Previously submitted to: JMIR Cardio (no longer under consideration since May 11, 2026)
Date Submitted: Jan 12, 2026
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
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)
ABSTRACT
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<0.050). Functional capacity gains were greater, with reduced rest duration and fewer stops on the 6-minute walk test. Hospitalizations were fewer in LYFE (1 vs 2). Adherence to medication and diet was significantly higher at 1 and 3 months (p<0.001).
Conclusions:
SPA-based remote monitoring integrated with SOC improved self-management, adherence, functional outcomes, and quality of life in HF patients. Larger, longer-term studies are needed to confirm impact on hard cardiovascular outcomes.
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