Evaluation of a smartphone app for heart failure patients : for ProCarement GmbH

Objective: Heart failure (HF) is a prevalent condition affecting millions of individuals worldwide. Continuous monitoring and targeted behavioral interventions have been shown to improve health status and quality of life for HF patients. Digital therapeutics offer the possibility to make more frequent monitoring and targeted behavioral interventions available for more people. The ProHerz app aims to support patients suffering from HF using easy-to-use monitoring of medical parameters for early detection of disease progression as well as self-help features. This report presents results from a randomized controlled trial (RCT) to assess the impact of the app. Methods: An RCT with 252 HF patients was conducted where half of patients received access to a digital therapeutic (ProHerz). Clinical indicators as well as patient-reported outcomes were collected at entry and exit examinations. We conduct statistical analyses with and without covariate adjustment and using different imputation strategies for missing values. Results: We find significant positive effects of the intervention on 6-minute walk test distance (6MWT), self-care behavior (EHFScBS score) and HF-specific health literacy (number of correct answers in AHFKT). The intervention group also showed better progression in NYHA class compared to the control group. Conclusion: Patients assigned to use the app experienced significant improvements in their condition. The statistical analysis is robust to different sensitivity analyses.