Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000108011
Ethics application status
Not yet submitted
Date submitted
28/01/2010
Date registered
2/02/2010
Date last updated
2/02/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the impact of the 'Your Heart Forecast' Tool on smokers' understanding of their cardiovascular disease risk and their motivation to make lifestyle changes.
Scientific title
An evaluation of the impact of the 'Your Heart Forecast' Tool on smokers' understanding of their cardiovascular disease risk and their motivation to make lifestyle changes.
Secondary ID [1] 1359 0
Nil
Universal Trial Number (UTN)
U1111-1113-5109
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovasular disease 256702 0
Condition category
Condition code
Cardiovascular 256855 256855 0 0
Coronary heart disease
Public Health 256884 256884 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 'Your Heart Forecast' tool, an electronic tool that was developed to help doctors explain cardiovascular risk to their patients and encourage them to make important lifestyle changes. Administered by the patient's doctor or practice nurse, the Heart Forecast Tool provides a graphical story, starting with a patient's current cardiovascular risk, and showing them how they compare to a peer with ideal risk factor control and the same cardiovascular risk. The tool then shows patients what happens to their risk as they get older and make no changes to their current risk factors (their Heart Forecast), and then what would happen to their risk in the future if they were able to make changes (eg. stop smoking). The Heart Forecast takes 5-10 minutes to administer and can be downloaded free via this website address: http://www.yourheartforecast.org.nz/index.asp?pageID=2145872462
Participants allocated to this intervention group also undergo the 'usual risk assessment' in addition to the Heart Forecast tool.
Intervention code [1] 255935 0
Behaviour
Intervention code [2] 255951 0
Prevention
Comparator / control treatment
The comparator intervention is 'usual risk assessment', which involves estimating the participant's 5 year cardiovascular disease risk using flip charts. Like the group receiving the Heart Forecast tool intervention, this group would receive the assessment face-to-face with the study coordinator (either a study nurse or General Practice [GP] registrar). The approximate duration of the assessment (which includes completing pre- and post-assessment questionnaires) will be no more than 60 minutes
Control group
Active

Outcomes
Primary outcome [1] 257726 0
Improvement in participants' motivation to make appropriate lifestyle changes. This will be assessed using a structured questionnaire.
Timepoint [1] 257726 0
Immediately post-intervention and 1 month later
Primary outcome [2] 257727 0
Improvement in participants' understanding of:
(1) their short- and longer-term cardiovascular risk
(2) how lifestyle change can reduce risk in the short- and long-term
(3) their own individual cardiovascular risk factors

This will be assessed using a structured questionnaire.
Timepoint [2] 257727 0
Immediately post-intervention and 1 month later
Secondary outcome [1] 263088 0
nil
Timepoint [1] 263088 0
nil

Eligibility
Key inclusion criteria
Smokers aged 30-65 years
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with clinically high risk, as defined by New Zealand Guidelines Group criteria - ie. if they have any of the following:
- previous cardiovascular disease
- stroke or transient ischaemic attack (TIA)
- diabetes complicated by renal disease
- a genetic lipid disorder
- blood pressure 170/100 or over
- total cholesterol or total cholesterol/high density lipoprotein ratio (TC/HDL) 8 or over
- pregnant

Also, non-English speakers would be excluded as the Forecast tool is available in English language version only

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)
Potential participants will be identified from practice databases. The study nurse will contact people meeting eligibility criteria and invite them to join the study.

Allocation concealment will be achieved via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation of intervention (to either 'usual risk assessment' or 'usual risk assessment plus Heart Forecast') will be via generation of random numbers (this will be via simple randomisation using a randomisation table created by computer software). Numbers will be considered as random digits from 0 to 9, with odd numbers representing randomisation to 'usual risk assessment' and even numbers indicating allocation to 'usual risk assessment plus Heart Forecast'.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2010
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] 2448 0
New Zealand
State/province [1] 2448 0
Southland

Funding & Sponsors
Funding source category [1] 256429 0
Charities/Societies/Foundations
Name [1] 256429 0
National Heart Foundation of New Zealand
Country [1] 256429 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Section of Epidemiology and Biostatistics
School of Population Health
Tamaki Campus
University of Auckland
PO Box 92-019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 255733 0
Charities/Societies/Foundations
Name [1] 255733 0
National Heart Foundation of New Zealand
Address [1] 255733 0
PO Box 17-160
Greenlane
Auckland 1546
Country [1] 255733 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258485 0
Lower South Regional Ethics Committee
Ethics committee address [1] 258485 0
PO Box 5849
Dunedin 9058
Ethics committee country [1] 258485 0
New Zealand
Date submitted for ethics approval [1] 258485 0
07/02/2010
Approval date [1] 258485 0
Ethics approval number [1] 258485 0

Summary
Brief summary
‘Your Heart Forecast’ is an electronic tool that was developed to help doctors explain cardiovascular risk to their patients and encourage them to make important lifestyle changes. The Heart Forecast was piloted in over 40 practices in Auckland and Northland in early 2009. Feedback was positive, indicating that the tool supported cardiovascular risk communication and shared decision making. The current study aims to more formally test the efficacy of the Heart Forecast, examining whether it improves patients’ understanding of the determinants of their risk and helps motivate them to make necessary lifestyle changes. One hundred patients aged 30-65 who are current smokers will be recruited on to this study. They will be randomised to receive one of two interventions: either usual risk assessment or usual risk assessment plus the Heart Forecast. Changes in understanding and motivation will be assessed via questionnaires immediately pre- and post, and 1-month post, their intervention sessions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30781 0
Address 30781 0
Country 30781 0
Phone 30781 0
Fax 30781 0
Email 30781 0
Contact person for public queries
Name 14028 0
Dr Andrew Kerr
Address 14028 0
Department of Cardiology
Middlemore Hospital
Private Bag 933111
Otahuhu
Auckland
Country 14028 0
New Zealand
Phone 14028 0
+649 2760000
Fax 14028 0
+649 2709746
Email 14028 0
[email protected]
Contact person for scientific queries
Name 4956 0
Dr Andrew Kerr
Address 4956 0
Department of Cardiology
Middlemore Hospital
Private Bag 933111
Otahuhu
Auckland
Country 4956 0
New Zealand
Phone 4956 0
+649 2760000
Fax 4956 0
+649 2709746
Email 4956 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.