Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000511033
Ethics application status
Approved
Date submitted
30/03/2010
Date registered
21/06/2010
Date last updated
29/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial on the effect of My Health Check, a new interactive web-based decision tool, on the adoption of health preventive behaviours in volunteers aged 30-69 years.
Scientific title
A randomised controlled trial on the effect of My Health Check, a new interactive web-based decision tool, on the adoption of health preventive behaviours in volunteers aged 30-69 years.
Secondary ID [1] 1568 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
This trial does is not aimed at one particular health condition but rather prevention of many conditions which are associated with modifiable lifestyle factors such as lack of exercise or smoking. The two main health conditions preventable by our intervention are cardiovascular disease and cancer. 252065 0
Condition category
Condition code
Public Health 252503 252503 0 0
Health promotion/education
Public Health 257779 257779 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We have developed a web-based decision aid (‘My Health Check’) for 30 to 69 year olds, based on both evidence and personal preferences. Users are asked to complete a questionnaire which includes questions about their age, gender, and health behaviours relevant to My Health Check (up to 10 depending on their age and gender). They are also asked to rate how difficult they would find each health-check activity. Then they are asked to indicate how important each of four attributes (factors determined by focus groups as important when making decisions about preventive health activities) are to them. My health check then displays a list of health behaviours, ranked from greatest potential for gain to least potential for gain. Completing the questionnaire and interactive components of the decision aid could take up to 45 minutes, although this time may vary depending upon the responses to the questionnaire and how many of the links the user clicks on and reads. It must be completed in one go, participants cannot leave it and return later.
Intervention code [1] 241459 0
Behaviour
Intervention code [2] 256692 0
Treatment: Other
Comparator / control treatment
"No treatment" - controls are directed to publicly available websites with standard health information. It is not tailored to the individual’s age, gender and current health behaviours.
Control group
Active

Outcomes
Primary outcome [1] 253138 0
The proportion of the intervention group (intervention = My Health Check(MHC) website) who, three months later, have adopted at least one self-identified health preventive behaviour compared to the proportion of controls who adopt at least one self-identfied health preventative behaviour.
This will be assessed using an online questionnaire. Participants will be sent an email with a link to the questionnaire.
Timepoint [1] 253138 0
3 months after using the 'My Health Check' website
Secondary outcome [1] 262019 0
The proportion of the intervention and control group who indicate they are likely to change their behaviour as a result of either MHC or the standard information. This will be assessed in the online questionnaire following either the intervention.
Timepoint [1] 262019 0
Immediately after using the intervention.
Secondary outcome [2] 262020 0
The proportion of the intervention and control group who indicate they found the information helpful.
This will be assessed in the online questionnaire following intervention.
Timepoint [2] 262020 0
Immediately after visiting the website .
Secondary outcome [3] 262021 0
The proportion of the intervention and control group whose rankings of the top 3 self- identified health preventative behaviour are consistent with maximising health gains.
This will be assessed by comparing the participant's response with what the response would have been if it was based only on the first two attributes (avoid premature death and avoid chronic illness).
Timepoint [3] 262021 0
Immediately after visiting the website.
Secondary outcome [4] 262022 0
The proportion of the intervention group who adopt at least one of the health preventive behaviours based on the one of the top three behavours from the burden of disease data compared with the proportion of controls who adopt one of these behaviours.
Note: this is similar to the primary objective but differs in that the behaviours are not ones which the user has chosen, but the behaviours which will result in the best health outcome.
Timepoint [4] 262022 0
3 months after the intervention.
Secondary outcome [5] 262023 0
The proportion of the intervention and control group who change their top 3 priority behaviours after using th itervention (either MHC or the standard information).
Timepoint [5] 262023 0
Immediately after visiting the website.

Eligibility
Key inclusion criteria
30-69 year olds living in Australia who have a telephone, access to the internet and a reasonable command of the English language.
Minimum age
30 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No access to the internet, insufficient English, younger than 30 years or older than 69 years.

