Hybrid comprehensive telerehabilitation in heart failure patients (TELEREH-HF): A randomized, multicenter, prospective, open-label, parallel group controlled trial-Study design and description of the intervention

Abstract

Guidelines recommend exercise training as a component of heart failure (HF) management. There are large disparities in access to rehabilitation and introducing hybrid comprehensive telerehabilitation (TR) consisting of remote monitoring of training in patients' homes might be an optimal solution in Poland.

Purpose: The primary objective of the TELEREH-HF trial is to determine whether introducing TR will significantly increase days alive and out of hospital compared with usual care. The secondary objectives including assessment the effects of TR compared to usual care on all-cause and cardiovascular mortality and all-cause, cardiovascular and HF hospitalization. The tertiary analyses include: evaluation of the safety, effectiveness, quality of life, depression, anxiety, patients' acceptance of and adherence to TR.

Methods: The TELEREH-HF study is a randomized, multicenter, prospective, open-label, parallel group controlled trial in 850 HF patients after a hospitalization incident in NYHA I-III and LVEF≤40%. Patients were randomized to TR + usual care (TR group) or to usual care only (control group) and are followed for a maximum of 24 months. The TR group patients underwent a 9-week TR program consisting of an initial stage (1 week) conducted at hospital and a basic stage (8-week) home-based TR five times weekly.

Results: All patients were randomized and completed initial intervention in the TR group. The follow up of both groups is in progress.

Conclusion: The TELEREH-HF trial will provide novel data on the effects of telerhabilitation on hospitalization and mortality in HF patients, and on safety, quality of life, depression, anxiety and acceptance of and adherence to this intervention.

Trial registration: ClinicalTrials.gov NCT02523560.