Abstract
OBJECTIVE Unhealthy life-style factors have adverse outcomes in cardiac patients. However, only a minority of patients succeed to change unhealthy habits. Personalization of interventions may result in critical improvements. The current randomized controlled trial provides a proof of concept of the personalized Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) 2 intervention and evaluates effects on a) life-style and b) quality of life over time. METHODS Cardiac patients (n = 150; mean age = 61.97 ± 11.61 years; 28.7% women; heart failure, n = 33; coronary artery disease, n = 50; hypertension, n = 67) recruited from Spain and the Netherlands were randomized to either the "Do CHANGE 2" or "care as usual" group. The Do CHANGE 2 group received ambulatory health-behavior assessment technologies for 6 months combined with a 3-month behavioral intervention program. Linear mixed-model analysis was used to evaluate the intervention effects, and latent class analysis was used for secondary subgroup analysis. RESULTS Linear mixed-model analysis showed significant intervention effects for life-style behavior (Finteraction(2,138.5) = 5.97, p = .003), with improvement of life-style behavior in the intervention group. For quality of life, no significant main effect (F(1,138.18) = .58, p = .447) or interaction effect (F(2,133.1) = 0.41, p = .67) was found. Secondary latent class analysis revealed different subgroups of patients per outcome measure. The intervention was experienced as useful and feasible. CONCLUSIONS The personalized eHealth intervention resulted in significant improvements in life-style. Cardiac patients and health care providers were also willing to engage in this personalized digital behavioral intervention program. Incorporating eHealth life-style programs as part of secondary prevention would be particularly useful when taking into account which patients are most likely to benefit. TRIAL REGISTRATION https://clinicaltrials.gov/ct2/show/NCT03178305.
