Osteoarthritis, KneeNCT04670549
Improve Osteoarthritis Care
A study testing Implementation of treatment guidelines in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial summary
The purpose of The Improve Osteoarthritis Care study is to improve the quality of osteoarthritis care in Norwegian primary care, by increasing the use of recommended treatment modalities and improving patient access to recommended treatments. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Implementation of treatment guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,541 participants
- Where
- 1 siteNorway
- Study dates
- 13 Nov 2020to 1 Jul 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Self-reported hip or knee osteoarthritis
Who cannot join
- Persons who do not understand the Norwegian language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Improve Osteoarthritis Care Study
The purpose of The Improve Osteoarthritis Care study is to improve the quality of osteoarthritis care in Norwegian primary care, by increasing the use of recommended treatment modalities and improving patient access to recommended treatments. The study will use tailored implementation strategies, targeting primary care physicians and physiotherapists to improve knowledge and addressing individual barriers to providing recommended treatments.
Read the detailed description
Previous research has shown that current osteoarthritis care for persons with hip or knee osteoarthritis (OA) in Norway has a potential for improvement as the provided care may not necessarily reflect evidence-based guideline recommendations. The overall purpose of the "Improve Osteoarthritis Care" study is that people with symptomatic hip and knee OA should receive care in line with current recommendations. To achieve this goal, tailored implementation strategies will be applied in order to: 1) Improve the quality of care offered to people with symptomatic hip and knee OA, 2) increase knowledge of recommended OA care among people with hip and knee OA, 3) Increase the number of primary care physiotherapists' offering group-based patient-education and structured exercise as part of their routine clinical practice, 4) Increase the number of general practitioners who have received a summary of the OA treatment recommendations.
To evaluate the effect of the tailored implementation strategy a pre-post design will be applied, and members of the Norwegian Rheumatology Association with self-reported hip or knee OA will be asked to evaluate quality of OA care at the two timepoints.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Implementation of treatment guidelines
- Keywords
- Implementation, Treatment guidelines
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of treatment guidelinesOther
To improve knowledge of OA treatment recommendations among people with hip and knee OA, a lay language summary will be emailed all OA patient participants. A second summary of the treatment recommendations, targeting general practitioners (GPs) will also be emailed the OA patient participants. The patients will be encouraged to print and bring this summary to their GP at the next visit (user-initiated implementation). Barriers and facilitators for providing evidence-based OA care among primary care physiotherapists will be mapped through interviews. Thereafter, a tool-kit of strategies and practical aids intended to help overcome these barriers will be developed and made available for the physiotherapists.
| Study group | Role | What they receive |
|---|---|---|
| Pre and post implementation phases | Other | Pre-implementation phase: during the pre-implementation period persons with hip or knee osteoarthritis will receive "usual care" as it is currently delivered by physiotherapists and general practitioners.
Post-implementation phase: during the post-implementation phase patients with hip and knee OA will receive OA care more in line with the treatment recommendations. Receives: Other: Implementation of treatment guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
The OsteoArthritis Quality Indicator questionnaire (OA-QI), version 2
Assess change in patient-reported quality of OA care (mean total pass rate, 0-100 (best score))
Measured: 18 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start13 Nov 2020
- Primary completion9 Feb 2023
- Study completion1 Jul 2023
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
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post design
- Masking
- None (open label)
- Enrolment
- 1,541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Osteras, Diakonhjemmet Hospital
- Investigators
- Nina Østerås, Principal investigator, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670549
- Sponsor's protocol ID
- DS 00203
- Status last verified
- Dec 2023
- First submitted
- 10 Dec 2020
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improve Osteoarthritis Care Study
- ClinicalTrials.gov ID
- NCT04670549
- Acronym / sponsor ID
- DS 00203
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- Implementation, Treatment guidelines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,541 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 17 Dec 2020 (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 purpose of The Improve Osteoarthritis Care study is to improve the quality of osteoarthritis care in Norwegian primary care, by increasing the use of recommended treatment modalities and improving patient access to recommended treatments. The study will use tailored implementation strategies, targeting primary care physicians and physiotherapists to improve knowledge and addressing individual barriers to providing recommended treatments.
Detailed description
Previous research has shown that current osteoarthritis care for persons with hip or knee osteoarthritis (OA) in Norway has a potential for improvement as the provided care may not necessarily reflect evidence-based guideline recommendations. The overall purpose of the "Improve Osteoarthritis Care" study is that people with symptomatic hip and knee OA should receive care in line with current recommendations. To achieve this goal, tailored implementation strategies will be applied in order to: 1) Improve the quality of care offered to people with symptomatic hip and knee OA, 2) increase knowledge of recommended OA care among people with hip and knee OA, 3) Increase the number of primary care physiotherapists' offering group-based patient-education and structured exercise as part of their routine clinical practice, 4) Increase the number of general practitioners who have received a summary of the OA treatment recommendations.
To evaluate the effect of the tailored implementation strategy a pre-post design will be applied, and members of the Norwegian Rheumatology Association with self-reported hip or knee OA will be asked to evaluate quality of OA care at the two timepoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post design
| Arm | Type | Receives |
|---|---|---|
| Pre and post implementation phases | Other | Other: Implementation of treatment guidelinesPre-implementation phase: during the pre-implementation period persons with hip or knee osteoarthritis will receive "usual care" as it is currently delivered by physiotherapists and general practitioners. Post-implementation phase: during the post-implementation phase patients with hip and knee OA will receive OA care more in line with the treatment recommendations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Self-reported hip or knee osteoarthritis
Key exclusion criteria (1 listed)
- Persons who do not understand the Norwegian language
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 |
|---|---|---|
| Implementation of treatment guidelinesTo improve knowledge of OA treatment recommendations among people with hip and knee OA, a lay language summary will be emailed all OA patient participants. A second summary of the treatment recommendations, targeting general practitioners (GPs) will also be emailed the OA patient participants. The patients will be encouraged to print and bring this summary to their GP at the next visit (user-initiated implementation). Barriers and facilitators for providing evidence-based OA care among primary care physiotherapists will be mapped through interviews. Thereafter, a tool-kit of strategies and practical aids intended to help overcome these barriers will be developed and made available for the physiotherapists. | Other | Pre and post implementation phases |
Primary outcome
The OsteoArthritis Quality Indicator questionnaire (OA-QI), version 2
Time frame: 18 months follow-up
Assess change in patient-reported quality of OA care (mean total pass rate, 0-100 (best score))
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 21 Dec 2023.
- 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.
Nina Østerås principal investigator
Diakonhjemmet Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of treatment guidelines in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Diakonhjemmet Hospital at 1 site in Norway.
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 1 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 21 Dec 2023. 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 Norway. 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?
The OsteoArthritis Quality Indicator questionnaire (OA-QI), version 2 (time frame: 18 months follow-up). 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 21 Dec 2023.