Abstract
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 smartphone technology in patients with high cardiovascular risk. Methods and Results: This prospective, randomised and single-centre clinical investigation enrolled 242 and 241 patients to the intervention plus usual care and usual care arms, respectively. After a follow-up of 1-year, 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 end points. 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. Conclusion: The lifestyle intervention using smartphone technology compared to usual care alone in patients with high cardiovascular risk reduced the ASCVD score at 1-year follow-up. Clinical Trial Registration: The trial was registered at www.clinicaltrials.gov (NCT03397849). Funding Statement: TThis work was supported by Turk Telekomunikasyon A.S. The study was performed at Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Turkey. Declaration of Interests: None declared. Ethics Approval Statement: The study protocol complies with the Declaration of Helsinki and it was approved by the local ethics committee of the Haydarpasa Numune Training and Research Hospital, Istanbul, Turkey (approval no. 2017/78). All the participants provided written informed consent.
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