Influence of Osteoarthritis Information on Treatment Beliefs

Osteoarthritis, Knee Clinical Trial

Official title:

Influence of Osteoarthritis eDucational Information and General Practitioner Endorsement on ExerCISe IntentiONs, Beliefs and Willingness to Exercise: the DECISION Randomised Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04698655
• Other study ID #: 20744
• Status: Completed
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: April 5, 2021

Study information

• Verified date: April 2021
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 735
• Est. completion date: April 5, 2021
• Est. primary completion date: April 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Information on treatment options
Asked to read two A4 pages of information on treatment options ("osteoarthritis treatment options")
• Recommendation from general practitioner
Receive a hypothetical general practitioner recommendation for exercise
• Information on osteoarthritis
Asked to read 1 A4 page of brief information on osteoarthritis

Locations

Country	Name	City	State
Australia	The University of Melbourne	Carlton	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
University of Melbourne

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Immediately after reading educational information in survey
Secondary	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)	Immediately after reading educational information in survey
Secondary	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)	Immediately after reading educational information in survey
Secondary	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)	Immediately after reading educational information in survey