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

BMC Cardiovascular Disorders

Study Protocol

Emeline M. Van Craenenbroeck¹  Christiaan Vrints¹  Dominique Hansen²  Paul Dendale³  Ines Frederix³  Pieter Vandervoort⁴  Karin Coninx⁵ 

[1] Department of Cardiology, Antwerp University Hospital, Wilrijkstraat 10, 2650, Edegem, Belgium;Department of Cardiology, Jessa Hospital, Stadsomvaart 11, 3500, Hasselt, Belgium;Department of Cardiology, Jessa Hospital, Stadsomvaart 11, 3500, Hasselt, Belgium;Faculty of Medicine & Life Sciences, Hasselt University, Agoralaan gebouw D, 3590, Diepenbeek, Belgium;Faculty of Medicine & Life Sciences, Hasselt University, Agoralaan gebouw D, 3590, Diepenbeek, Belgium;Department of Cardiology, Hospital East-Limburg, Schiepse Bos 6, 3600, Genk, Belgium;Faculty of Sciences, Expertise Center for Digital Media, Hasselt University, Wetenschapspark 2, 3590, Diepenbeek, Belgium;

关键词: Cardiac telerehabilitation;    Cardiovascular disease;    Intervention trial;    Telemonitoring and telecoaching;   

DOI  :  10.1186/s12872-015-0021-5

 received in 2015-01-28, accepted in 2015-04-15,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundTelerehabilitation 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/DesignIn 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 1:1 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.DiscussionTelerehab 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 registrationCurrent controlled trials ISRCTN29243064. Registration date 21 January 2015.

【 授权许可】

CC BY   
© Frederix et al.; licensee BioMed Central. 2015