Testing the Effect of a Smartphone App on Hospital Admissions and Sedentary Behavior in Cardiac Rehabilitation Participants: ToDo-CR Randomized Controlled Trial.

BACKGROUND: People with coronary heart disease are at an increased risk of morbidity and mortality even if they attend cardiac rehabilitation. High sedentary behavior levels potentially contribute to this morbidity. Smartphone apps may be feasible to facilitate sedentary behavior reductions and lead to reduced health care use. OBJECTIVE: We aimed to test the effect of a sedentary behavior change smartphone app (Vire app and ToDo-CR program) as an adjunct to cardiac rehabilitation on hospital admissions and emergency department (ED) presentations over 12 months. METHODS: A multicenter, randomized controlled trial was conducted with 120 participants recruited from 3 cardiac rehabilitation programs. Participants were randomized 1:1 to cardiac rehabilitation plus the fully automated 6-month Vire app and ToDo-CR program (intervention) or usual care (control). The primary outcome was nonelective hospital admissions and ED presentations over 12 months. Secondary outcomes including accelerometer-measured sedentary behavior, BMI, waist circumference, and quality of life were recorded at baseline and 6 and 12 months. Logistic regression models were used to analyze the primary outcome, and linear mixed-effects models were used to analyze secondary outcomes. Data on intervention and hospital admission costs were collected, and the incremental cost-effectiveness ratios (ICERs) were calculated. RESULTS: Participants were, on average, aged 62 (SD 10) years, and the majority were male (93/120, 77.5%). The intervention group were more likely to experience all-cause (odds ratio [OR] 1.54, 95% CI 0.58-4.10; P=.39) and cardiac-related (OR 3.26, 95% CI 0.84-12.55; P=.09) hospital admissions and ED presentations (OR 2.07, 95% CI 0.89-4.77; P=.09) than the control group. Despite this, cardiac-related hospital admission costs were lower in the intervention group over 12 months (Aus $252.40 vs Aus $859.38; P=.24; a currency exchange rate of Aus $1=US $0.69 is applicable). There were no significant between-group differences in sedentary behavior minutes per day over 12 months, although the intervention group completed 22 minutes less than the control group (95% CI -22.80 to 66.69; P=.33; Cohen d=0.21). The intervention group had a lower BMI (ß=1.62; P=.05), waist circumference (ß=5.81; P=.01), waist-to-hip ratio (ß=.03, P=.03), and quality of life (ß=3.30; P=.05) than the control group. The intervention was more effective but more costly in reducing sedentary behavior (ICER Aus $351.77) and anxiety (ICER Aus $10,987.71) at 12 months. The intervention was also more effective yet costly in increasing quality of life (ICER Aus $93,395.50) at 12 months. CONCLUSIONS: The Vire app and ToDo-CR program was not an outcome-effective or cost-effective solution to reduce all-cause hospital admissions or ED presentations in cardiac rehabilitation compared with usual care. Smartphone apps that target sedentary behavior alone may not be an effective solution for cardiac rehabilitation participants to reduce hospital admissions and sedentary behavior. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001223123; https://australianclinicaltrials.gov.au/anzctr/trial/ACTRN12619001223123. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2020-040479.

A smartphone app for sedentary behaviour change in cardiac rehabilitation and the effect on hospital admissions: the ToDo-CR randomised controlled trial study protocol.

INTRODUCTION: Cardiac rehabilitation (CR) is recommended for secondary prevention of cardiovascular disease and reducing the risk of repeat cardiac events. Physical activity is a core component of CR; however, studies show that participants remain largely sedentary. Sedentary behaviour is an independent risk factor for all-cause mortality. Strategies to encourage sedentary behaviour change are needed. This study will explore the effectiveness and costs of a smartphone application (Vire) and an individualised online behaviour change program (ToDo-CR) in reducing sedentary behaviour, all-cause hospital admissions and emergency department visits over 12 months after commencing CR. METHODS AND ANALYSIS: A multicentre, assessor-blind parallel randomised controlled trial will be conducted with 144 participants (18+ years). Participants will be recruited from three phase-II CR centres. They will be assessed on admission to CR and randomly assigned (1:1) to one of two groups: CR plus the ToDo-CR 6-month programme or usual care CR. Both groups will be re-assessed at 6 months and 12 months for the primary outcome of all-cause hospital admissions and presentations to the emergency department. Accelerometer-measured changes in sedentary behaviour and physical activity will also be assessed. Logistic regression models will be used for the primary outcome of hospital admissions and emergency department visits. Methods for repeated measures analysis will be used for all other outcomes. A cost-effectiveness analysis will be conducted to evaluate the effects of the intervention on the rates of hospital admissions and emergency department visits within the 12 months post commencing CR. ETHICS AND DISSEMINATION: This study received ethical approval from the Australian Capital Territory Health (2019.ETH.00162), Calvary Public Hospital Bruce (20-2019) and the University of Canberra (HREC-2325) Human Research Ethics Committees (HREC). Results will be disseminated through peer-reviewed academic journals. Results will be made available to participants on request. TRIAL REGISTRATION NUMBER: ACTRN12619001223123.

