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Trial registered on ANZCTR
Registration number
ACTRN12625000551493
Ethics application status
Approved
Date submitted
14/05/2025
Date registered
30/05/2025
Date last updated
8/06/2025
Date data sharing statement initially provided
30/05/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Does it matter which health professional gives advice to exercise for knee osteoarthritis (OA)? An online randomised controlled trial.
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Scientific title
Does it matter which health professional gives advice to exercise for knee osteoarthritis (OA)? An online randomised controlled trial evaluating effects on beliefs about exercise and physical activity.
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Secondary ID [1]
314317
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
osteoarthritis
337269
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Condition category
Condition code
Musculoskeletal
333669
333669
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0
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Osteoarthritis
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Public Health
333937
333937
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The entire trial will be administered in one single online survey.
Eligible participants will be asked to imagine a hypothetical scenario where they have developed chronic knee pain and made an appointment with a healthcare professional to find out what is wrong and how to treat it. Participants will then be automatically randomised by Qualtrics to one of three groups, all of whom will be asked to watch a pre-recorded ~2 minute video where they receive an:
i) Exercise recommendation from a physiotherapist.
ii) Exercise recommendation from a GP.
iii) Exercise recommendation from an orthopaedic surgeon.
The content of all three videos will be identical and delivered by the same person, but participants will be told that they are a different type of healthcare professional. In all scenarios, the healthcare professional will provide an evidence-based explanation of what osteoarthritis is, its prognosis, and how it can be managed. The healthcare professional will then recommend commencing an exercise program first before exploring other treatment options. They will describe the benefits of exercise and its safety for people with osteoarthritis. Participants will be required to confirm (via checkbox) that they had watched the whole video before completing outcome measures. Participants will complete outcome measures immediately after watching their allocated video.
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Intervention code [1]
330926
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Treatment: Other
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Intervention code [2]
331142
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Behaviour
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Comparator / control treatment
This is a three arm study, with the three groups described above. The reference comparator will be group 1, which will receive a recommendation to exercise from a physiotherapist.
We will also evaluate potential moderators of effects on the primary outcome (e.g., current knee pain or not, sex, and age).
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Control group
Active
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Outcomes
Primary outcome [1]
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Belief about exercise and physical activity (composite outcome)
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Assessment method [1]
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11-point NRS ranging from 0=not beneficial to 10=highly beneficial
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Timepoint [1]
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Single survey study - will be assessed immediately after the intervention
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Secondary outcome [1]
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Trustworthiness of healthcare professional
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Assessment method [1]
446955
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11-point NRS ranging from 0=not at all trustworthy to 10=very trustworthy
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Timepoint [1]
446955
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Single survey study - will be assessed immediately after the intervention
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Secondary outcome [2]
446947
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Belief about safety of exercise and physical activity (composite outcome)
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Assessment method [2]
446947
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11-point NRS ranging from 0=definitely would not damage it to 10=definitely would damage it
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Timepoint [2]
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Single survey study - will be assessed immediately after the intervention
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Secondary outcome [3]
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Confidence
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Assessment method [3]
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11-point NRS ranging from 0=not at all confident to 10=very confident
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Timepoint [3]
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Single survey study - will be assessed immediately after the intervention
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Secondary outcome [4]
446950
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Belief about medication
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Assessment method [4]
446950
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11-point NRS ranging from 0=not beneficial to 10=highly beneficial
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Timepoint [4]
446950
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Single survey study - will be assessed immediately after the intervention
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Secondary outcome [5]
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Belief about joint replacement surgery
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Assessment method [5]
446949
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11-point NRS ranging from 0=definitely not necessary to 10=definitely necessary
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Timepoint [5]
446949
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Single survey study - will be assessed immediately after the intervention
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Secondary outcome [6]
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Likelihood to seek a second opinion
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Assessment method [6]
446953
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11-point NRS ranging from 0=not at all likely to 10=very likely
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Timepoint [6]
446953
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Single survey study - will be assessed immediately after the intervention
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Secondary outcome [7]
446948
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Intentions to start exercising
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Assessment method [7]
