Osteoarthritis of the Hip or KneeFIN-OANCT06904885
Implementing a Guideline-based Model of Care for Hip and Knee Osteoarthritis in Finland. A Benchmarking-controlled Trial (FIN-OA)
An observational study of Osteoarthritis of the Hip or Knee, run by University of Jyvaskyla.
Trial summary
This project aims to bridge the gap between guideline recommendations and clinical practice in osteoarthritis (OA) management. By implementing a systematic, evidence-based model of care, the project seeks to improve patient outcomes, reduce healthcare costs, and provide equitable access to care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Hip or Knee
- What is being tested?
- Implementation of a guideline-based model of care for hip and knee osteoarthritis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to Dec 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: National registry data: Patients with diagnosed OA from all Wellbeing Services Counties in Finland GLA:D patient-reported outcome data: Patients who are participating in the GLA:D program, diagnosed with hip or knee osteoarthritis in any location that delivers GLA:D program.
Who may be able to join
- Patients who are participating in theGLA:D program, diagnosed with hip or knee osteoarthritis, fluent in finnish
- age over 18 years
Who cannot join
- Other than OA-related cause of symptoms
- not able to answer the questionnaires in Finnish
- no access to a computer or mobile device to answer the questionnaires
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This project aims to bridge the gap between guideline recommendations and clinical practice in osteoarthritis (OA) management. By implementing a systematic, evidence-based model of care, the project seeks to improve patient outcomes, reduce healthcare costs, and provide equitable access to care. The project consists of three phases. In the first phase the current OA care is mapped through registry review and questionnaires and interviews of patients and healthcare professionals. In the second, implementation phase of the project, a plan will be created how to support healthcare professionals in delivering care according to the new model of care and training and support will be offered according to the plan. In the third phase of the project, the implementation success will be evaluated, and the costs of OA care evaluated and compared to baseline data. In addition, patient-reported data will be collected from those patients, who participate in the group-based exercise and education program.
Read the detailed description
Osteoarthritis (OA) is a growing global health challenge, due to the significant increase in prevalence of knee and hip OA. In Finland, OA care costs are substantial, driven by diagnostic procedures, medical treatments, and indirect costs such as work absenteeism. The international guidelines recommend education, exercise, and weight management as first-line treatment options, but adherence to guidelines is inconsistent. This project aims to explore regional differences in OA care and beliefs and OA care practices in Finland. In addition, we will implement and evaluate a guideline-based model of care for hip and knee OA, that includes the Good Life with osteoarthritis from Denmark (GLA:D®) program as the preferred non-surgical management option in local care pathways. In addition, the aim is to share evidence-based OA knowledge and management skills nationwide.
This study is a hybrid type-3 benchmarking-controlled implementation trial. It is nested in primary healthcare in two Wellbeing Services Counties. The study includes three phases: pre-implementation, implementation, and evaluation. The pre-implementation activities include mapping the current OA care through registry review (healthcare utilization and costs from 2019-2024). In addition questionnaires and interviews of patients and healthcare professionals (beliefs and practices) will be conducted. Planned activities of the implementation phase include developing and integrating a new model of care (including GLA:D®) into local care pathways, and training physiotherapists to deliver it. Implementation theories and multifaceted implementation strategies will be used and adapted locally. The activities to evaluate the process include assessment of the implementation outcomes on healthcare professional and organizational levels, healthcare resource utilization and cost outcomes (1, 3 and 5 years) using registry data. In addition outcomes reported by patients participating in the GLA:D program will be collected at 3 months and 1, 3 and 10 years.
This project aims to bridge the gap between guideline-recommended OA-management and clinical practice. By implementing a systematic, evidence-based model of care, the study seeks to improve patient outcomes, reduce healthcare costs, and provide equitable access to care. The findings will inform future OA care strategies and will be disseminated and adapted to other healthcare contexts in Finland and can be adapted also internationally. The findings will be published in peer-reviewed journals and presented in national and international conferences.
