Lifestyle intervention using mobile technology and smart devices in patients with high cardiovascular risk: A pragmatic randomised clinical trial.

BACKGROUND AND AIMS: Mobile technology-based solutions present promising effects against cardiovascular diseases. Long-term follow-up in mobile phone-based interventions has not yet been elucidated as a primary prevention technique for cardiovascular diseases. The objective of the present trial is to evaluate the effectiveness of lifestyle intervention on the change in the atherosclerotic cardiovascular disease (ASCVD) risk score in a 1-year follow-up using smart phone technology in patients with high cardiovascular risk. METHODS: This prospective, randomised, single-centre clinical investigation enrolled 242 and 241 patients to the intervention plus usual care and usual care arms, respectively. The primary outcome of this study was the 1-year ASCVD risk score adjusted to baseline ASCVD risk score. ASCVD risk scores were calculated for every study participant at the randomisation and final stages. RESULTS: After a 1-year follow-up, the intervention plus usual care reduced the ASCVD score by 2.7% (adjusted treatment effect -2.7, 95% confidence interval (CI): -2.2,-3.3, p<0.0001). An improvement was observed in favour of the intervention plus usual care arm in the majority of the pre-specified secondary endpoints. The high sensitive troponin and high sensitive C-reactive protein levels at 1 year were similar between the two arms. The treatment effect was homogenous for diabetes mellitus, gender, systolic blood pressure, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides and body mass index; however, heterogeneity in the treatment effect was observed for age. CONCLUSIONS: The lifestyle intervention using smart phone technology compared to usual care alone in patients with high cardiovascular risk reduced the ASCVD score at 1-year follow-up.