Osteoarthritis, KneeNCT04698655
Influence of Osteoarthritis Information on Treatment Beliefs
A study testing Information on treatment options, Recommendation from general practitioner and Information on osteoarthritis in people with Osteoarthritis, Knee, run by University of Melbourne at 1 site in Australia.
Trial summary
The aim of this study is to evaluate the effect of educational information, with and without a general practitioner recommendation to exercise, on willingness to undertake exercise/physical activity for knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Information on treatment options, Recommendation from general practitioner and Information on osteoarthritis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 735 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Mar 2021to 5 Apr 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 45+ years
Who cannot join
- Been told by a health professional that they have osteoarthritis in any joint/anywhere in the body
- Have experienced any knee pain in the prior 3 months
- Unable to read English
- Have had a joint replacement in any knee or hip joint
- Have any health condition that makes unable to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Osteoarthritis eDucational Information and General Practitioner Endorsement on ExerCISe IntentiONs, Beliefs and Willingness to Exercise: the DECISION Randomised Controlled Trial.
The aim of this study is to evaluate the effect of educational information, with and without a general practitioner recommendation to exercise, on willingness to undertake exercise/physical activity for knee osteoarthritis. Eligible participants will be aged 45+ years and will not currently have osteoarthritis, knee pain, or any condition that makes them unable to exercise. Participants will be asked to complete an online survey, during which they will be randomised to one of three groups and shown different types of educational information to read. Outcome measures will be collected as part of the survey before and after participants read the educational information presented to them.
Read the detailed description
3-arm superiority online randomised controlled trial (delivered within one survey). Participants will complete an online survey, during which they will be presented with a hypothetical scenario asking them to imagine that they had recently developed knee pain and have gone to see their general practitioner. Participants will then be randomised to one of 3 different groups (described below). Each group will be shown different types of educational material and asked to read the information carefully. Once they have finished reading the material, they will be asked to complete follow-up outcome measures to determine whether their beliefs about osteoarthritis management strategies have changed.
The 3 trial groups are:
- Control group: asked to read a single-A4 page of brief osteoarthritis information ("what is osteoarthritis"); II. Treatment options group: asked to read brief osteoarthritis information + two A4 pages of information on treatment options ("osteoarthritis treatment options"), and; III. Treatment options + recommendation group: asked to read brief osteoarthritis information + information on treatment options + receive a hypothetical GP recommendation for exercise
- Conditions
- Osteoarthritis, Knee
- Being tested
- Information on treatment options, Recommendation from general practitioner, Information on osteoarthritis
- Keywords
- Osteoarthritis, Knee, Education, Decision aid, Beliefs
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information on treatment optionsOther
Asked to read two A4 pages of information on treatment options ("osteoarthritis treatment options")
Recommendation from general practitionerOther
Receive a hypothetical general practitioner recommendation for exercise
Information on osteoarthritisOther
Asked to read 1 A4 page of brief information on osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Asked to read a single-A4 page of brief osteoarthritis information ("what is osteoarthritis") Receives: Other: Information on osteoarthritis |
| Treatment options group | Experimental | Asked to read brief osteoarthritis information + two A4 pages of information on treatment options ("osteoarthritis treatment options") Receives: Other: Information on treatment options; Other: Information on osteoarthritis |
| Treatment options + recommendation group | Experimental | Asked to read brief osteoarthritis information + information on treatment options + receive hypothetical general practitioner recommendation for exercise Receives: Other: Information on treatment options; Other: Recommendation from general practitioner; Other: Information on osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Belief that an exercise or physical activity program is the most appropriate management option for their knee
Measured on an 11-point scale (0 = strongly disagree 10 = strongly agree)
Measured: Immediately after reading educational information in survey
Secondary outcomes (3)
Belief surgery, weight loss, x-rays, injections and medications are the most appropriate management options for their knee
Measured on an 11-point scale (0 = strongly disagree 10 = strongly agree)
Measured: Immediately after reading educational information in survey
Intentions to request a referral to an orthopedic surgeon, physiotherapist, and dietitian or to request prescription for medications, an injection, and an x-ray for their knee
Measured on an 11-point scale (0 = definitely would not 10 = definitely would)
Measured: Immediately after reading educational information in survey
Belief about the effectiveness of surgery, weight loss, x-rays, injections and medications for people with knee osteoarthritis
Measured on an 11-point scale (0 = strongly disagree 10 = strongly agree)
Measured: Immediately after reading educational information in survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start24 Mar 2021
- Primary completion5 Apr 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 735 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belinda Lawford, University of Melbourne
- Investigators
- Belinda J Lawford, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698655
- Sponsor's protocol ID
- 20744
- Status last verified
- Apr 2021
- First submitted
- 13 Dec 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Osteoarthritis eDucational Information and General Practitioner Endorsement on ExerCISe IntentiONs, Beliefs and Willingness to Exercise: the DECISION Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT04698655
- Acronym / sponsor ID
- 20744
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Education, Decision aid, Beliefs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 735 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effect of educational information, with and without a general practitioner recommendation to exercise, on willingness to undertake exercise/physical activity for knee osteoarthritis. Eligible participants will be aged 45+ years and will not currently have osteoarthritis, knee pain, or any condition that makes them unable to exercise. Participants will be asked to complete an online survey, during which they will be randomised to one of three groups and shown different types of educational information to read. Outcome measures will be collected as part of the survey before and after participants read the educational information presented to them.
