Study protocol

The CHOICE (Choice of Health Options In prevention of Cardiovascular Events) replication trial: study protocol

Lis Neubeck^1,2 , Julie Redfern^2,3 , Tom Briffa⁴ , Adrian Bauman⁵ , David Hare⁶ and SB Freedman^1,2,7

¹Faculty of Medicine, University of Sydney, Sydney, Australia

²ANZAC Research Institute, Concord Hospital, Sydney, Australia

³NHMRC NICS-Heart Foundation Fellow, Melbourne, Australia

⁴School of Population Health, University of Western Australia, Perth, Australia

⁵School of Public Health, University of Sydney, Sydney, Australia

⁶Department of Cardiology, Austin Health, Department of Medicine, University of Melbourne, Melbourne, Australia

⁷Department of Cardiology, Concord Repatriation General Hospital, Sydney, Australia

author email corresponding author email

BMC Cardiovascular Disorders 2008, 8:25doi:10.1186/1471-2261-8-25

Published:	6 October 2008

Abstract

Background

Although morbidity and mortality from coronary heart disease (CHD) are high, only a minority of acute coronary syndrome (ACS) survivors accesses an effective secondary prevention program. We aim to determine whether the previously proven CHOICE program can be replicated at multiple sites and whether ongoing reinforcement further improves risk factor modification.

Methods/design

Participants eligible for but not accessing standard cardiac rehabilitation will be randomly allocated to either a previously tested 3-month CHOICE program or a 30-month CHOICE program (CHOICE-plus). Both groups will participate in individualised risk factor modules of differing duration that involve choice, goal setting and telephone follow-up for three months. CHOICE-plus will also receive additional face-to-face and telephone reinforcement between three and 30 months. At one site we will recruit a randomised control group, receiving conventional care. Primary outcomes are lipid levels, blood pressure, physical activity levels and smoking rates. Secondary outcomes include readmission rates, death, the number of risk factors, other modifiable risk factors, quality of life and process evaluation measures over three years.

Discussion

We present the rationale and design of a multi-centre, replication study testing a modular approach for the secondary prevention of CHD following an ACS.

Trial Registration

[Clinical Trial Registration Number, ACTRN12608000182392]