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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04698655




Registration number
NCT04698655
Ethics application status
Date submitted
13/12/2020
Date registered
7/01/2021

Titles & IDs
Public title
Influence of Osteoarthritis Information on Treatment Beliefs
Scientific title
Influence of Osteoarthritis eDucational Information and General Practitioner Endorsement on ExerCISe IntentiONs, Beliefs and Willingness to Exercise: the DECISION Randomised Controlled Trial.
Secondary ID [1] 0 0
20744
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Information on treatment options
Other interventions - Recommendation from general practitioner
Other interventions - Information on osteoarthritis

Active comparator: Control group - Asked to read a single-A4 page of brief osteoarthritis information ("what is osteoarthritis")

Experimental: Treatment options group - Asked to read brief osteoarthritis information + two A4 pages of information on treatment options ("osteoarthritis treatment options")

Experimental: Treatment options + recommendation group - Asked to read brief osteoarthritis information + information on treatment options + receive hypothetical general practitioner recommendation for exercise


Other interventions: Information on treatment options
Asked to read two A4 pages of information on treatment options ("osteoarthritis treatment options")

Other interventions: Recommendation from general practitioner
Receive a hypothetical general practitioner recommendation for exercise

Other interventions: Information on osteoarthritis
Asked to read 1 A4 page of brief information on osteoarthritis
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Belief that an exercise or physical activity program is the most appropriate management option for their knee
Timepoint [1] 0 0
Immediately after reading educational information in survey
Secondary outcome [1] 0 0
Belief surgery, weight loss, x-rays, injections and medications are the most appropriate management options for their knee
Timepoint [1] 0 0
Immediately after reading educational information in survey
Secondary outcome [2] 0 0
Intentions to request a referral to an orthopedic surgeon, physiotherapist, and dietitian or to request prescription for medications, an injection, and an x-ray for their knee
Timepoint [2] 0 0
Immediately after reading educational information in survey
Secondary outcome [3] 0 0
Belief about the effectiveness of surgery, weight loss, x-rays, injections and medications for people with knee osteoarthritis
Timepoint [3] 0 0
Immediately after reading educational information in survey

Eligibility
Key inclusion criteria
* Aged 45+ years
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Been told by a health professional that they have osteoarthritis in any joint/anywhere in the body
* Have experienced any knee pain in the prior 3 months
* Unable to read English
* Have had a joint replacement in any knee or hip joint
* Have any health condition that makes unable to exercise

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/04/2021
Sample size
Target
Accrual to date
Final
735
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The University of Melbourne - Carlton
Recruitment postcode(s) [1] 0 0
3101 - Carlton

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Belinda J Lawford
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04698655