared using an analysis of covariance adjusted for corresponding baseline values. Randomized trial data analysis will be performed according to the intention-to-treat principle, and qualitative data will be thematically analyzed. Results: Ethics approval was granted by the Western Sydney Local Health District Human Ethics Research Committee, and recruitment started in December 2020. As of December 2021, a total of 103 patients had been recruited. Conclusions: This study will address the gap in knowledge with respect to the role of postdischarge digital care models for supporting patients with AF. Clinical Trial: Australian New Zealand Clinical Trials Registry ACTRN12621000174886; https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12621000174886

Introduction Digital health measures promise to further improve the quality of cardiovascular care but have not yet been widely implemented in routine care. The research project Digital preventive measures for arterial hypertension (DiPaH) will systematically identify structural and individual factors in different stakeholders that influence the use of digital preventive measures in patients with arterial hypertension in Germany. Special focus is given to remote and sparsely populated areas, the age-specific impact, as well as influence of digital health literacy. Methods and analysis The DiPaH project is an exploratory cross-sectional study with a mixed-methods design, in which written surveys and interviews with patients and physicians will be conducted. In addition, secondary data from a health insurance company will be analyzed. In module 1, individuals from the database of the health insurance company with confirmed arterial hypertension will be interviewed (1,600 questionnaires, 30 interviews). Module 2 includes users of digital prevention offers and apps (400 questionnaires, 40 interviews) and in module 3, family physicians and cardiologists will be interviewed (400 questionnaires, 40 interviews). In a final module, the overall results will be analyzed and recommendations for interventions in clinical care will be derived. Discussion The DiPaH project will contribute to a patient-oriented and demand-based improvement of arterial hypertension prevention services in health care. Challenges and barriers will be analyzed and the respective target groups identified based on their prevention needs and social characteristics to enable a patient-centered implementation of digital prevention of arterial hypertension and cardiovascular services in general, and finally to improve cardiovascular outcomes. Clinical trial registration https://drks.de/search/de/trial/DRKS00029761 , identifier DRKS00029761.

Background: Health care providers resort to informal temporary practices known as workarounds for handling exceptions to normal workflow that are unintentionally imposed by electronic health record (EHR) systems. Although workarounds may seem favorable at first sight, they are generally suboptimal and may jeopardize patient safety, effectiveness, and efficiency of care. Identifying workarounds and understanding their motivations, scope, and impact is pivotal to support the design of user-friendly EHRs and achieve closer alignment between EHRs and work contexts. Objective: We propose a study protocol to identify EHR workarounds and subsequently determine their scope and impact on health care providers’ workflows, patient safety, effectiveness, and efficiency of care. First, knowing whether a workaround solely affects the health care provider who devised it, or whether its effects extends beyond the EHR user to the work context of other health care providers, is key to accurately assessing its degree of influence on the overall patient care workflow. Second, knowing whether the consequence of an EHR workaround is favorable or unfavorable provides insights into how to address EHR-related safety, effectiveness, and efficiency concerns. Knowledge of both perspectives can provide input on optimizing EHR designs. Methods: In the study, a combination of direct observations, semistructured interviews, and qualitative coding techniques will be used to identify, analyze, and classify EHR workarounds. The research project will be conducted within three distinct pediatric care processes and settings at a large university hospital. Results: Data was collected using the described approach from January 2016 to March 2017. Data analysis is underway and is expected to be completed in May 2017. We aim to report the results of this study in a follow-up publication. Conclusions: This study protocol provides a grounded framework to explore EHR workarounds from a holistic and integral perspective. Insights from this study can inform the design and redesign of EHRs to further align with work contexts of healthcare professionals, and subsequently lead to better organization and safer provision of care.

Background: Effective antiretroviral therapy has greatly reduced HIV-related morbidity and mortality, dramatically changing the demographics of the population of people living with HIV. The majority of people living with HIV in France are well cared for insofar as their HIV infection is concerned but remain at risk for age-associated comorbidities. Their long-term, potentially complex, and growing care needs make the routine, longitudinal assessment of health-related quality of life and other patient-reported outcomes of relevance in the current treatment era. Objective: We aim to describe the development of a Web-based electronic patient-reported outcomes system for people living with HIV linked to the ANRS CO3 Aquitaine cohort’s data capture and visualization system (ARPEGE) and designed to facilitate the electronic collection of patient-reported data and ultimately promote better patient-physician communication and quality of care (both patient satisfaction and health outcomes). Methods: Participants who meet the eligibility criteria will be invited to engage with the Web-based electronic patient-reported outcomes system and provided with the information necessary to create a personal patient account. They will then be able to access the electronic patient-reported outcomes system and complete a set of standardized validated questionnaires covering health-related quality of life (World Health Organization's Quality of Life Instrument in HIV infection, named WHOQOL-HIV BREF) and other patient-reported outcomes. The information provided via questionnaires will ultimately be presented in a summary format for clinicians, together with the patient’s HIV care history. Results: The prototype of the Web-based electronic patient-reported outcome system will be finalized and the first 2 formative research phases of the study (prototyping and usability testing) will be conducted from December 2017 to May 2018. We describe the sequential processes planned to ensure that the proposed electronic patient-reported outcome system is ready for formal pilot testing, referred to herein as phases 1a and 1b. We also describe the planned pilot-testing designed to evaluate the acceptability and use of the system from the patient’s perspective (phase 2). Conclusions: As the underlying information technology solution, ARPEGE, has being developed in-house, should the feasibility study presented here yield promising results, the panel of services provided via the proposed portal could ultimately be expanded and used to experiment with health-promoting interventions in aging people living with HIV in hospital-based care or adapted for use in other patient populations. Trial Registration: ClinicalTrials.gov NCT03296202; https://clinicaltrials.gov/ct2/show/NCT03296202 (Archived by WebCite at http://www.webcitation.org/6zgOBArps) Registered Report Identifier: RR1-10.2196/9439

Background: In the primary and secondary prevention of civilization diseases, regular physical activity is recommended in international guidelines to improve disease-related symptoms, delay the progression of the disease, or to enhance postoperative outcomes. In the preoperative context, there has been a paradigm shift in favor of using preconditioning concepts before surgery. Web-based interventions seem an innovative and effective tool for delivering general information, individualized exercise recommendations, and peer support.

Background: Visual analytics (VA) promotes the understanding of data using visual, interactive techniques and using analytic and visual engines. The analytic engine includes machine learning and other automated techniques, whereas common visual outputs include flow maps and spatiotemporal hotspots for studying service gaps and disease distribution. The principal objective of this scoping review is to examine the state of science on VA and the various tools, strategies, and frameworks used in population health and health services research (HSR).

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.