Detailed description
3-arm superiority online randomised controlled trial (delivered within one survey). Participants will complete an online survey, during which they will be presented with a hypothetical scenario asking them to imagine that they had recently developed knee pain and have gone to see their general practitioner. Participants will then be randomised to one of 3 different groups (described below). Each group will be shown different types of educational material and asked to read the information carefully. Once they have finished reading the material, they will be asked to complete follow-up outcome measures to determine whether their beliefs about osteoarthritis management strategies have changed.
The 3 trial groups are:
- Control group: asked to read a single-A4 page of brief osteoarthritis information ("what is osteoarthritis"); II. Treatment options group: asked to read brief osteoarthritis information + two A4 pages of information on treatment options ("osteoarthritis treatment options"), and; III. Treatment options + recommendation group: asked to read brief osteoarthritis information + information on treatment options + receive a hypothetical GP recommendation for exercise
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Information on osteoarthritisAsked to read a single-A4 page of brief osteoarthritis information ("what is osteoarthritis") |
| Treatment options group | Experimental | Other: Information on treatment options, Other: Information on osteoarthritisAsked to read brief osteoarthritis information + two A4 pages of information on treatment options ("osteoarthritis treatment options") |
| Treatment options + recommendation group | Experimental | Other: Information on treatment options, Other: Recommendation from general practitioner, Other: Information on osteoarthritisAsked to read brief osteoarthritis information + information on treatment options + receive hypothetical general practitioner recommendation for exercise |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 45+ years
Key exclusion criteria (5 listed)
- Been told by a health professional that they have osteoarthritis in any joint/anywhere in the body
- Have experienced any knee pain in the prior 3 months
- Unable to read English
- Have had a joint replacement in any knee or hip joint
- Have any health condition that makes unable to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information on treatment optionsAsked to read two A4 pages of information on treatment options ("osteoarthritis treatment options") | Other | Treatment options + recommendation group, Treatment options group |
| Recommendation from general practitionerReceive a hypothetical general practitioner recommendation for exercise | Other | Treatment options + recommendation group |
| Information on osteoarthritisAsked to read 1 A4 page of brief information on osteoarthritis | Other | Control group, Treatment options + recommendation group, Treatment options group |
Primary outcome
Belief that an exercise or physical activity program is the most appropriate management option for their knee
Time frame: Immediately after reading educational information in survey
Measured on an 11-point scale (0 = strongly disagree 10 = strongly agree)
3 secondary outcomes
Belief surgery, weight loss, x-rays, injections and medications are the most appropriate management options for their knee
Time frame: Immediately after reading educational information in survey
Intentions to request a referral to an orthopedic surgeon, physiotherapist, and dietitian or to request prescription for medications, an injection, and an x-ray for their knee
Time frame: Immediately after reading educational information in survey
Belief about the effectiveness of surgery, weight loss, x-rays, injections and medications for people with knee osteoarthritis
Time frame: Immediately after reading educational information in survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Belinda J Lawford principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information on treatment options, Recommendation from general practitioner and Information on osteoarthritis in people with Osteoarthritis, Knee, 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 1 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 28 Apr 2021. 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?
Belief that an exercise or physical activity program is the most appropriate management option for their knee (time frame: Immediately after reading educational information in survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2021.