Comparative Effect of Two Educational Videos for People With Knee Osteoarthritis (vidEO)

Knee Osteoarthritis Clinical Trial

— vidEO  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05156216
• Other study ID #: CT21063
• Secondary ID: U1111-1269-6143
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: February 15, 2022

Study information

• Verified date: May 2022
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: February 15, 2022
• Est. primary completion date: November 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Patient Empowerment

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Australia	The University of Melbourne	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
University of Melbourne

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Novelty check	Have you seen the video before? Yes/no	Immediately post intervention
Other	Fidelity check	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; = Watched it once through to the end; = Watched it more than once through to the end	Immediately post intervention
Other	Satisfaction with the video education	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
Primary	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
Primary	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	Expectations about their knee OA prognosis and benefit from physical activity	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
Secondary	Importance of physical activity	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
Secondary	Knee OA knowledge	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
Secondary	Perceived change in feelings about having knee OA	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
Secondary	Perceived personal likelihood of ever needing knee surgery	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
Secondary	Motivation to be physically active	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