Management of cardiovascular disease using an mHealth tool: a randomized clinical trial.

Atherosclerotic cardiovascular disease (ASCVD) is a leading cause of death and morbidity worldwide. This randomized controlled, single-center, open-label trial tested the impact of a mobile health (mHealth) service tool optimized for ASCVD patient care. Patients with clinical ASCVD were enrolled and randomly assigned to the intervention or control group. Participants in the intervention group were provided with a smartphone application named HEART4U, while a dedicated interface integrated into the electronic healthcare record system was provided to the treating physicians. A total of 666 patients with ASCVD were enrolled, with 333 patients in each group. The estimated baseline 10-year risk of cardiovascular disease was 9.5% and 10.8% in the intervention and control groups, respectively, as assessed by the pooled cohort risk equations. The primary study endpoint was the change in the estimated risk at six months. The estimated risk increased by 1.3% and 1.1%, respectively, which did not differ significantly (P = 0.821). None of the secondary study endpoints showed significant differences between the groups. A post-hoc subgroup analysis showed the benefit was greater if a participant in the intervention group accessed the application more frequently. The present study demonstrated no significant benefits associated with the use of the mHealth tool in terms of the predefined study endpoints in stable patients with ASCVD. However, it also suggested that motivating patients to use the mHealth tool more frequently may lead to greater clinical benefit. Better design with a positive user experience needs to be considered for developing future mHealth tools for ASCVD patient care.Trial Registration: ClinicalTrials.gov NCT03392259.