Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000212459
Ethics application status
Approved
Date submitted
29/03/2007
Date registered
17/04/2007
Date last updated
17/04/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Can education improve patients' understanding of their cardiac risk?
Scientific title
A randomised trial of the PREDICT programme to improve heart attack patients' understanding of their cardiac risk
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inaccurate understanding of personal cardiac risk 1739 0
Condition category
Condition code
Cardiovascular 1831 1831 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are randomised to receive either the intervention described below plus standard care, or to standard care only. The intervention is a one-off session in addition to standard care. A nurse uses the PREDICT computer programme in an individual session (30 minutes) with hospitalised acute coronary syndrome patients to go through personal risk factors and calculation of personal cardiac risk. The nurse explains the computer printout of personal risk to the patient. PREDICT is the registered trademark of the computer programme.
Intervention code [1] 1674 0
Rehabilitation
Comparator / control treatment
The control group receives standard care only. In standard care, patients receive a visit from a cardiac rehabilitation nurse who provides pamphlets on heart disease and invites patients to attend community rehabilitation classes.
Control group
Active

Outcomes
Primary outcome [1] 2562 0
Accuracy of patients' understanding of their personal cardiac risk. Accuracy is assessed by patients' estimation of personal level of cardiac risk compared to clinical risk estimate by software.
Timepoint [1] 2562 0
At baseline, before discharge, 3 months follow-up
Secondary outcome [1] 4414 0
Correct identification of personal risk factors
Timepoint [1] 4414 0
Measures taken at baseline, before discharge and 3-months.
Secondary outcome [2] 4415 0
Change in illness perceptions.
Timepoint [2] 4415 0
Measures taken at baseline, before discharge and 3-months.
Secondary outcome [3] 4416 0
Change in health behaviours
Timepoint [3] 4416 0
Measures taken at baseline, before discharge and 3-months.
Secondary outcome [4] 4417 0
Change in risk factors
Timepoint [4] 4417 0
Measures taken at baseline, before discharge and 3-months.
Secondary outcome [5] 4418 0
Positive and negative affect
Timepoint [5] 4418 0
Measures taken at baseline, before discharge and 3-months.
Secondary outcome [6] 4419 0
Cardiac Anxiety
Timepoint [6] 4419 0
Measures taken at baseline, before discharge and 3-months.

Eligibility
Key inclusion criteria
Must have been admitted for acute coronary syndrome, must be medically stable.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who can't speak English, are too medically unwell, or who decline consent.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
the assessor and data analyst will be blinded. Patients will not be blinded in this trial.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 499 0
New Zealand
State/province [1] 499 0

Funding & Sponsors
Funding source category [1] 1980 0
Charities/Societies/Foundations
Name [1] 1980 0
New Zealand Heart Foundation
Country [1] 1980 0
New Zealand
Primary sponsor type
Individual
Name
Dr Elizabeth Broadbent
Address
Country
Secondary sponsor category [1] 1793 0
None
Name [1] 1793 0
nil
Address [1] 1793 0
Country [1] 1793 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3678 0
Northern Regional Ethics Committee
Ethics committee address [1] 3678 0
Ethics committee country [1] 3678 0
New Zealand
Date submitted for ethics approval [1] 3678 0
Approval date [1] 3678 0
Ethics approval number [1] 3678 0
NTX/07/02/007

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

Contacts
Principal investigator
Name 27777 0
Address 27777 0
Country 27777 0
Phone 27777 0
Fax 27777 0
Email 27777 0
Contact person for public queries
Name 10863 0
Dr Elizabeth Broadbent
Address 10863 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland
Country 10863 0
New Zealand
Phone 10863 0
+64 9 3737599
Fax 10863 0
Email 10863 0
e.broadbent@auckland.ac.nz
Contact person for scientific queries
Name 1791 0
Dr Elizabeth Broadbent
Address 1791 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland
Country 1791 0
New Zealand
Phone 1791 0
+64 9 3737599
Fax 1791 0
Email 1791 0
e.broadbent@auckland.ac.nz

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.