Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001145796p
Ethics application status
Submitted, not yet approved
Date submitted
16/08/2022
Date registered
22/08/2022
Date last updated
22/08/2022
Date data sharing statement initially provided
22/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of diagnostic labels and explanations on beliefs about hip pain and its management: A randomised online trial
Scientific title
Effects of diagnostic labels and explanations on beliefs about hip pain and its management in people aged over 45 years with and without hip pain: A randomised online trial
Secondary ID [1] 307621 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip pain 327101 0
Condition category
Condition code
Musculoskeletal 324249 324249 0 0
Osteoarthritis
Musculoskeletal 324250 324250 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be asked to read a scenario explaining a hypothetical hip pain problem. Participants will then be randomised to one of three diagnostic labels and an explanation about it: 1) hip osteoarthritis, 2) persistent hip pain, and 3) hip degeneration.

Hip osteoarthritis and chronic hip pain are the two intervention groups. Hip degeneration is the control group.

The diagnostic labels and explanations were developed by drawing on clinical guidelines, evidence-based definitions of pain and hip osteoarthritis, and qualitative literature of the lived experiences of people with hip pain.

We developed the hip osteoarthritis diagnostic label and explanation by drawing on recommended modern definitions of osteoarthritis. The persistent hip pain study arm is a non-specific diagnostic label incorporating a biopsychosocial explanation of pain.

Participants in all groups will be asked to tick a box to confirm that they had read their assigned diagnostic label and its explanation. This intervention will be delivered once, as a single online survey.

Participants will access the survey through an online link, provided to them by the company CINT (a consumer panel company). The survey will take approximately 15 minutes to complete - with approximately 5 minutes of reading time of the clinical scenario, diagnoses, and explanations, and aproximately 10 minutes to complete pre and post-intervention outcome measures.

The treatment groups will differ in the way they are explained. For example:
1) hip osteoarthritis will use a modern definition of hip osteoarthritis, describing how osteoarthritis may start, potential contributing causes, and the role of joint repair in the disease process
2) persistent hip pain draws on contemporary evidence and definitions of pain, describing potential biopsychosocial contributors to pain, such as fear and emotions.
3) hip degeneration attributes hip pain to things such as age and wear and tear.
Intervention code [1] 324069 0
Treatment: Other
Comparator / control treatment
The hip degeneration study arm includes a pathoanatomic explanation of hip pain. This study group is our control.
Control group
Active

Outcomes
Primary outcome [1] 332097 0
Belief about the harmfulness of exercise
Baseline
How much do you think exercise and physical activity would damage your hypothetical hip problem?

Post intervention
Based on what your general practitioner has told you, how much do you think exercise and physical activity would damage your hypothetical hip problem?
Timepoint [1] 332097 0
Immediately before and after the intervention (as part of the same online survey)
Primary outcome [2] 332098 0
Belief about surgery
Baseline
How necessary do you think surgery would be for your hypothetical hip problem at some stage?

Post Intervention
Based on what your general practitioner has told you, how necessary do you think surgery would be for your hypothetical hip problem at some stage?
Timepoint [2] 332098 0
Immediately before and after the intervention (as part of the same online survey)
Secondary outcome [1] 412197 0
Belief about exercise and physical activity
Baseline:
How much do you think exercise and physical activity would help relieve your hypothetical hip problem?

Post intervention:
Based on what your general practitioner has told you, how much do you think exercise and physical activity would help relieve your hypothetical hip problem?
Timepoint [1] 412197 0
Immediately before and after the intervention (as part of the same online survey)
Secondary outcome [2] 412198 0
Belief about medication
Baseline
How much do you think medication would help your hypothetical hip problem?

Post intervention
Based on what your general practitioner has told you, how much do you think medication would help your hypothetical hip problem?
Timepoint [2] 412198 0
Immediately before and after the intervention (as part of the same online survey)
Secondary outcome [3] 412199 0
Belief about injection
Baseline:
How much do you think an injection would help your hypothetical hip problem?

Post Intervention
Based on what your general practitioner has told you, how much do you think an injection would help your hypothetical hip problem?
Timepoint [3] 412199 0
Immediately before and after the intervention (as part of the same online survey)
Secondary outcome [4] 412200 0
Belief about general practice care
Baseline
How much do you think a general practitioner could help you with your hypothetical hip problem?

Post Intervention
Based on what your general practitioner has told you, how much do you think a general practitioner could help you with your hypothetical hip problem?
Timepoint [4] 412200 0
Immediately before and after the intervention (as part of the same online survey)
Secondary outcome [5] 412201 0
Belief about Sport and Exercise Physician care
How much do you think a sport and exercise physician could help you with your hypothetical hip problem?

