Clinical trial NCT04698655: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Knee
Education
Decision aid
Beliefs
Lead sponsor: University of Melbourne
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 735
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Belief that an exercise or physical activity program is the most appropriate management option for their knee
timeFrame: Immediately after reading educational information in survey
Secondary outcomes:
measure: Belief surgery, weight loss, x-rays, injections and medications are the most appropriate management options for their knee
timeFrame: Immediately after reading educational information in survey
measure: 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
timeFrame: Immediately after reading educational information in survey
measure: Belief about the effectiveness of surgery, weight loss, x-rays, injections and medications for people with knee osteoarthritis
timeFrame: Immediately after reading educational information in survey
Other outcomes:
Locations:
city: Carlton
country: Australia
facility: The University of Melbourne
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Belinda J Lawford
role: PRINCIPAL_INVESTIGATOR
References: