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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
Date last updated
28/04/2021

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
The aim of this study is to evaluate the effect of educational information, with and without a general practitioner recommendation to exercise, on willingness to undertake exercise/physical activity for knee osteoarthritis. Eligible participants will be aged 45+ years and will not currently have osteoarthritis, knee pain, or any condition that makes them unable to exercise. Participants will be asked to complete an online survey, during which they will be randomised to one of three groups and shown different types of educational information to read. Outcome measures will be collected as part of the survey before and after participants read the educational information presented to them.
Trial website
https://clinicaltrials.gov/study/NCT04698655
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04698655