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Trial registered on ANZCTR


Registration number
ACTRN12608000182392
Ethics application status
Approved
Date submitted
19/03/2008
Date registered
10/04/2008
Date last updated
18/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The CHOICE (Choice of health options in prevention of cardiovascular events) replication trial.
Scientific title
For patients who survive acute coronary syndrome does the availability of the CHOICE (Choice of health options in prevention of cardiovascular events) program improve the uptake of secondary prevention and reduce the proportion of patients with risk factors above national targets.
Secondary ID [1] 283245 0
Nil
Universal Trial Number (UTN)
Trial acronym
CHOICE (Choice of health options in prevention of cardiovascular events)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndrome 2944 0
Condition category
Condition code
Cardiovascular 3083 3083 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is participation in a 12 month CHOICE program that includes a one-hour initial consultation and a few follow-up phone calls over three months. The program has four stages and was designed as an individualized, structured, case-management approach and was overseen by treating physicians. Stage one involves the development of modules and tailoring of leaflets by thorough investigation of local programs for each risk factor. Stage two involves face-to-face risk factor assessment and measurement, generating a list of each patient’s relevant risk factors. In stage three, patients make guided choices about which risk factors they will lower, participate in goal-setting informed by current national targets for the chosen risk factors, and select which management option(s) they will use to lower risk.

All CHOICE patients participate in a core module for lowering cholesterol (including healthy eating advice and pharmacotherapy) given its major impact on reducing recurrent events. Up to two choice modules including blood pressure-lowering, smoking cessation, increased physical activity and nutrition are also offered depending on individual patient need and preference. After choosing relevant risk factor modules, patient selected their preferred management option(s) and make a self-commitment to a written action plan and are formally referred where appropriate (eg, smoking cessation clinic appointment made). Patients are also provided with a tailored resource package and a summary of the chosen risk factors, goals and interventions is mailed to the family physician, cardiologist and the patient. Stage four of the CHOICE program is telephone follow-up.
Intervention code [1] 2677 0
Prevention
Intervention code [2] 2771 0
Diagnosis / Prognosis
Comparator / control treatment
3 month CHOICE program similar to that described above but with an average of only 4 follow-up telephone calls over 3 months. We will also recruit a randomised control group of approximately 70 participants at one hospital only. This single-site control group will continue to manage their heart health as directed by their treating doctor(s).
Control group
Active

Outcomes
Primary outcome [1] 3969 0
Proportion of patients admitted to hospital with acute coronary syndrome who take up the CHOICE program
Timepoint [1] 3969 0
Baseline, 12 and 36 months after intervention commencement
Primary outcome [2] 3970 0
Difference in mean total cholesterol level between CHOICE and CHOICE-plus groups and from baseline.
Timepoint [2] 3970 0
12 and 36 months
Secondary outcome [1] 6671 0
Poportion of patients achieving National Heart Foundation (NHFA) national target level for blood pressure.
Timepoint [1] 6671 0
12 and 36 months after intervention commencement
Secondary outcome [2] 6672 0
Proportion of patients who achieve smoking cessation
Timepoint [2] 6672 0
12 and 36 months after intervention commencement
Secondary outcome [3] 6673 0
Proportion of patients achieving National Heart Foundation (NHFA) national target level for physical activity
Timepoint [3] 6673 0
12 and 36 months after intervention commencement
Secondary outcome [4] 6674 0
Proportion of patients achieving National Heart Foundation (NHFA) national target level for nutrition
Timepoint [4] 6674 0
12 and 36 months after intervention commencement
Secondary outcome [5] 6675 0
Proportion of patients taking cholesterol-lowering medication
Timepoint [5] 6675 0
12 and 36 months after intervention commencement
Secondary outcome [6] 6676 0
Change in Short Form 12 quality of life scores
Timepoint [6] 6676 0
12 and 36 months after intervention commencement
Secondary outcome [7] 6677 0
Proportion of patients with 3 or more modifiable risk factors
Timepoint [7] 6677 0
12 and 36 months after intervention commencement
Secondary outcome [8] 6840 0
Difference between the single-site control and intervention groups - 3-month and 12-month CHOICE programs.
Timepoint [8] 6840 0
Baseline, 12 and 36 months.

Eligibility
Key inclusion criteria
Diagnosis of ACS in the four weeks prior to recruitment; refusal of the initial invitation to participate in standard CR; failure to attend initial CR assessment.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical diagnosis of uncompensated, severe cardiac failure (Class IV); uncontrolled arrhythmia or angina; severe or symptomatic aortic stenosis; persistent hypotension (SBP < 90mmHg); clinical diagnosis of a severe coexisting medical condition that would prevent participation (eg, dementia, a terminal illness, severe rheumatoid arthritis); or insufficient English to provide written informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After baseline measurements, at 3 hospital sitees, are completed participants will be randomly allocated to one of the two groups (CHOICE or CHOICE-plus). At a single-site, patients will be randomly allocated to one of 3 groups (control, CHOICE or CHOICE-plus). Randomisation will be undertaken by an independent researcher (at the University of Sydney) with a computer-generated random allocation sequence and will be concealed from the health professional obtaining consent and conducting baseline assessment, as management for the first three months will be identical in the two groups. Patients will be coded for confidentiality.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random allocation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This trial will be conducted at 4 hospital sites. At 3 sites patients will be randomly allocated to one of 2 groups (CHOICE, CHOICE-plus) and at 1 site patients will be randomly allocated to one of 3 groups (control, CHOICE, CHOICE-plus).
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 794 0
2000
Recruitment postcode(s) [2] 795 0
2139
Recruitment postcode(s) [3] 797 0
2193
Recruitment postcode(s) [4] 796 0
2200

Funding & Sponsors
Funding source category [1] 3198 0
Charities/Societies/Foundations
Name [1] 3198 0
HCF Health and Medical Research Foundation
Address [1] 3198 0
403 George St, Sydney
Country [1] 3198 0
Australia
Funding source category [2] 3199 0
Government body
Name [2] 3199 0
National Institute of Clinical Studies
Address [2] 3199 0
GPO Box 4530, Melbourne VIC
Level 5, Fawkner Centre
499 St Kilda Road, Melbourne VIC 3004
Country [2] 3199 0
Australia
Primary sponsor type
University
Name
ANZAC Research Institute, Concord Hospital
Address
Hospital Road, Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 2869 0
Other Collaborative groups
Name [1] 2869 0
Sydney South West Area Health Service
Address [1] 2869 0
Suite 108, Medical Centre
Hospital Road Concord NSW 2139
Country [1] 2869 0
Australia
Other collaborator category [1] 239 0
Individual
Name [1] 239 0
Professor Ben Freedman
Address [1] 239 0
Department of Cardiology
Hospital Road Concord NSW 2139
Country [1] 239 0
Australia
Other collaborator category [2] 240 0
Individual
Name [2] 240 0
Dr Tom Briffa
Address [2] 240 0
Clinical Epidemiology, University of Western Australia, Stirling Hwy Crawley WA
Country [2] 240 0
Australia
Other collaborator category [3] 241 0
Individual
Name [3] 241 0
Ms Lis Neubeck
Address [3] 241 0
Suite 108, Medical Centre
Hospital Road Concord NSW 2139
Country [3] 241 0
Australia
Other collaborator category [4] 242 0
Individual
Name [4] 242 0
Associate Professor David Hare
Address [4] 242 0
Austin Hospital
PO Box 5555
Heidelberg, Victoria
Country [4] 242 0
Australia
Other collaborator category [5] 243 0
Individual
Name [5] 243 0
Professor Adrian Bauman
Address [5] 243 0
School of Public Health
University of Sydney, NSW
Country [5] 243 0
Australia
Other collaborator category [6] 244 0
Individual
Name [6] 244 0
Dr Julie Redfern
Address [6] 244 0
Suite 108, Medical Centre
Hospital Road Concord NSW 2139
Country [6] 244 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5182 0
Sydney South West Area Health Service - CRGH Zone
Ethics committee address [1] 5182 0
Concord Hospital, Hospital Road, Concord NSW 2139
Ethics committee country [1] 5182 0
Australia
Date submitted for ethics approval [1] 5182 0
Approval date [1] 5182 0
18/01/2008
Ethics approval number [1] 5182 0
07/CRGH/93

Summary
Brief summary
Sudden heart events are a major health problem and account for about 22% of Australian deaths annually. However, more than 80% of survivors don’t enrol in programs aimed at lowering another attack. We have previously shown that first time survivors who do not use existing cardiac rehabilitation programs have higher coronary risk factors yet were prepared to participate in a brief, guided-choice modular program which resulted in showed significantly improved risk factor level and would lower their chance of a future heart event. The benefit was apparent at 3 months and maintained at 1 year. Given the importance of these findings we aim to determine whether they can be replicated across a range of hospitals and to determine whether periodic reinforcement improves outcomes further and for 3 years.
Trial website
N/A
Trial related presentations / publications
Neubeck L, Redfern J, Briffa T, Bauman A, Hare D, Freedman SB. The CHOICE (Choice of Health Options In prevention of Cardiovascular Events) replication trial: study protocol. BMC Cardiovasc Disord 2008;8(1):25 (01/08/2008)
Neubeck L, Lowres N, Freedman SB, Rogers K, Bauman A, Redfern J. Two year outcomes of the Choice of Health Options In prevention of Cardiovascular Events (CHOICE) replication study. Nursing Prize Session Winner. Cardiac Society of Australia and New Zealand, Gold Coast, Australia (09/08/2013)
Neubeck L, Lowres N, Freedman SB, Briffa T, Bauman A, Redfern J. One year outcomes of the Choice Of Health Options In prevention of Cardiovascular Events (CHOICE) replication trial. EuroPRevent, Rome, Italy (18/04/2013)
Public notes

Contacts
Principal investigator
Name 28451 0
A/Prof Julie Redfern
Address 28451 0
The George Institute for Global Health
83-117 Missenden Road
Camperdown
NSW 2050
Country 28451 0
Australia
Phone 28451 0
+61 2 9993 4574
Fax 28451 0
Email 28451 0
jredfern@georgeinstitute.org.au
Contact person for public queries
Name 11608 0
Dr Lis Neubeck
Address 11608 0
The George Institute for Global Health
83-117 Missenden Road
Camperdown
NSW 2050
Country 11608 0
Australia
Phone 11608 0
+61 417 015 282
Fax 11608 0
Email 11608 0
lneubeck@georgeinstitute.org.au
Contact person for scientific queries
Name 2536 0
Dr Lis Neubeck
Address 2536 0
The George Institute for Global Health
83-117 Missenden Road
Camperdown
NSW 2050
Country 2536 0
Australia
Phone 2536 0
+61 417 015 282
Fax 2536 0
Email 2536 0
lneubeck@georgeinstitute.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary