SMARTphone and social media-based Cardiac Rehabilitation and Secondary Prevention (SMART-CR/SP) for patients with coronary heart disease in China: a randomised controlled trial protocol.

INTRODUCTION

The burden of cardiovascular disease (CVD) is rapidly increasing in developing countries, however access to cardiac rehabilitation and secondary prevention (CR/SP) in these countries is limited. Alternative delivery models that are low-cost and easy to access are urgently needed to address this service gap. The objective of this study is to investigate whether a smartphone and social media-based (WeChat) home CR/SP programme can facilitate risk factor monitoring and modification to improve disease self-management and health outcomes in patients with coronary heart disease (CHD), after percutaneous coronary intervention (PCI) therapy.

METHODS AND ANALYSIS

We propose a single-blind, randomised controlled trial of 300 patients post-PCI with follow-up over 12 months. The intervention group will receive a smartphone-based and WeChat-based CR/SP programme providing education and support for risk factor monitoring and modification. SMART-CR/SP incorporates core components of modern CR/SP: physical activity tracking with interactive feedback and goal setting; education modules addressing CHD understanding and self-management; remote blood pressure monitoring and strategies to improve medication adherence. Furthermore, a dedicated data portal and a CR/SP coach will facilitate individualised supervision and counselling. The control group will receive usual care but no formal CR/SP programme. The primary outcome is change in exercise capacity measured by 6 minute walk test distance. Secondary outcomes include knowledge and awareness of CHD, risk factor status, medication adherence, psychological well-being and quality of life, major cardiovascular events, re-hospitalisations and all-cause mortality. To assess the feasibility and patients' acceptance of the intervention, a process evaluation will be performed at the conclusion of the study.

ETHICS AND DISSEMINATION

Ethics approval was granted by both the Human Research Ethics Committee of Fudan University Zhongshan Hospital (HREC B2016-058) and Curtin University Human Research Ethics Office (HRE2016-0120). Results will be disseminated via peer-reviewed publications and presentations at conferences.

CLINICAL TRIAL REGISTRATION NUMBER

ChiCTR-INR-16009598; Pre-results.