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Original Investigation
November 17, 2019

Effects of a 9-Week Hybrid Comprehensive Telerehabilitation Program on Long-term Outcomes in Patients With Heart Failure: The Telerehabilitation in Heart Failure Patients (TELEREH-HF) Randomized Clinical Trial

Author Affiliations
  • 1Telecardiology Center, Institute of Cardiology, Warsaw, Poland
  • 2Duke University School of Medicine, Durham, North Carolina
  • 3Department of Cardiology, Medical University of Warsaw, Warsaw, Poland
  • 4University of Rochester Medical Center, Rochester, New York
  • 5Department of Hypertension, Medical University of Łódź, Łódź, Poland
  • 6Institute of Cardiology, Warsaw, Poland
  • 7Department of Rehabilitation Medicine, Medical University of Gdańsk, Gdańsk, Poland
  • 8Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Silesian Center for Heart Diseases, Silesian Medical University, Zabrze, Poland
  • 9Department of Internal Medicine and Cardiac Rehabilitation, Medical University of Łódź, Łódź, Poland
  • 10Department of Arrhythmia, Institute of Cardiology, Warsaw, Poland
  • 11Department of Cardiology and Electrotherapy, Medical University of Gdańsk, Gdańsk, Poland
  • 12Department of Medical Informatics and Telemedicine, Medical University of Warsaw, Warsaw, Poland
  • 13Department of Cardiac Rehabilitation and Noninvasive Electrocardiology, Institute of Cardiology, Warsaw, Poland
  • 14Deputy Editor for Statistics, JAMA Cardiology
JAMA Cardiol. Published online November 17, 2019. doi:https://doi.org/10.1001/jamacardio.2019.5006
Key Points

Question  Does a 9-week hybrid comprehensive cardiac telerehabilitation program, compared with usual care, improve the percentage of days that patients with heart failure spend alive and out of the hospital during long-term follow-up?

Findings  This multisite randomized clinical trial of 850 patients assigned to hybrid comprehensive telerehabilitation or usual care did not meet its primary outcome of extending the percentage of days alive and out of the hospital during 14 to 26 months of follow-up.

Meaning  In this trial, a 9-week hybrid comprehensive telerehabilitation program in patients with heart failure did not increase the percentage of days alive and out of the hospital during 14 to 26 months of follow-up.

Abstract

Importance  Guidelines recommend exercise training as a component of heart failure management. There are large disparities in access to rehabilitation, and introducing hybrid comprehensive telerehabilitation (HCTR) consisting of remote monitoring of training at patients’ homes might be an appealing alternative.

Objective  To assess whether potential improvements in quality-of-life outcomes after a 9-week HCTR intervention in patients with heart failure translate into improvement in clinical outcomes during extended 12 to 24 months of follow-up, compared with usual care.

Design, Setting, and Participants  The Telerehabilitation in Heart Failure Patients (TELEREH-HF) trial is a multicenter, prospective, open-label, parallel-group randomized clinical trial that enrolled 850 patients with heart failure up to 6 months after a cardiovascular hospitalization with New York Heart Association levels I, II, or III and left ventricular ejection fraction of 40% or less. Patients from 5 centers in Poland were randomized 1:1 to HCTR plus usual care or usual care only and followed up for 14 to 26 months after randomization.

Interventions  During the first 9 weeks, patients underwent either an HCTR program (1 week in hospital and 8 weeks at home) or usual care with observation. The HCTR intervention encompassed telecare, telerehabilitation, and remote monitoring of implantable devices. No intervention occurred in the remaining study period.

Main Outcomes and Measures  The percentage of days alive and out of the hospital from randomization through the end of follow-up at 14 to 26 months.

Results  A total of 850 patients were enrolled, with 425 randomized to the HCTR group (377 male patients [88.7%]; mean [SD] age, 62.6 [10.8] years) and 425 randomized to usual care (376 male patients [88.5%]; mean [SD] age, 62.2 [10.2] years). The HCTR intervention did not extend the percentage of days alive and out of the hospital. The mean (SD) days were 91.9 (19.3) days in the HCTR group vs 92.8 (18.3) days in the usual-care group, with the probability that HCTR extends days alive and out of the hospital equal to 0.49 (95% CI, 0.46-0.53; P = .74) vs usual care. During follow-up, 54 patients died in the HCTR arm and 52 in the usual-care arm, with mortality rates at 26 months of 12.5% vs 12.4%, respectively (hazard ratio, 1.03 [95% CI, 0.70-1.51]). There were also no differences in hospitalization rates (hazard ratio, 0.94 [95% CI, 0.79-1.13]). The HCTR intervention was effective at 9 weeks, significantly improving peak oxygen consumption (0.95 [95% CI, 0.65-1.26] mL/kg/min vs 0.00 [95% CI, −0.31 to 0.30] mL/kg/min; P < .001) and quality of life (Medical Outcome Survey Short Form–36 questionnaire score, 1.58 [95% CI, 0.74-2.42] vs 0.00 [95% CI, −0.84 to 0.84]; P = .008), and it was well tolerated, with no serious adverse events during exercise.

Conclusions and Relevance  In this trial, the positive effects of a 9-week program of HCTR in patients with heart failure did not lead to the increase in percentage of days alive and out of the hospital and did not reduce mortality and hospitalization over a follow-up period of 14 to 26 months.

Trial Registration  ClinicalTrials.gov identifier: NCT02523560

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