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

Neubeck L, Redfern J, Briffa T, Bauman A, Hare D, Freedman SB - BMC Cardiovasc Disord (2008)

Bottom Line: CHOICE-plus will also receive additional face-to-face and telephone reinforcement between three and 30 months.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Faculty of Medicine, University of Sydney, Sydney, Australia. lneubeck@med.usyd.edu.au

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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Related in: MedlinePlus

Design of the CHOICE study. ACS: acute coronary syndrome. CHOICE: Choice of Health Options In prevention of Cardiovascular Events.
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Figure 1: Design of the CHOICE study. ACS: acute coronary syndrome. CHOICE: Choice of Health Options In prevention of Cardiovascular Events.

Mentions: This replication study, with a single site randomised control group, with three year follow up will be conducted at four tertiary referral hospitals in Sydney, Australia (figure 1) and is registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12608000182392). Across all four sites patients not accessing standard CR will be randomly allocated to either a group participating in a three month CHOICE program or a 30 month CHOICE program (CHOICE-plus). At one site, patients not accessing CR will be allocated to one of three groups; the previously described intervention groups or a randomised control group participating in conventional care (figure 1), which will allow investigation of the effect of an additional nutrition module and a more tailored approach to depression.


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

Neubeck L, Redfern J, Briffa T, Bauman A, Hare D, Freedman SB - BMC Cardiovasc Disord (2008)

Design of the CHOICE study. ACS: acute coronary syndrome. CHOICE: Choice of Health Options In prevention of Cardiovascular Events.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2572037&req=5

Figure 1: Design of the CHOICE study. ACS: acute coronary syndrome. CHOICE: Choice of Health Options In prevention of Cardiovascular Events.
Mentions: This replication study, with a single site randomised control group, with three year follow up will be conducted at four tertiary referral hospitals in Sydney, Australia (figure 1) and is registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12608000182392). Across all four sites patients not accessing standard CR will be randomly allocated to either a group participating in a three month CHOICE program or a 30 month CHOICE program (CHOICE-plus). At one site, patients not accessing CR will be allocated to one of three groups; the previously described intervention groups or a randomised control group participating in conventional care (figure 1), which will allow investigation of the effect of an additional nutrition module and a more tailored approach to depression.

Bottom Line: CHOICE-plus will also receive additional face-to-face and telephone reinforcement between three and 30 months.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Faculty of Medicine, University of Sydney, Sydney, Australia. lneubeck@med.usyd.edu.au

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].

Show MeSH
Related in: MedlinePlus