Non-invasive home telemonitoring system for heart failure patients: A randomized clinical trial

Abstract

Introduction: The low quality of life in heart failure patients is related to low self-care and treatment adherence. Consequently, innovative strategies are needed to improve them. The objective of this work is to determine the effectiveness of the use of a home telemonitoring system to improve the self-care and treatment adherence of heart failure patients.

Methods: A randomized clinical trial that compares the efficacy of a home telemonitoring system -intervention group versus usual care control group - among heart failure outpatients over a 90-day monitoring period was carried out. The home telemonitoring system consists of an application that collects measurements of different parameters on a daily basis and provides health education to patients. The home telemonitoring system processes data gathered and generates an alert if a risky situation arises. The outcomes observed were significant changes in patients' self-care (European Heart Failure Self-care Behaviour Scale), treatment adherence (Morisky Modified Scale) and re-hospitalizations over the follow-up period.

Results: 104 heart failure patients were screened; 40 met the inclusion criteria; only 30 completed the study. After the follow-up, intragroup analysis of the control group indicated a decrease in treatment adherence (p = 0.02). The mean European Heart Failure Self-care Behaviour Scale overall score indicated an improved self-care in the intervention group patients (p = 0.03) and a worsened self-care in the control group (p = 0.04) with a p value of 0.004 in the intergroup analysis. Thanks to the home telemonitoring system alerts, two re-hospitalizations were avoided.

Discussion: This study demonstrated that the proposed home telemonitoring system improves patient self-care when compared to usual care and has the potential to avoid re-hospitalizations, even considering patients with low literacy levels.Trial Registration: Home Telemonitoring System for Patients with Heart Failure. clinicaltrials.gov Identifier: NCT04071093.

Keywords: Telemedicine; clinical trial; e-health; heart failure; self-care.