Influence of Osteoarthritis Information on Treatment Beliefs

NCT ID: NCT04698655

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

735 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-24

Study Completion Date

2021-04-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

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

Group Type ACTIVE_COMPARATOR

Information on osteoarthritis

Intervention Type OTHER

Asked to read 1 A4 page of brief information on osteoarthritis

Treatment options group

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

Group Type EXPERIMENTAL

Information on treatment options

Intervention Type OTHER

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

Information on osteoarthritis

Intervention Type OTHER

Asked to read 1 A4 page of brief information on osteoarthritis

Treatment options + recommendation group

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

Group Type EXPERIMENTAL

Information on treatment options

Intervention Type OTHER

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

Recommendation from general practitioner

Intervention Type OTHER

Receive a hypothetical general practitioner recommendation for exercise

Information on osteoarthritis

Intervention Type OTHER

Asked to read 1 A4 page of brief information on osteoarthritis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Information on treatment options

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

Intervention Type OTHER

Recommendation from general practitioner

Receive a hypothetical general practitioner recommendation for exercise

Intervention Type OTHER

Information on osteoarthritis

Asked to read 1 A4 page of brief information on osteoarthritis

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Melbourne

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Belinda Lawford

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Belinda J Lawford

Role: PRINCIPAL_INVESTIGATOR

University of Melbourne

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Melbourne

Carlton, Victoria, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20744

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Wearable Sensors in Knee OA
NCT04243096 COMPLETED NA