Lasting Empowerment After Discontinuing a Heart Failure Telemonitoring Program: A Randomized Controlled Trial.

Abstract

This study evaluated the long-term effects of the ControlVit mobile application on clinical outcomes and patient empowerment in individuals with chronic heart failure (HF), 6 months after discontinuation of the app. In this open-label, randomized, controlled clinical trial, patients were assigned to either an intervention group receiving standard HF management plus the ControlVit app for 6 months or to a control group receiving standard care alone. After 6 months, app use was discontinued, and all participants were followed for an additional 6 months. The primary outcome was the composite of death or HF-related hospital readmission at 12 months, whereas secondary outcomes included changes in body weight, natriuretic peptide levels, New York Heart Association (NYHA) functional class, and patient empowerment, measured using the Empowerment Evaluation Scale (EES). A total of 140 patients were enrolled (28.6% women; mean age, 67 y). At 12 months, 8 patients (11.4%) in the intervention group and 3 patients (4.3%) in the control group experienced the primary outcome [relative risk (RR): 2.62; 95% CI: 0.73-9.52; P=.122). Empowerment levels were significantly higher among app users compared with controls (EES score: 4.68 ± 0.36 vs. 4.40 ± 1.91; P=.012). Use of SGLT2 inhibitors and ARNi increased significantly in both groups during follow-up (ControlVit: 60% to 85%, P<.001; Control: 51.4% to 75%, P<.001). Among outpatients with chronic HF participating in a structured HF program, the addition of a mobile telemonitoring application did not reduce mortality or HF readmissions 6 months after its discontinuation. However, the intervention was associated with sustained improvements in patient empowerment, suggesting a lasting behavioral impact beyond the period of active app use.