Post Intervention
Based on what your general practitioner has told you how much do you think a sport and exercise physician could help you with your hypothetical hip problem?
Timepoint [5] 412201 0
Immediately before and after the intervention (as part of the same online survey)
Secondary outcome [6] 412202 0
Belief about orthopaedic surgeon care
Baseline
How much do you think an orthopaedic surgeon could help you with your hypothetical hip problem?

Post Intervention
Based on what your general practitioner has told you, how much do you think an orthopaedic surgeon could help you with your hip problem?
Timepoint [6] 412202 0
Immediately before and after the intervention (as part of the same online survey)
Secondary outcome [7] 412203 0
Belief about rheumatology care
Baseline
How much do you think a rheumatologist could help you with your hypothetical hip problem?

Post Intervention
Based on what your general practitioner has told you, how much do you think a rheumatologist could help you with your hypothetical hip problem?
Timepoint [7] 412203 0
Immediately before and after the intervention (as part of the same online survey)
Secondary outcome [8] 412204 0
Belief about physiotherapy care
Baseline
How much do you think a physiotherapist could help you with your hypothetical hip problem?

Post Intervention
Based on what your general practitioner has told you, how much do you think a physiotherapist could help you with your hypothetical hip problem?
Timepoint [8] 412204 0
Immediately before and after the intervention (as part of the same online survey)
Secondary outcome [9] 412205 0
Concern about hip pain
Baseline
How concerned are you about your hypothetical hip problem?

Post intervention:
Based on what your general practitioner has told you, how concerned are you about your hypothetical hip problem?
Timepoint [9] 412205 0
Immediately before and after the intervention (as part of the same online survey)
Secondary outcome [10] 412206 0
Satisfaction with information about diagnosis
Post Intervention
Based on what your general practitioner has told you, how satisfied are you with the diagnosis and explanation that the general practitioner provided for your hypothetical hip problem?
Timepoint [10] 412206 0
Immediately after the intervention (as part of the same online survey)

Eligibility
Key inclusion criteria
i) Aged 45 years or over;
ii) Have, or have not, experienced any activity-related hip joint pain in the past 3 months;
iii) Currently living in Australia;
iv) are able to easily understand written English;
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have had a joint replacement in any of their hip joints.

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)
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 ratio). The order of group allocation is performed automatically by Qualtrics and is not known to researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use stratified randomisation to ensure equal distribution of people who have and have not had hip pain across the three study arms.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
1/09/2022
Actual
Date of last participant enrolment
Anticipated
5/09/2022
Actual
Date of last data collection
Anticipated
5/09/2022
Actual
Sample size
Target
636
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311885 0
Government body
Name [1] 311885 0
National Health and Medical Research Council
Country [1] 311885 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne
Parkville, VIC 3010
Australia
Country
Australia
Secondary sponsor category [1] 313392 0
None
Name [1] 313392 0
Address [1] 313392 0
Country [1] 313392 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311320 0
Science, Technology, Engineering, Mathematics and Medicine (STEMM 1)- Greater Than Low Risk (GTLR)
Ethics committee address [1] 311320 0
Ethics committee country [1] 311320 0
Australia
Date submitted for ethics approval [1] 311320 0
12/08/2022
Approval date [1] 311320 0
Ethics approval number [1] 311320 0

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

Contacts
Principal investigator
Name 120702 0
Prof Rana Hinman
Address 120702 0
Level 7, Alan Gilbert Building Building 104, 161 Barry Street
The University of Melbourne
Parkville
Victoria 3010
Australia
Country 120702 0
Australia
Phone 120702 0
+61 03 8344 3223
Fax 120702 0
Email 120702 0
[email protected]
Contact person for public queries
Name 120703 0
Travis Haber
Address 120703 0
Level 7, Alan Gilbert Building Building 104, 161 Barry Street
The University of Melbourne
Parkville
Victoria 3010
Australia
Country 120703 0
Australia
Phone 120703 0
+61431265347
Fax 120703 0
Email 120703 0
[email protected]
Contact person for scientific queries
Name 120704 0
Rana Hinman
Address 120704 0
Level 7, Alan Gilbert Building Building 104, 161 Barry Street
The University of Melbourne
Parkville
Victoria 3010
Australia
Country 120704 0
Australia
Phone 120704 0
+61 03 8344 3223
Fax 120704 0
Email 120704 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data relating to primary and secondary outcomes
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Individual researchers with reasonable request for the data
Available for what types of analyses?
Any purpose
How or where can data be obtained?
By contacting the primary investigator ([email protected])


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.