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Knee OsteoarthritisvidEONCT05156216

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

A study testing Patient education in people with Knee Osteoarthritis and Patient Empowerment, run by University of Melbourne at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Knee Osteoarthritis, Patient Empowerment
What is being tested?
Patient education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
589 participants
Where
1 siteAustralia
Study dates
1 Nov 2021to 15 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • The University of Melbourne

    Melbourne, Victoria, 3010

Other trials in Australia

About this study

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

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.

Being tested
Patient education
Keywords
knee osteoarthritis, patient education, health information, empowerment discourse, video, randomised controlled trial
Medical subject headings
Osteoarthritis, Knee, Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient educationOther

    Also called Health information

    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.

Study groups in NCT05156216
Study groupRoleWhat they receive
Experimental videoExperimentalKnee OA educational video based on an empowerment discourse delivered online and embedded within the survey.
Receives: Other: Patient education
Control videoActive comparatorKnee OA educational video based on a disease and impairment discourse delivered online and embedded within the survey.
Receives: Other: Patient education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Immediately post intervention

  2. 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.

    Measured: Immediately post intervention

Secondary outcomes (6)

  1. 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.

    Measured: Immediately post intervention

  2. 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.

    Measured: Immediately post intervention

  3. 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.

    Measured: Immediately post intervention

  4. 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'.

    Measured: Immediately post intervention

  5. 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.

    Measured: Immediately post intervention

  6. 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.

    Measured: Immediately post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2021
  2. Study start1 Nov 2021
  3. Primary completion24 Nov 2021
  4. Study completion15 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomised to one of two groups (1:1) using the randomiser function in Qualtrics (set to 'evenly present elements').
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
589 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05156216
Sponsor's protocol ID
CT21063
Other IDs
U1111-1269-6143
Acronym
vidEO
Status last verified
May 2022
First submitted
10 Nov 2021
Last updated
18 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 35750241

Questions about this trial

What is this clinical trial studying?

A study testing Patient education in people with Knee Osteoarthritis and Patient Empowerment, run by University of Melbourne at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-efficacy for managing pain from osteoarthritis (time frame: Immediately post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05156216, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.

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