Influence of Osteoarthritis Information on Treatment Beliefs
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Information on treatment options
Recommendation from general practitioner
Information on osteoarthritis
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Education, Decision aid, Beliefs
Eligibility Criteria
Inclusion Criteria:
- Aged 45+ years
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
Sites / Locations
- The University of Melbourne
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control group
Treatment options group
Treatment options + recommendation group
Arm Description
Asked to read a single-A4 page of brief osteoarthritis information ("what is osteoarthritis")
Asked to read brief osteoarthritis information + two A4 pages of information on treatment options ("osteoarthritis treatment options")
Asked to read brief osteoarthritis information + information on treatment options + receive hypothetical general practitioner recommendation for exercise
Outcomes
Primary Outcome Measures
Belief that an exercise or physical activity program is the most appropriate management option for their knee
Measured on an 11-point scale (0 = strongly disagree 10 = strongly agree)
Secondary Outcome Measures
Belief surgery, weight loss, x-rays, injections and medications are the most appropriate management options for their knee
Measured on an 11-point scale (0 = strongly disagree 10 = strongly agree)
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
Measured on an 11-point scale (0 = definitely would not 10 = definitely would)
Belief about the effectiveness of surgery, weight loss, x-rays, injections and medications for people with knee osteoarthritis
Measured on an 11-point scale (0 = strongly disagree 10 = strongly agree)
Full Information
NCT ID
NCT04698655
First Posted
December 13, 2020
Last Updated
April 26, 2021
Sponsor
University of Melbourne
1. Study Identification
Unique Protocol Identification Number
NCT04698655
Brief Title
Influence of Osteoarthritis Information on Treatment Beliefs
Official Title
Influence of Osteoarthritis eDucational Information and General Practitioner Endorsement on ExerCISe IntentiONs, Beliefs and Willingness to Exercise: the DECISION Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
April 5, 2021 (Actual)
Study Completion Date
April 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Melbourne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
3-arm superiority online randomised controlled trial (delivered within one survey). Participants will complete an online survey, during which they will be presented with a hypothetical scenario asking them to imagine that they had recently developed knee pain and have gone to see their general practitioner. Participants will then be randomised to one of 3 different groups (described below). Each group will be shown different types of educational material and asked to read the information carefully. Once they have finished reading the material, they will be asked to complete follow-up outcome measures to determine whether their beliefs about osteoarthritis management strategies have changed.
The 3 trial groups are:
I. Control group: asked to read a single-A4 page of brief osteoarthritis information ("what is osteoarthritis"); II. Treatment options group: asked to read brief osteoarthritis information + two A4 pages of information on treatment options ("osteoarthritis treatment options"), and; III. Treatment options + recommendation group: asked to read brief osteoarthritis information + information on treatment options + receive a hypothetical GP recommendation for exercise
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Knee, Education, Decision aid, Beliefs
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
735 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Asked to read a single-A4 page of brief osteoarthritis information ("what is osteoarthritis")
Arm Title
Treatment options group
Arm Type
Experimental
Arm Description
Asked to read brief osteoarthritis information + two A4 pages of information on treatment options ("osteoarthritis treatment options")
Arm Title
Treatment options + recommendation group
Arm Type
Experimental
Arm Description
Asked to read brief osteoarthritis information + information on treatment options + receive hypothetical general practitioner recommendation for exercise
Intervention Type
Other
Intervention Name(s)
Information on treatment options
Intervention Description
Asked to read two A4 pages of information on treatment options ("osteoarthritis treatment options")
Intervention Type
Other
Intervention Name(s)
Recommendation from general practitioner
Intervention Description
Receive a hypothetical general practitioner recommendation for exercise
Intervention Type
Other
Intervention Name(s)
Information on osteoarthritis
Intervention Description
Asked to read 1 A4 page of brief information on osteoarthritis
Primary Outcome Measure Information:
Title
Belief that an exercise or physical activity program is the most appropriate management option for their knee
Description
Measured on an 11-point scale (0 = strongly disagree 10 = strongly agree)
Time Frame
Immediately after reading educational information in survey
Secondary Outcome Measure Information:
Title
Belief surgery, weight loss, x-rays, injections and medications are the most appropriate management options for their knee
Description
Measured on an 11-point scale (0 = strongly disagree 10 = strongly agree)
Time Frame
Immediately after reading educational information in survey
Title
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
Description
Measured on an 11-point scale (0 = definitely would not 10 = definitely would)
Time Frame
Immediately after reading educational information in survey
Title
Belief about the effectiveness of surgery, weight loss, x-rays, injections and medications for people with knee osteoarthritis
Description
Measured on an 11-point scale (0 = strongly disagree 10 = strongly agree)
Time Frame
Immediately after reading educational information in survey
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 45+ years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belinda J Lawford
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Melbourne
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3101
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
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Influence of Osteoarthritis Information on Treatment Beliefs
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