- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05156216
Comparative Effect of Two Educational Videos for People With Knee Osteoarthritis (vidEO) (vidEO)
May 16, 2022 updated by: University of Melbourne
Comparative Effect of Two Educational Videos for People With Knee Osteoarthritis - Disease and Impairment Discourse Versus Empowerment and Participatory Discourse: vidEO - An Online Randomised Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
589
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Victoria
-
Melbourne, Victoria, Australia, 3010
- The University of Melbourne
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental video
Knee OA educational video based on an empowerment discourse delivered online and embedded within the survey.
|
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.
Other Names:
|
|
Active Comparator: Control video
Knee OA educational video based on a disease and impairment discourse delivered online and embedded within the survey.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-efficacy for managing pain from osteoarthritis
Time Frame: Immediately post intervention
|
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
Time Frame: Immediately post intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Expectations about their knee OA prognosis and benefit from physical activity
Time Frame: Immediately post intervention
|
The Credibility/Expectations Questionnaire, which was designed to measure expectation of benefit from therapy, was adapted to measure expectations about their knee OA prognosis and the perceived effect of physical activity.There are two parts, Part 1: range 3-27, higher scores better.
Part 2: range 2-18, higher scores better.
|
Immediately post intervention
|
|
Importance of physical activity
Time Frame: Immediately post intervention
|
Perceived importance of being physically active will be measured through rating the level of agreement with four statements.
Likert scaling with 5 response options.
Responses averaged so scores range 1-5.
Two items reverse scored so that high scores indicate better.
|
Immediately post intervention
|
|
Knee OA knowledge
Time Frame: Immediately post intervention
|
Knowledge and beliefs about knee OA will be measured using the Knee Osteoarthritis Knowledge Scale (KOAKS).
This scale has established content validity and is currently being examined for other psychometric properties.
It currently has 15 items and scores range from 15-75 with higher scores indicated better knowledge, however, some items may be removed once reliability study is published.
|
Immediately post intervention
|
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Perceived change in feelings about having knee OA
Time Frame: Immediately post intervention
|
Post-intervention change in feelings about having knee OA (specifically "How much have your feelings of hope for the future changed since watching the video?"), will be rated using a Likert scale with 5 response options.
Responses will be dichotomised with participants indicating they are "somewhat more" or "much more" classified as 'more hopeful'.
All other respondents classified as 'not more hopeful'.
|
Immediately post intervention
|
|
Perceived personal likelihood of ever needing knee surgery
Time Frame: Immediately post intervention
|
Perceived personal chance of ever having surgery will be measured using 5 level Likert scale from very unlikely to very likely.
Scores range 1-5 with lower scores being considered better.
|
Immediately post intervention
|
|
Motivation to be physically active
Time Frame: Immediately post intervention
|
Motivation to be physically active will be determined by asking participants to rate 'How motivated are you to be physically active (e.g., walk, run, swim, cycle, dance, exercise, etc) even when you are feeling knee pain?', on a scale from 0 (not at all motivated) to 10 (very motivated).
This question is drawn from the Information-Motivation-Behavioural skills model of behaviour change, which explains that having the motivation to change is an essential determinant of behaviour that is independent of both knowledge and behavioural skills.
Range 0-10 with higher scores indicating greater motivation.
|
Immediately post intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Novelty check
Time Frame: Immediately post intervention
|
Have you seen the video before?
Yes/no
|
Immediately post intervention
|
|
Fidelity check
Time Frame: Immediately post intervention
|
How many times did you watch the video before completing this questionnaire? 0 = Did not watch the video or only watched part of the video
|
Immediately post intervention
|
|
Satisfaction with the video education
Time Frame: Immediately post intervention
|
How satisfied are you that the video helped meet your current needs for information about knee osteoarthritis?
Single item Likert scale with 5 response options.
Responses dichotomised to those indicating they are "moderately satisfied" or "very satisfied" classified as satisfied.
|
Immediately post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thorlene Egerton, PhD, University of Melbourne
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2021
Primary Completion (Actual)
November 24, 2021
Study Completion (Actual)
February 15, 2022
Study Registration Dates
First Submitted
November 10, 2021
First Submitted That Met QC Criteria
December 8, 2021
First Posted (Actual)
December 14, 2021
Study Record Updates
Last Update Posted (Actual)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 16, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT21063
- U1111-1269-6143 (Other Identifier: Universal Trial Number - World Health Organization)
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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