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

Primary Purpose

Knee Osteoarthritis, Patient Empowerment

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Patient education
Sponsored by
University of Melbourne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, patient education, health information, empowerment discourse, video, randomised controlled trial

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Melbourne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental video

Control video

Arm Description

Knee OA educational video based on an empowerment discourse delivered online and embedded within the survey.

Knee OA educational video based on a disease and impairment discourse delivered online and embedded within the survey.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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'.
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.
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.

Full Information

First Posted
November 10, 2021
Last Updated
May 16, 2022
Sponsor
University of Melbourne
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1. Study Identification

Unique Protocol Identification Number
NCT05156216
Brief Title
Comparative Effect of Two Educational Videos for People With Knee Osteoarthritis (vidEO)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 24, 2021 (Actual)
Study Completion Date
February 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Melbourne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Patient Empowerment
Keywords
knee osteoarthritis, patient education, health information, empowerment discourse, video, randomised controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
Limited disclosure will be used to blind participants and thereby reduce bias in responses since participants are also the assessors as all outcome measurements are self-reported. Participants will simply be informed that the trial aim is to assess knee OA educational videos. The investigators will not disclose details about how the educational content/presentation of the two videos differ, nor the hypotheses of the study. The biostatistician who performs the data analysis will be blinded.
Allocation
Randomized
Enrollment
589 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental video
Arm Type
Experimental
Arm Description
Knee OA educational video based on an empowerment discourse delivered online and embedded within the survey.
Arm Title
Control video
Arm Type
Active Comparator
Arm Description
Knee OA educational video based on a disease and impairment discourse delivered online and embedded within the survey.
Intervention Type
Other
Intervention Name(s)
Patient education
Other Intervention Name(s)
Health information
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-efficacy for managing pain from osteoarthritis
Description
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.
Time Frame
Immediately post intervention
Title
Kinesiophobia
Description
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.
Time Frame
Immediately post intervention
Secondary Outcome Measure Information:
Title
Expectations about their knee OA prognosis and benefit from physical activity
Description
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.
Time Frame
Immediately post intervention
Title
Importance of physical activity
Description
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.
Time Frame
Immediately post intervention
Title
Knee OA knowledge
Description
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.
Time Frame
Immediately post intervention
Title
Perceived change in feelings about having knee OA
Description
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'.
Time Frame
Immediately post intervention
Title
Perceived personal likelihood of ever needing knee surgery
Description
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.
Time Frame
Immediately post intervention
Title
Motivation to be physically active
Description
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.
Time Frame
Immediately post intervention
Other Pre-specified Outcome Measures:
Title
Novelty check
Description
Have you seen the video before? Yes/no
Time Frame
Immediately post intervention
Title
Fidelity check
Description
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
Time Frame
Immediately post intervention
Title
Satisfaction with the video education
Description
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.
Time Frame
Immediately post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thorlene Egerton, PhD
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3010
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35750241
Citation
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.
Results Reference
derived

Learn more about this trial

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

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