A prospective, multicenter, real-world evidence study to examine the effect of individualized follow-up of Smart Phone Application (SPA) based standard of care versus Standard of care among patients with Heart Failure (HF) (Preprint)

BACKGROUND Heart failure (HF) is associated with high morbidity and mortality despite therapeutic advances. Smartphone apps help enhance adherence, early symptom detection, and outcomes. OBJECTIVE To assess the efficacy of a clinical evidence-based SPA (LYFE) in addition to standard of care (SOC) in patients with HF (NYHA II–III). METHODS This was a real-world, multicenter, prospective, two-arm study included Heart Failure (NYHA II–III) patients using a smartphone app with a medical device and standard care to assess 6-month QoL changes via mean Dartmouth COOP scores. The primary endpoint was to assess the change in QoL by mean Darthmouth COOP Questionnaire scores from baseline, at 3-months and 6 months. RESULTS A total of 880 patients were included in this study. Baseline characteristics were comparable. The only MACE observed was revascularization; reported by a single patient in LYFE as well as the SOC group. Compared with SOC, the LYFE group showed significant improvements in weight, BMI, and glycemic control, with stable blood pressure and heart rate. Quality of life improved more in LYFE, across all domains (p