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

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 (β=1.62; P=.05), waist circumference (β=5.81; P=.01), waist-to-hip ratio (β=.03, P=.03), and quality of life (β=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. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001223123; https://australianclinicaltrials.gov.au/anzctr/trial/ACTRN12619001223123 INTERNATIONAL REGISTERED REPORT RR2-10.1136/bmjopen-2020-040479