Applying telemedicine technologies in a novel model of organizing and implementing comprehensieve cardiac rehabilitation in heart failure patients - TELEREH-HF study.
Hybrid comprehensive TELEREHabilitation in Heart Failure - TELEREH-HF study is co-financed by National Center for Research and Development in the Strategic Program Prevension and Therapy of Civilization-Related Diseases – STRATEGMED.
Project TELEREH-HF is conducted by Polish interdisciplinary Consortium: Telecardiology Center, Institute of Cardiology, Warsaw – Leader of the Project,
Silesian Center for Heart Diseases Zabrze, Medical University of Gdańsk, Medical University of Łódź, Medical University of Warsaw, Pro-PLUS SA, Warsaw.
The study is designed as a randomized, prospective, open-label, parallel group, controlled, multi-center trial among 850 clinically stable heart failure patients (in 2015-2020).
Project Objective: To apply telemedicine technologies to implement a novel model of home-based cardiac comprehensive rehabilitation in heart failure patients (NYHA I-III, LVEF≤40%) after a cardiovascular hospitalization incydent.
Methods. Eligible patients are randomized (1:1) to either hybrid telerehabilitation plus telecare group or to usual care group. The telerehabilitation group undergo a 9-week hybrid telerehabilitation program consisting of an initial stage (1 week) conducted at hospital and a basic stage (8-week) home-based telerehabilitation five times weekly. The usual care group receive usual care appropriate for their clinical status and standardized within a particular center.
All 850 patients undergo the following assessments at entry and after completing the 9-week program: clinical examination with symptom evaluation (NYHA class), lab tests, ECG, echocardiography, 6-minute walk test, cardiopulmonary exercise treadmill test, 24 hours holter ECG monitoring, cardiovascular implantable electronic devices (CIEDs) proper functioning evaluation, and psychological assessment: health-related quality of life, depression and anxiety. The remote monitoring of CIEDs parameters is carried out in the study group for 9 weeks.
Results. During the 24-month follow-up, both groups will assess the primary endpoint (days alive and out of hospital) and secondary endpoints (all-cause and cardiovascular mortality and all-cause, cardiovascular and heart failure hospitalization as well as the effectiveness, safety, acceptance of and adherence to hybrid comprehensive telerehabilitation).
The project will enable early secondary prevention in the population of patients with heart failure to be implemented. It will be achieved via:
– novel concept – “From Hospital To Home”
– novel technology – telemedicine
– novel method of comprehensive cardiac rehabilitation implementation.