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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
Date last updated
18/05/2022

Titles & IDs
Public title
Comparative Effect of Two Educational Videos for People With Knee Osteoarthritis (vidEO)
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
Secondary ID [1] 0 0
U1111-1269-6143
Secondary ID [2] 0 0
CT21063
Universal Trial Number (UTN)
Trial acronym
vidEO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 0 0
Patient Empowerment 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Self-efficacy for managing pain from osteoarthritis
Timepoint [1] 0 0
Immediately post intervention
Primary outcome [2] 0 0
Kinesiophobia
Timepoint [2] 0 0
Immediately post intervention
Secondary outcome [1] 0 0
Expectations about their knee OA prognosis and benefit from physical activity
Timepoint [1] 0 0
Immediately post intervention
Secondary outcome [2] 0 0
Importance of physical activity
Timepoint [2] 0 0
Immediately post intervention
Secondary outcome [3] 0 0
Knee OA knowledge
Timepoint [3] 0 0
Immediately post intervention
Secondary outcome [4] 0 0
Perceived change in feelings about having knee OA
Timepoint [4] 0 0
Immediately post intervention
Secondary outcome [5] 0 0
Perceived personal likelihood of ever needing knee surgery
Timepoint [5] 0 0
Immediately post intervention
Secondary outcome [6] 0 0
Motivation to be physically active
Timepoint [6] 0 0
Immediately post intervention

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.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/02/2022
Sample size
Target
Accrual to date
Final
589
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05156216
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.
Public notes

Contacts
Principal investigator
Name 0 0
Thorlene Egerton, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05156216