Influence of Osteoarthritis Information on Treatment Beliefs

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: Information on osteoarthritis; Other: Information on treatment options; Other: Recommendation from general practitioner

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

• Study Type: Interventional
• Enrollment (Actual): 735
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Carlton, Victoria, Australia, 3101
      • The University of Melbourne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 osteoarthritis; Asked to read 1 A4 page of brief information on osteoarthritis; Other: Information on treatment options; Asked to read 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: Information on osteoarthritis; Asked to read 1 A4 page of brief information on osteoarthritis; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Melbourne
• Investigators: Principal Investigator: Belinda J Lawford, University of Melbourne

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Actual): April 5, 2021
• Study Completion (Actual): April 5, 2021

Study Registration Dates

• First Submitted: December 13, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee; Education; Beliefs; Decision aid
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 20744

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No