A Behavioral Change Smartphone App and Program (ToDo-CR) to Decrease Sedentary Behavior in Cardiac Rehabilitation Participants: Prospective Feasibility Cohort Study.

BACKGROUND: Cardiac rehabilitation participants are encouraged to meet physical activity guidelines to reduce the risk of repeat cardiac events. However, previous studies have found that physical activity levels are low and sedentary behavior is high, both during and after cardiac rehabilitation. There is potential for smartphone apps to be effective in reducing sedentary behavior, although among the few studies that have investigated smartphone apps in cardiac rehabilitation, none targeted sedentary behavior. OBJECTIVE: This study aims to evaluate the feasibility of a behavioral smartphone app (Vire) and a web-based behavior change program (ToDo-CR) to decrease sedentary behavior in cardiac rehabilitation participants. METHODS: Using a single-center, pre-post design, participants were recruited by nursing staff on admission to cardiac rehabilitation. All eligible participants installed the Vire app, were given a Fitbit Flex, and received the 6-week ToDo-CR program while attending cardiac rehabilitation. The ToDo-CR program uses personalized analytics to interpret important behavioral aspects (physical activity, variety, and social opportunity) and real-time information for generating and suggesting context-specific actionable microbehavioral alternatives (Do's). Do's were delivered via the app, with participants receiving 14 to 19 Do's during the 6-week intervention period. Outcome measures were collected at 0, 6, and 16 weeks. The assessors were not blinded. Feasibility outcomes included recruitment and follow-up rates, resource requirements, app usability (Unified Theory of Acceptance and Use of Technology 2 [UTAUT2] questionnaire), and objectively measured daily minutes of sedentary behavior (ActiGraph) for sample size estimation. Secondary outcomes included functional aerobic capacity (6-min walk test), quality of life (MacNew Heart Disease Health-Related Quality of Life Questionnaire), anxiety and depression (Hospital Anxiety and Depression Scale questionnaire), BMI, waist circumference, waist-to-hip ratio, and blood pressure. RESULTS: Between January and May 2019, 20 participants were recruited consecutively. One-third of people who commenced cardiac rehabilitation were eligible to participate. Other than declining to take part in the study (15/40, 38%), not having a smartphone was a major reason for exclusion (11/40, 28%). Those excluded without a smartphone were significantly older than participants with a smartphone (mean difference 20 [SD 5] years; P<.001). Participants were, on average, aged 54 (SD 13) years, mostly male (17/20, 85%), and working (12/20, 67%). At 6 weeks, 95% (19/20) of participants were assessed, and 60% (12/20) of participants were assessed at 16 weeks. Participants were relatively satisfied with the usability of the app (UTAUT2 questionnaire). Overall, participants spent 11 to 12 hours per day sitting. There was a medium effect size (Cohen d=0.54) for the reduction in sedentary behavior (minutes per day) over 16 weeks. CONCLUSIONS: The use of a behavioral smartphone app to decrease sitting time appears to be feasible in cardiac rehabilitation. A larger randomized controlled trial is warranted to determine the effectiveness of the app.

Do CHANGE platform: A service-based architecture for secure aggregation and distribution of health and wellbeing data.

Over the last decade, the adoption of open API standards offers new services meaningful in the domain of health informatics and behavior change. We present our privacy-oriented solution to support personal data collection, distribution, and usage. Given the new General Data Protection Regulations in Europe, the proposed platform is designed with requirements in mind to position citizens as the controllers of their data. The proposed result uses NodeJS servers, OAuth protocol for Authentication and Authorization, a publish-subscribe semantic for real-time data notification and Cron for APIs without a notification strategy. It uses Distributed Data Protocol to control and securely provision data to distributed frameworks utilizing the data and those distributed applications are exemplified. The platform design is transparent and modularized for research projects and small businesses to set-up and manage, and to allow them to focus on the application layer utilizing personal information. This solution can easily be configured to support custom or new data sources with open API and can scale. In our use cases, maintaining the separate ecosystem services was trivial. The adopted distributed protocol was the most challenging to manage due to its high RAM usage. And implementing a fine-grained privacy control by end-users was challenging in an existing clinical enterprise system.