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Trial registered on ANZCTR


Registration number
ACTRN12622000630718
Ethics application status
Approved
Date submitted
22/04/2022
Date registered
28/04/2022
Date last updated
24/03/2024
Date data sharing statement initially provided
28/04/2022
Date results information initially provided
21/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing effects of knee osteoarthritis educational information, with and without pathoanatomical content, on consumer osteoarthritis management beliefs: An online randomised controlled trial.
Scientific title
Comparing effects of knee osteoarthritis educational information, with and without pathoanatomical content, on consumer osteoarthritis management beliefs: An online randomised controlled trial.
Secondary ID [1] 306986 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 326101 0
Condition category
Condition code
Musculoskeletal 323415 323415 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the Experimental group will be asked to read an approx. 1-page digital information pamphlet about osteoarthritis that was created by the research team based on the content that is currently provided on international osteoarthritis consumer organisation websites. The content will be a similar to that contained in the Control group, but all pathoanatomical information and terminology will be removed.

To develop this information sheet, the researchers reviewed the Control group information pamphlet and deleted any words and/or sentences that related to joint anatomy or pathology, including words that described the joint structure, and words related to pathology like ‘damage’ and ‘wear and tear’. A diagram that depicted an image of a healthy joint compared to a joint affected by osteoarthritis was also removed. No new words, sentences or images were added to replace those that were removed.

Participants in both groups will be asked to tick a box to confirm that they had read the information sheet and estimate how long they had spent reading it. The survey software (Qualtrics) will also measure how long each respondent spends on the page that has the information sheet.
Intervention code [1] 323428 0
Treatment: Other
Comparator / control treatment
Participants will be asked to read an approx. 1-page digital information pamphlet about osteoarthritis that was created by the research team based on the content that is currently provided on international osteoarthritis consumer organisation websites.
Control group
Active

Outcomes
Primary outcome [1] 331154 0
If you were told by your doctor that you had knee osteoarthritis, would you think an x-ray is necessary to confirm the diagnosis?

11-point Numeric Rating Scale (NRS) ranging from 0=definitely unnecessary to 10=definitely necessary
Timepoint [1] 331154 0
Immediately before and after the intervention (as part of the same online survey)
Primary outcome [2] 331155 0
If you were told by your doctor that you had knee osteoarthritis, would you think joint replacement surgery (to replace the affected joint with an artificial joint) is necessary for your knee at some stage?

11-point NRS ranging from 0=definitely unnecessary to 10=definitely necessary
Timepoint [2] 331155 0
Immediately before and after the intervention (as part of the same online survey)
Secondary outcome [1] 409021 0
If you were told by your doctor that you had knee osteoarthritis, would you think exercise and physical activity is helpful to manage it?

11-point NRS ranging from 0=definitely not helpful to 10=definitely helpful
Timepoint [1] 409021 0
Immediately before and after the intervention (as part of the same online survey)
Secondary outcome [2] 409022 0
If you were told by your doctor that you had knee osteoarthritis, would you think exercise and physical activity would damage your knee?

11-point NRS ranging from 0=definitely would not damage it to 10=definitely would damage it
Timepoint [2] 409022 0
Immediately before and after the intervention (as part of the same online survey)
Secondary outcome [3] 409023 0
If you were told by your doctor that you had knee osteoarthritis, would you think medication is helpful to manage your knee symptoms?

11-point NRS ranging from 0=definitely not helpful to 10=definitely helpful
Timepoint [3] 409023 0
Immediately before and after the intervention (as part of the same online survey)
Secondary outcome [4] 409024 0
If you were told by your doctor that you had knee osteoarthritis, would you think an x-ray is necessary to determine the best treatment for your knee?

11-point NRS ranging from 0=definitely unnecessary to 10=definitely necessary
Timepoint [4] 409024 0
Immediately before and after the intervention (as part of the same online survey)
Secondary outcome [5] 409025 0
Knee Osteoarthritis Knowledge Scale (KOAKS)
Timepoint [5] 409025 0
Immediately before and after the intervention (as part of the same online survey)
Secondary outcome [6] 409026 0
If you were told by your doctor that you have knee osteoarthritis, how concerned would you be that your knee problem would get worse in the future?

4-point Likert scale with response options:
Not at all concerned
A little concerned
Quite concerned
Very concerned
Timepoint [6] 409026 0
Immediately before and after the intervention (as part of the same online survey)

Eligibility
Key inclusion criteria
Participants will be eligible for the study if they meet the following inclusion criteria:
i) Aged 45 years or over;
ii) Have, or have not, experienced any activity-related knee joint pain in the past 3 months;
iii) Currently living in Australia.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
i) Inability to understand or read English;
ii) Have had a joint replacement in any of their knee joints .

