Telerehab III: a multi-center randomized, controlled trial investigating the long-term effectiveness of a comprehensive cardiac telerehabilitation program--rationale and study design.

ABSTRACT

BACKGROUND: Telerehabilitation has been proposed as an adjunct/alternative to standard center-based cardiac rehabilitation. Two recent systematic reviews showed non-inferiority and/or superiority of this remote approach for cardiac rehabilitation. However, these trials focused only on one core component of cardiac rehabilitation and telemonitoring, rather than implementing a more comprehensive approach. The aim of Telerehab III is to investigate the long-term effectiveness of the addition of a patient-tailored, internet-based telerehabilitation program implementing multiple cardiac rehabilitation core components and using both telemonitoring and telecoaching strategies to standard cardiac rehabilitation. METHODS/DESIGN: In this prospective, multi-center randomized, controlled trial 140 patients with coronary artery disease and/or chronic heart failure patients will be recruited between February 2013 and February 2015. Patients will be randomized 11 to an intervention group (receiving an internet-based telerehabilitation program in addition to standard cardiac rehabilitation) or to standard cardiac rehabilitation alone. The mean follow-up is at least 6 months. The primary endpoint is peak oxygen consumption (VO2 peak). Secondary endpoints include measured and self-reported daily physical activity, cardiovascular risk factor control, health-related quality of life, days lost due to (non)cardiovascular rehospitalizations and time to first (non)cardiovascular rehospitalization. A clinical event committee blinded to treatment allocation assesses causes of rehospitalizations. DISCUSSION: Telerehab III will be one of the first studies to examine the added value of a more comprehensive cardiac telerehabilitation program, focusing on multiple cardiac rehabilitation core components. It has the potential to augment current standard center-based cardiac rehabilitation practices and to be used as a model for other disease prevention programs. TRIAL REGISTRATION Current controlled trials ISRCTN29243064. Registration date 21 January 2015.