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)
Hunter Valley Research Foundation will recruit 1,100 participants by random digit dialling. Eligible participants who agree to be in the study will be asked a few questions, including their age, gender, mailing and email address. An ID number (from which age group and gender can be determined) will be generated for each participant at the time. They will then be asked to visit the My Health Check website where they can read the Participant Information Sheet and consent for the study online. Once participants have registered and completed the online consent, they will be randomised into either intervention or control groups using an algorithm (developed by the clinical trials centre (CTC)) which will ensure equal distribution of two age groups (under 50, 50 and over) and gender into the intervention and control arms of the study. Participants will then view the appropriate website.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation list for each strata will be prepared according to a permuted blocks approach that will be implemented using a computer-based pseudo-random number generator
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
Active, not recruiting
Date of first participant enrolment
Anticipated
30/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256108 0
Charities/Societies/Foundations
Name [1] 256108 0
NSW Cancer Council
Country [1] 256108 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Lyndal Trevena
Address
Sydney Medical School,
Room 321b, Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 256009 0
None
Name [1] 256009 0
Address [1] 256009 0
Country [1] 256009 0
Other collaborator category [1] 985 0
Individual
Name [1] 985 0
Doctor Siranda Torvaldsen
Address [1] 985 0
Sydney School of Public Health
Room 125, Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country [1] 985 0
Australia
Other collaborator category [2] 1044 0
Individual
Name [2] 1044 0
Professor Jack Dowie
Address [2] 1044 0
London School of Hygiene & Tropical Medicine
University of London
Keppel Street
London WC1E 7HT
Country [2] 1044 0
United Kingdom
Other collaborator category [3] 1045 0
Individual
Name [3] 1045 0
Associate Professor Alexandra Barratt
Address [3] 1045 0
Edward Ford Building (A27)
University of Sydney NSW 2006
Country [3] 1045 0
Australia
Other collaborator category [4] 1046 0
Individual
Name [4] 1046 0
Professor Christopher Del Mar
Address [4] 1046 0
Faculty of Health Sciences & Medicine
Bond University
Gold Cost QLD 4229
Country [4] 1046 0
Australia
Other collaborator category [5] 1047 0
Individual
Name [5] 1047 0
Doctor Timothy Dobbins
Address [5] 1047 0
Integrated Cancer Research Group, Level 1, South Wing, Edmund Blacket Building
Prince of Wales Hospital, Randwick, NSW, 2031
Country [5] 1047 0
Australia
Other collaborator category [6] 1154 0
Individual
Name [6] 1154 0
Doctor Kirsten McCaffery
Address [6] 1154 0
Edward Ford Building (A27)
University of Sydney NSW 2006
Country [6] 1154 0
Australia
Other collaborator category [7] 1299 0
Individual
Name [7] 1299 0
Doctor Camille Raynes-Greenow
Address [7] 1299 0
Sydney School of Public Health
Room 125, Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country [7] 1299 0
Australia
Other collaborator category [8] 1300 0
Individual
Name [8] 1300 0
Ms Mbathio Dieng
Address [8] 1300 0
Sydney School of Public Health
Room 125, Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country [8] 1300 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258193 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 258193 0
Level 6
Jane Foss Russell Building (G02)
The University of Sydney,
NSW 2006
Ethics committee country [1] 258193 0
Australia
Date submitted for ethics approval [1] 258193 0
Approval date [1] 258193 0
17/12/2009
Ethics approval number [1] 258193 0
12293

Summary
Brief summary
We have developed a web-based decision aid (‘My Health Check’) for 30 to 69 year olds, based on both evidence and personal preferences. Users are asked to complete a questionnaire which includes questions about their age, gender, and health behaviours relevant to My Health Check (up to 10 depending on their age and gender). They are also asked to rate how difficult they would find each health-check activity. Then they are asked to indicate how important each of four attributes (factors determined by focus groups as important when making decisions about preventive health activities) are to them. My health check then displays a list of health behaviours, ranked from greatest potential for gain to least potential for gain. This study will determine whether or not users of My Health Check are more likely to adopt health preventive behaviours than people who are just shown the standard information on the web.
Trial website
http://myhealthcheck.health.usyd.edu.au/
Trial related presentations / publications
1. Torvaldsen S, Trevena L, Rosas M and Dowie J. ‘Using burden of disease data to inform consumers’ health decision making’. The 2009 AEA Annual Scientific Meeting, Dunedin, New Zealand.

2. Trevena LJ, Torvaldsen S, Dowie J, McCaffery K, Barratt A, Del Mar C, Dobbins T, Kearney B. 'A web-based application of multi-criteria decision analysis for prioritising preventive healthcare options.' 5th International Shared Decision Making Conference, Boston, USA, June 2009.
Public notes

Contacts
Principal investigator
Name 30422 0
Address 30422 0
Country 30422 0
Phone 30422 0
Fax 30422 0
Email 30422 0
Contact person for public queries
Name 13669 0
Camille Raynes-Greenow
Address 13669 0
Sydney School of Public Health
Room 125, Edward Ford Building (A27)
The University of Sydney NSW 2006
Country 13669 0
Australia
Phone 13669 0
+61 2 9351 6591
Fax 13669 0
+61 2 9351 5049
Email 13669 0
[email protected]
Contact person for scientific queries
Name 4597 0
Camille Raynes-Greenow
Address 4597 0
Sydney School of Public Health
Room 125, Edward Ford Building (A27)
The University of Sydney NSW 2006
Country 4597 0
Australia
Phone 4597 0
+61 2 9351 6591
Fax 4597 0
+61 2 9351 5049
Email 4597 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
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