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Randomized Controlled Trial
. 2008 Oct 6:8:25.
doi: 10.1186/1471-2261-8-25.

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

Lis Neubeck  1 , Julie Redfern, Tom Briffa, Adrian Bauman, David Hare, S B Freedman
Affiliations
Randomized Controlled Trial

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

Lis Neubeck et al. BMC Cardiovasc Disord. .

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].

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Figures

Figure 1
Figure 1
Design of the CHOICE study. ACS: acute coronary syndrome. CHOICE: Choice of Health Options In prevention of Cardiovascular Events.
Figure 2
Figure 2
Model of CHOICE (Choice of Health Options In prevention of Cardiovascular Events) program after acute coronary syndrome (ACS).
See this image and copyright information in PMC

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