NCT05156216

Brief Summary

Education is an important part of knee osteoarthritis management. The aim of education is to help people with knee osteoarthritis make the best choices for them in terms of their treatment and lifestyle behaviours. Traditional education that describes the condition simplistically in terms of the joint damage and describes the cause of osteoarthritis solely with respect to loading through the joint can lead to activity avoidance and pessimism about the future progression of symptoms. An alternative is to provide the information about knee osteoarthritis management with the aim of giving hope for the future and building motivation and confidence to be physically active. This study will compare two educational videos that cover the same topics but with a contrasting 'discourse'. The experimental video has an 'empowerment and participatory' discourse, while the comparator or control video has a typical 'disease and impairment' discourse. The experimental video minimises mention of joint damage and instead corrects misconceptions about knee osteoarthritis, addresses common barriers to physical activity and incorporates behaviour change techniques such as social learning and modelling of desired behaviours. In this randomised controlled trial, people who report a history of knee problems consistent with knee osteoarthritis will complete questionnaires to determine their self-efficacy for managing knee osteoarthritis pain and their fear of movement. The participants will also be asked about their expectations for the future, their level of motivation to be physically active, and their knowledge about knee osteoarthritis. Participants will then be allocated one of the videos and asked to watch it before repeating the questionnaires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
589

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable knee-osteoarthritis

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2021

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 14, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

23 days

First QC Date

November 10, 2021

Last Update Submit

May 16, 2022

Conditions

Keywords

knee osteoarthritispatient educationhealth informationempowerment discoursevideorandomised controlled trial

Outcome Measures

Primary Outcomes (2)

  • Self-efficacy for managing pain from osteoarthritis

    Self-efficacy is considered fundamental for effective chronic disease self-management and greater self-efficacy is related to higher physical activity levels in people with OA. Self-efficacy will be measured with the Arthritis Self-Efficacy Scale (ASES) (pain subscale). Range 0-10, higher scores mean better self-efficacy.

    Immediately post intervention

  • Kinesiophobia

    Kinesiophobia is the fear that movement will exacerbate pain. According to the fear-avoidance model, fear is worsened by heightened negative emotion and hypervigilance to symptoms. Kinesiophobia will be measured with the Brief Fear of Movement Scale for Osteoarthritis (BFMS). Range 6-24, lower scores mean better outcome.

    Immediately post intervention

Secondary Outcomes (6)

  • Expectations about their knee OA prognosis and benefit from physical activity

    Immediately post intervention

  • Importance of physical activity

    Immediately post intervention

  • Knee OA knowledge

    Immediately post intervention

  • Perceived change in feelings about having knee OA

    Immediately post intervention

  • Perceived personal likelihood of ever needing knee surgery

    Immediately post intervention

  • +1 more secondary outcomes

Other Outcomes (3)

  • Novelty check

    Immediately post intervention

  • Fidelity check

    Immediately post intervention

  • Satisfaction with the video education

    Immediately post intervention

Study Arms (2)

Experimental video

EXPERIMENTAL

Knee OA educational video based on an empowerment discourse delivered online and embedded within the survey.

Other: Patient education

Control video

ACTIVE COMPARATOR

Knee OA educational video based on a disease and impairment discourse delivered online and embedded within the survey.

Other: Patient education

Interventions

Knowledge and beliefs about the condition and its management influences patient behavioural intentions, including treatment choices. Thus, patient education may play an important role in facilitating desirable behaviours with the aim of education being to develop accurate beliefs about treatment options and empower people to choose wisely for their current needs and circumstances.

Also known as: Health information
Control videoExperimental video

Eligibility Criteria

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

You may qualify if:

  • live in Australia;
  • are aged 45 years or over;
  • have experienced activity-related knee pain during the past 3 months or have been told by a health professional that they have knee OA, ; and
  • are able to easily understand verbal and written English language.

You may not qualify if:

  • have had a hip or knee joint replacement;
  • are scheduled/referred to see an orthopaedic surgeon or are already on a waiting list for hip or knee joint replacement;
  • have any type of systemic arthritis (e.g. rheumatoid arthritis, gout), or have morning stiffness that lasts longer than 30 minutes;
  • have a health condition that makes them unable to walk (since it will be difficult for people who cannot walk to follow the recommendations made in either video);
  • have seen a health professional for their knee pain during the previous six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Melbourne

Melbourne, Victoria, 3010, Australia

Location

Related Publications (1)

  • Egerton T, Bennell KL, McManus F, Lamb KE, Hinman RS. Comparative effect of two educational videos on self-efficacy and kinesiophobia in people with knee osteoarthritis: an online randomised controlled trial. Osteoarthritis Cartilage. 2022 Oct;30(10):1398-1410. doi: 10.1016/j.joca.2022.05.010. Epub 2022 Jun 22.

MeSH Terms

Conditions

Osteoarthritis, KneePatient Participation

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Thorlene Egerton, PhD

    University of Melbourne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Limited disclosure will be used to blind participants and thereby reduce bias in responses since participants are also the assessors as all outcome measurements are self-reported. Participants will simply be informed that the trial aim is to assess knee OA educational videos. The investigators will not disclose details about how the educational content/presentation of the two videos differ, nor the hypotheses of the study. The biostatistician who performs the data analysis will be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomised to one of two groups (1:1) using the randomiser function in Qualtrics (set to 'evenly present elements').
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2021

First Posted

December 14, 2021

Study Start

November 1, 2021

Primary Completion

November 24, 2021

Study Completion

February 15, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations