Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000183381
Ethics application status
Approved
Date submitted
4/04/2008
Date registered
10/04/2008
Date last updated
10/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of patient incentives to improve prevention of ischemic heart disease in general practice
Scientific title
The effectiveness of patient incentives to increase attendance for cardiovascular risk assessment in general practice
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 2994 0
Condition category
Condition code
Cardiovascular 3144 3144 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient incentives for attendance for cardiovascular risk assessment
Patients will be sent a leter of invitation and given six months to attend their general practitioner.
The incentive is a $25 gift voucher.
Intervention code [1] 2735 0
Prevention
Intervention code [2] 2736 0
Behaviour
Intervention code [3] 2756 0
Treatment: Surgery
Comparator / control treatment
no incentive for attendance for cardiovascular risk assessment
Control group
Active

Outcomes
Primary outcome [1] 4028 0
Attendance for cardiovascular risk assessment to the patient's GP
An attendance slip is generated when the risk assessment is performed by the GP. The slip is collected by research staff during regular visits to particpating practices.
The risk assessment is confirmed when the medical record of consenting patients are audited 3-9 months after patients attend for their risk asessment.
Timepoint [1] 4028 0
The outcome is assessed when it occurs. Patients are allowed 6 months in which to attend their GP for a risk assessment. The visit is confirmed by a medical record audit that occurs within 3-9 months of the visit.
Secondary outcome [1] 6785 0
New Zealand absolute cardiovascular risk calculator
Timepoint [1] 6785 0
At the cardiovascular risk assessment.
The data will be obtained by the researcher at the time of the medical note audit 3-9 months after GP risk assessment.
Secondary outcome [2] 6812 0
Absolute cardiovascular risk of patients in the intervention and control groups
Timepoint [2] 6812 0
At the time of the risk assessment

Eligibility
Key inclusion criteria
Attendance at the general practice in the last 12 months
Literate in English
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous diagnosis of heart disease

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)
Concealed allocation
Practice databases were searched to identify patients aged 40-75 years without diagnosed heart disease. GPs reviewed the patient list to exclude those with serious illness, language barriers, or any other reason at the discretion of the GP. The list was further limited to include only one patient per household, by alternately selecting a male or female patient from a shared address. Within each practice eligible patients were allocated a number between 1 and 150 using a random number table.
An independant researcher at a central location determined that patients with numbers 1-60 were assigned to the intervention arm. Patients with numbers 61-150 were assigned to the control arm. Assignment was weighted to the control arm (3:2) because a lower participation rate was expected in this arm.
Patients were sent a letter of invitation to participate in the trial, and to attend their GP for cardiovascular risk assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 641 0
5023
Recruitment postcode(s) [2] 642 0
5086

Funding & Sponsors
Funding source category [1] 3260 0
Charities/Societies/Foundations
Name [1] 3260 0
Royal Australian College of General Practitioners
Country [1] 3260 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace
Adelaide
SA 5005
Country
Australia
Secondary sponsor category [1] 2914 0
None
Name [1] 2914 0
Address [1] 2914 0
Country [1] 2914 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5242 0
The University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 5242 0
Ethics committee country [1] 5242 0
Australia
Date submitted for ethics approval [1] 5242 0
Approval date [1] 5242 0
20/02/2006
Ethics approval number [1] 5242 0
H-020-2006

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28489 0
Address 28489 0
Country 28489 0
Phone 28489 0
Fax 28489 0
Email 28489 0
Contact person for public queries
Name 11646 0
Nigel Stocks
Address 11646 0
Discipline of General Practice
Level 3 Eleanor Harrald Building
Frome Road
The University of Adelaide
SA 5005
Country 11646 0
Australia
Phone 11646 0
08 8303 3460
Fax 11646 0
08 8303 3511
Email 11646 0
[email protected]
Contact person for scientific queries
Name 2574 0
Nigel Stocks
Address 2574 0
Discipline of General Practice
Level 3 Eleanor Harrald Building
Frome Road
The University of Adelaide
SA 5005
Country 2574 0
Australia
Phone 2574 0
08 8303 3460
Fax 2574 0
08 8303 3511
Email 2574 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.