Personalized eHealth Program for Lifestyle Change: Results from the "Do Cardiac Health Advanced New Generated Ecosystem (Do CHANGE 2)" Randomized Controlled Trial.

OBJECTIVE: Unhealthy lifestyle 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 CHANGE 2 intervention and evaluates effects on: 1) lifestyle, and 2) 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-behaviour assessment technologies for six months combined with a 3-month behavioural intervention program. Linear Mixed Models (LMM) analysis wERE used to evaluate the intervention effects and latent class analysis (LCA) was used for secondary subgroup analysis. RESULTS: LMM analysis showed significant intervention effects for lifestyle behaviour (Finteraction(2,138.5)=5.97, p =.003), with improvement of lifestyle behaviour 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) were found. Secondary LCA revealed different subgroups of patients per outcome measure. The intervention was experienced as useful and feasible. CONCLUSION: The personalized eHealth intervention resulted in significant improvements in lifestyle. Cardiac patients and health care providers were also willing to engage in this personalized digital behavioural intervention program. Incorporating eHealth lifestyle 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.