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)
Randomisation will be performed automatically 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)
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
Completed
Date of first participant enrolment
Anticipated
6/06/2022
Actual
7/06/2022
Date of last participant enrolment
Anticipated
Actual
10/06/2022
Date of last data collection
Anticipated
Actual
10/06/2022
Sample size
Target
556
Accrual to date
Final
556
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311297 0
Government body
Name [1] 311297 0
National Health and Medical Research Council
Country [1] 311297 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Parkville, VIC 3010
Country
Australia
Secondary sponsor category [1] 312662 0
None
Name [1] 312662 0
Address [1] 312662 0
Country [1] 312662 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310800 0
The University of Melbourne Office of Research Ethics and Integrity
Ethics committee address [1] 310800 0
Office of Research Ethics and Integrity | Research, Innovation & Commercialisation
Level 5, Alan Gilbert Building, 161 Barry Street, Carlton
The University of Melbourne, Victoria 3010, Australia
Ethics committee country [1] 310800 0
Australia
Date submitted for ethics approval [1] 310800 0
22/04/2022
Approval date [1] 310800 0
06/06/2022
Ethics approval number [1] 310800 0

Summary
Brief summary
We are conducting a trial to evaluate whether the removal of pathoanatomically-based biological information about knee osteoarthritis from a patient information pamphlet changes consumer management beliefs, compared to a standard information pamphlet that includes pathoanatomical information.

The entire trial will be administered in one single online survey. Participants will initially complete screening questions within the survey to determine eligibility. Eligible participants will then complete baseline outcome measures before being randomly allocated to one of two groups, both of whom will then be asked to immediately read a digital information pamphlet about knee osteoarthritis on screen:
i) Control group: the pamphlet will contain information about osteoarthritis including biological pathoanatomical information and language about osteoarthritis
ii) Experimental group: the same pamphlet as the Control group, but with all pathoanatomical information and language relating to the structure of an osteoarthritis joint removed.

All participants will complete outcome measures again, immediately after reading their allocated digital information pamphlet.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118914 0
Dr Belinda Lawford
Address 118914 0
Centre for Health, Exercise and Sports Medicine | Department of Physiotherapy
Level 7, Alan Gilbert Building,
Building 104, 161 Barry Street
The University of Melbourne, Victoria 3010 Australia
Country 118914 0
Australia
Phone 118914 0
+61424939907
Fax 118914 0
Email 118914 0
belinda.lawford@unimelb.edu.au
Contact person for public queries
Name 118915 0
Dr Belinda Lawford
Address 118915 0
Centre for Health, Exercise and Sports Medicine | Department of Physiotherapy
Level 7, Alan Gilbert Building,
Building 104, 161 Barry Street
The University of Melbourne, Victoria 3010 Australia
Country 118915 0
Australia
Phone 118915 0
+61424939907
Fax 118915 0
Email 118915 0
belinda.lawford@unimelb.edu.au
Contact person for scientific queries
Name 118916 0
Dr Belinda Lawford
Address 118916 0
Centre for Health, Exercise and Sports Medicine | Department of Physiotherapy
Level 7, Alan Gilbert Building,
Building 104, 161 Barry Street
The University of Melbourne, Victoria 3010 Australia
Country 118916 0
Australia
Phone 118916 0
+61424939907
Fax 118916 0
Email 118916 0
belinda.lawford@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data presented in the results paper (JOSPT. DOI: 10.2519/jospt.2022.11618) available in XLSX format.
When will data be available (start and end dates)?
12-12-2022 to 12-12-2037 (a period of 15 years from publication)
Available to whom?
Data will be made available as required for specific, approved analyses by researchers. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.
Available for what types of analyses?
The investigators endorse the concept of data sharing to advance medical science. All requests for data sharing will be reviewed by the Principal Investigator to ensure no conflict with any planned sub analyses and to ensure that the data are shared in an ethical and protected manner.

Analyses aimed to improve treatment of knee osteoarthritis for non-commercial purposes are eligible.
How or where can data be obtained?
By emailing the Principal Investigator at belinda.lawford@unimelb.edu.au. Data will be made available after review and approval by the Principal Investigator. Before any analysis, a signed Confidentiality Agreement and/or Data Sharing Agreement is required.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21959Data dictionary  belinda.lawford@unimelb.edu.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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