Empowering patients with heart failure: a digital health solution improved self-care and metabolic outcomes in a randomized controlled trial

Abstract Background/Introduction Heart failure is a common cause of morbidity and mortality and poses a significant burden on patients and healthcare providers. Purpose The aim of the study was to evaluate whether a digital health program improves quality of life and clinical outcomes for patients with heart failure. Methods A single-center, randomized controlled trial (RCT) was conducted with patients receiving standard of care (SoC) at a heart failure outpatient clinic. Patients were randomized (1:1) to receive either SoC alone or SoC with an additional six-month digital health program. The program consisted of remote patient monitoring (RPM) with symptom tracking, disease-specific education, and lifestyle coaching, designed to empower patients with heart failure. After the main program concluded, a six-month maintenance program was initiated, consisting of recurrent educational materials, with reduced coaching- and RPM frequency. The primary endpoint was the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) at six months. Secondary endpoints included the European Heart Failure Self-care Behaviour Scale-9 (EHFScB-9), 6-question heart failure knowledge questionnaire, and metabolic outcomes. Here we report on the Intention-to-Treat (ITT) population analysis for the primary and significant secondary endpoints at six and 12 months. Results The ITT included 175 participants, 86 in the program group and 89 in the control. Program group: mean age (SD) 64.7 (13.2), 66.3% male, 87.2% with NYHA stages I-II. Control group: mean age (SD) 66.2 (11.1) years, 69.7% male, 87.6% with NYHA stages I-II. Median compliance with RPM was 93% and in-app retention was 80% at six months. Results for primary and secondary endpoints are presented in Table 1 and Figure 1. No statistical difference was observed in the KCCQ score between groups at six or 12 months. The program group had statistically significant improvements in EHFScB-9 score at six and 12 months and in heart failure knowledge at 12 months compared to the control group. Metabolic outcomes: a significant difference in glucose levels was also observed between groups at six months, and in HbA1c and triglycerides levels at 12 months. Conclusions The difference between groups in the primary endpoint of heart failure symptoms and quality of life, as measured by the KCCQ-12, was not statistically significant. However, significant differences were observed in self-care behaviour and heart failure knowledge, as well as metabolic outcomes at six and 12 months, when compared with standard care alone. These findings, along with good retention and engagement, indicate the value to patients of digital health interventions in the management of heart failure.