446948
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11-point NRS ranging from 0=extremely unlikely to 10=extremely likely
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Timepoint [7]
446948
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Single survey study - will be assessed immediately after the intervention
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Secondary outcome [8]
446954
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Trustworthiness of recommendation
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Assessment method [8]
446954
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11-point NRS ranging from 0=not at all trustworthy to 10=very trustworthy
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Timepoint [8]
446954
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Single survey study - will be assessed immediately after the intervention
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Secondary outcome [9]
446951
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Overall satisfaction
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Assessment method [9]
446951
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11-point NRS ranging from 0=definitely not satisfied to 10=definitely satisfied
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Timepoint [9]
446951
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Single survey study - will be assessed immediately after the intervention
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Eligibility
Key inclusion criteria
Participants will be eligible for the study if they meet the following inclusion criteria:
i) Adults aged 45 years or over;
ii) Currently living in Australia;
iii) Either have, and have not, experienced activity-related knee joint pain in the last 3 months;
iv) Are skeptical about the benefits of exercise for knee OA; and
v) Have never consulted a healthcare professional for chronic knee pain.
Note: We will recruit a sample of 50% who have knee pain, and 50% who do not have knee pain.
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Minimum age
45
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Inability to understand or read English
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After completing baseline measures, participants will be automatically randomised to one of the three groups by the Qualtrics software (using the “randomiser” feature set to evenly present elements at a 1:1:1 ratio).
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This will be done by the Qualtrics software, using the “randomiser” feature set to evenly present elements at a 1:1:1 ratio. The order of group allocation is performed automatically by Qualtrics and is not known to researchers.
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
258
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council (NHMRC) Grant
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Address [1]
318839
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Melbourne
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
321286
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Country [1]
321286
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317456
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University of Melbourne Central Human Research Ethics Committee
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Ethics committee address [1]
317456
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https://research.unimelb.edu.au/work-with-us/ethics-and-integrity/our-ethics-committees
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Ethics committee country [1]
317456
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Australia
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Date submitted for ethics approval [1]
317456
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06/05/2025
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Approval date [1]
317456
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05/06/2025
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Ethics approval number [1]
317456
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Summary
Brief summary
Unfortunately, many people will experience knee osteoarthritis at some point in their life. This can be diagnosed by a health professional. People often have beliefs about treatments for, and the prognosis of, their knee osteoarthritis. Currently, we do not know whether the advice someone receives makes any difference to their beliefs about osteoarthritis treatment or prognosis. This study is interested in learning more about this, and whether different ways of providing advice about knee osteoarthritis impacts people’s beliefs about the condition.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Belinda Lawford
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Address
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161 Barry St, The University of Melbourne, Carlton VIC 3010
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Country
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Australia
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Phone
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+61 03 8344 2045
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Fax
141090
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Email
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[email protected]
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Contact person for public queries
Name
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Belinda Lawford
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Address
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161 Barry St, The University of Melbourne, Carlton VIC 3010
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Country
141091
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Australia
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Phone
141091
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+61 03 8344 2045
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Fax
141091
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Email
141091
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[email protected]
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Contact person for scientific queries
Name
141092
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Belinda Lawford
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Address
141092
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161 Barry St, The University of Melbourne, Carlton VIC 3010
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Country
141092
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Australia
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Phone
141092
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+61 03 8344 2045
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Fax
141092
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Email
141092
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Anyone
Conditions for requesting access:
•
No requirements
What individual participant data might be shared?
•
All de-identified individual participant data
What types of analyses could be done with individual participant data?
•
Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of:
15
years
Where can requests to access individual participant data be made, or data be obtained directly?
•
By contacting Dr Belinda Lawford (
[email protected]
)
Are there extra considerations when requesting access to individual participant data?
No
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.
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