NCT04698655

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
735

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

March 24, 2021

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

12 days

First QC Date

December 13, 2020

Last Update Submit

April 26, 2021

Conditions

Keywords

OsteoarthritisKneeEducationDecision aidBeliefs

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (3)

Control group

ACTIVE COMPARATOR

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

Other: Information on osteoarthritis

Treatment options group

EXPERIMENTAL

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

Other: Information on treatment optionsOther: Information on osteoarthritis

Treatment options + recommendation group

EXPERIMENTAL

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

Other: Information on treatment optionsOther: Recommendation from general practitionerOther: Information on osteoarthritis

Interventions

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

Treatment options + recommendation groupTreatment options group

Receive a hypothetical general practitioner recommendation for exercise

Treatment options + recommendation group

Asked to read 1 A4 page of brief information on osteoarthritis

Control groupTreatment options + recommendation groupTreatment options group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 45+ years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Melbourne

Carlton, Victoria, 3101, Australia

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Belinda J Lawford

    University of Melbourne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2020

First Posted

January 7, 2021

Study Start

March 24, 2021

Primary Completion

April 5, 2021

Study Completion

April 5, 2021

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations