Influence of Osteoarthritis Information on Treatment Beliefs

Sponsor

University of Melbourne (Other)

Overall Status

Completed

CT.gov ID

NCT04698655

Collaborator

(none)

735

Enrollment

Location

Arms

Actual Duration (Days)

1864.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Other: Information on treatment options Other: Recommendation from general practitioner Other: Information on osteoarthritis	N/A

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:

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

Study Design

Study Type:

Interventional

Actual Enrollment :

735 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 24, 2021

Actual Primary Completion Date :

Apr 5, 2021

Actual Study Completion Date :

Apr 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group Asked to read a single-A4 page of brief osteoarthritis information ("what is osteoarthritis")	Other: Information on osteoarthritis Asked to read 1 A4 page of brief information on osteoarthritis
Experimental: Treatment options group Asked to read brief osteoarthritis information + two A4 pages of information on treatment options ("osteoarthritis treatment options")	Other: Information on treatment options Asked to read two A4 pages of information on treatment options ("osteoarthritis treatment options") Other: Information on osteoarthritis Asked to read 1 A4 page of brief information on osteoarthritis
Experimental: Treatment options + recommendation group Asked to read brief osteoarthritis information + information on treatment options + receive hypothetical general practitioner recommendation for exercise	Other: Information on treatment options Asked to read two A4 pages of information on treatment options ("osteoarthritis treatment options") Other: Recommendation from general practitioner Receive a hypothetical general practitioner recommendation for exercise Other: Information on osteoarthritis Asked to read 1 A4 page of brief information on osteoarthritis

Arm

Intervention/Treatment

Active Comparator: Control group

Asked to read a single-A4 page of brief osteoarthritis information ("what is osteoarthritis")

Other: Information on osteoarthritis

Asked to read 1 A4 page of brief information on osteoarthritis

Experimental: Treatment options group

Asked to read brief osteoarthritis information + two A4 pages of information on treatment options ("osteoarthritis treatment options")

Other: Information on treatment options

Asked to read two A4 pages of information on treatment options ("osteoarthritis treatment options")

Other: Information on osteoarthritis

Asked to read 1 A4 page of brief information on osteoarthritis

Experimental: Treatment options + recommendation group

Asked to read brief osteoarthritis information + information on treatment options + receive hypothetical general practitioner recommendation for exercise

Other: Information on treatment options

Asked to read two A4 pages of information on treatment options ("osteoarthritis treatment options")

Other: Recommendation from general practitioner

Receive a hypothetical general practitioner recommendation for exercise

Other: Information on osteoarthritis

Asked to read 1 A4 page of brief information on osteoarthritis

Outcome Measures

Primary Outcome Measures

Belief that an exercise or physical activity program is the most appropriate management option for their knee [Immediately after reading educational information in survey]
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 [Immediately after reading educational information in survey]
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 [Immediately after reading educational information in survey]
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 [Immediately after reading educational information in survey]
Measured on an 11-point scale (0 = strongly disagree 10 = strongly agree)

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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