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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05156216
Registration number
NCT05156216
Ethics application status
Date submitted
10/11/2021
Date registered
14/12/2021
Titles & IDs
Public title
Comparative Effect of Two Educational Videos for People With Knee Osteoarthritis (vidEO)
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Scientific title
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
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Secondary ID [1]
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U1111-1269-6143
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Secondary ID [2]
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CT21063
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Universal Trial Number (UTN)
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Trial acronym
vidEO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis
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Patient Empowerment
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Patient education
Experimental: Experimental video - Knee OA educational video based on an empowerment discourse delivered online and embedded within the survey.
Active comparator: Control video - Knee OA educational video based on a disease and impairment discourse delivered online and embedded within the survey.
Other interventions: Patient education
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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Self-efficacy for managing pain from osteoarthritis
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Assessment method [1]
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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.
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Timepoint [1]
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Immediately post intervention
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Primary outcome [2]
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Kinesiophobia
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Assessment method [2]
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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.
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Timepoint [2]
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Immediately post intervention
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Secondary outcome [1]
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Expectations about their knee OA prognosis and benefit from physical activity
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Assessment method [1]
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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.
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Timepoint [1]
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Immediately post intervention
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Secondary outcome [2]
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Importance of physical activity
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Assessment method [2]
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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.
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Timepoint [2]
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Immediately post intervention
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Secondary outcome [3]
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Knee OA knowledge
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Assessment method [3]
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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.
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Timepoint [3]
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Immediately post intervention
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Secondary outcome [4]
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Perceived change in feelings about having knee OA
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Assessment method [4]
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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'.
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Timepoint [4]
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Immediately post intervention
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Secondary outcome [5]
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Perceived personal likelihood of ever needing knee surgery
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Assessment method [5]
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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.
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Timepoint [5]
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Immediately post intervention
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Secondary outcome [6]
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Motivation to be physically active
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Assessment method [6]
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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.
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Timepoint [6]
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Immediately post intervention
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Eligibility
Key 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.
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Minimum age
45
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/02/2022
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Sample size
Target
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Accrual to date
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Final
589
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The University of Melbourne - Melbourne
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Recruitment postcode(s) [1]
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3010 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05156216
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Thorlene Egerton, PhD
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Address
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University of Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05156216