Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000551493p
Ethics application status
Submitted, not yet approved
Date submitted
14/05/2025
Date registered
30/05/2025
Date last updated
30/05/2025
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.
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.
Secondary ID [1] 314317 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 337269 0
Condition category
Condition code
Musculoskeletal 333669 333669 0 0
Osteoarthritis
Public Health 333937 333937 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 330926 0
Treatment: Other
Intervention code [2] 331142 0
Behaviour
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).
Control group
Active

Outcomes
Primary outcome [1] 341261 0
Belief about exercise and physical activity (composite outcome)
Timepoint [1] 341261 0
Single survey study - will be assessed immediately after the intervention
Secondary outcome [1] 446947 0
Belief about safety of exercise and physical activity (composite outcome)
Timepoint [1] 446947 0
Single survey study - will be assessed immediately after the intervention
Secondary outcome [2] 446948 0
Intentions to start exercising
Timepoint [2] 446948 0
Single survey study - will be assessed immediately after the intervention
Secondary outcome [3] 446949 0
Belief about joint replacement surgery
Timepoint [3] 446949 0
Single survey study - will be assessed immediately after the intervention
Secondary outcome [4] 446950 0
Belief about medication
Timepoint [4] 446950 0
Single survey study - will be assessed immediately after the intervention
Secondary outcome [5] 446951 0
Overall satisfaction
Timepoint [5] 446951 0
Single survey study - will be assessed immediately after the intervention
Secondary outcome [6] 446952 0
Confidence
Timepoint [6] 446952 0
Single survey study - will be assessed immediately after the intervention
Secondary outcome [7] 446953 0
Likelihood to seek a second opinion
Timepoint [7] 446953 0
Single survey study - will be assessed immediately after the intervention
Secondary outcome [8] 446954 0
Trustworthiness of recommendation
Timepoint [8] 446954 0
Single survey study - will be assessed immediately after the intervention
Secondary outcome [9] 446955 0
Trustworthiness of healthcare professional
Timepoint [9] 446955 0
Single survey study - will be assessed immediately after the intervention

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.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to understand or read English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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).
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.
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
258
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318839 0
Government body
Name [1] 318839 0
National Health and Medical Research Council (NHMRC) Grant
Country [1] 318839 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 321286 0
None
Name [1] 321286 0
Address [1] 321286 0
Country [1] 321286 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317456 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 317456 0
Ethics committee country [1] 317456 0
Australia
Date submitted for ethics approval [1] 317456 0
06/05/2025
Approval date [1] 317456 0
Ethics approval number [1] 317456 0

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

Contacts
Principal investigator
Name 141090 0
Dr Belinda Lawford
Address 141090 0
161 Barry St, The University of Melbourne, Carlton VIC 3010
Country 141090 0
Australia
Phone 141090 0
+61 03 8344 2045
Fax 141090 0
Email 141090 0
[email protected]
Contact person for public queries
Name 141091 0
Belinda Lawford
Address 141091 0
161 Barry St, The University of Melbourne, Carlton VIC 3010
Country 141091 0
Australia
Phone 141091 0
+61 03 8344 2045
Fax 141091 0
Email 141091 0
[email protected]
Contact person for scientific queries
Name 141092 0
Belinda Lawford
Address 141092 0
161 Barry St, The University of Melbourne, Carlton VIC 3010
Country 141092 0
Australia
Phone 141092 0
+61 03 8344 2045
Fax 141092 0
Email 141092 0
[email protected]

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.