- Conditions
- Osteoarthritis of the Hip or Knee
- Being tested
- Implementation of a guideline-based model of care for hip and knee osteoarthritis
- Keywords
- osteoarthritis, implementation, benchmarking controlled trial, model of care, care pathway
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of a guideline-based model of care for hip and knee osteoarthritisBehavioural
Guideline-based model of care including GLA:D (Good Life with osteoArthritis from Denmark) -program that includes training for physiotherapists and group based education and exercise for patients with hip and knee OA.
| Study group | Role | What they receive |
|---|---|---|
| Patients participating GLA:D program | Not described | |
| GLA:D -trained physiotherapists | Not described Receives: Behavioral: Implementation of a guideline-based model of care for hip and knee osteoarthritis | |
| Registry data from national registries (pre) | Data of people with hip or knee OA from national registries from all Wellbeing Services Counties in Finland before the implementation of new model of care. | |
| Registry data from national registries (post) | Data of people with hip or knee OA from national registries from all Wellbeing Services Counties in Finland after the implementation of new model of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of OA care
Healthcare cost associated with the new care pathway incluing annual healthcare consultation prevalence, number and cost of hospitalizations, OA-related surgical interventions and primary and specialized healthcare and outpatient specialist visits. Filled prescriptions, number and duration of OA-related sick leaves and disability pensions. Costs will be analysed using data from national registers in pre and post implementation, both within the pilot Wellbeing Services Counties and between the pilot and other Wellbeing Services Counties.
Measured: 1 (primary endpoint), 3 and 5 years after implementation compared to baseline 2018-2024
Reach: Proportion of patients directed according to the model of care
Proportion of patients with hip and knee related symptoms and OA who contact healthcare that are referred to direct access physiotherapy and to GLA:D program
Measured: 1 (primary endpoint) 3 and 5 years after implementation
Secondary outcomes (20)
Number of trained GLA:D trainers and physiotherapists
Number of trained GLA:D trainers and physiotherapists in Finland, recorded in GLA:D Finland database by PI.
Measured: 1, 3 and 5 years after implementation
Participation of patients in GLA:D program
Number of participants in GLA:D groups
Measured: 1, 3 and 5 years after implementation
Pain intensity during last week, numerical rating scale
Numerical rating scale (NRS) 0-10, where 0 means no pain (better outcome) and 10 worst possible pain (worse outcome). a) worst pain b) average pain
Measured: Baseline, 3 months, 1, 3 and 10 years
Problems walking due to knee /hip
yes / no
Measured: Baseline, 3 months, 1, 3 and 10 years
UCLA activity score
UCLA activity score, 1= wholly inactive (worse outcome), 10 = regularly participate in impact sports (better outcome)
Measured: Baseline, 3 months, 1, 3 and 10 years
Fear of movement
Are you afraid that your joints will be damaged from physical activity and exercise? yes / no
Measured: Baseline, 3 months, 1, 3 and 10 years
Use of painkillers
Yes / no, and type of pain killers
Measured: Baseline, 3 months, 1, 3 and 10 years
Current employment
Employed / student / unemployed / on sick leave full time / on sick leave part time / early retirement due to low ability to work / self-imposed early retirement / retired
Measured: Baseline, 3 months, 1, 3 and 10 years
Sick leave because of knee / hip during last year
no / yes, under 1 month, yes 1-3 months, yes more than 3 months
Measured: Baseline, 3 months, 1, 3 and 10 years
EQ-5D-5L
Mobility (1-5), self-care (1-5), usual activities (1-5), pain/ discomfort (1-5), anxiety / depression (1-5), eq-vas (0-100). Lower scores indicate a worse outcome.
Measured: Baseline, 3 months, 1, 3 and 10 years
K/HOOS-12
KOOS-12 asked if most affected joint is knee and HOOS-12 asked is most affected joint is hip. Scale 1-4 for each item, a lower score indicates a better outcome.
Measured: Baseline, 3 months, 1, 3 and 10 years
Global perceived effect
Much worse, an important worsening - much better an important improvement. 7-point likert scale, where a higher score indicates a better outcome.
Measured: 3 months, 1, 3 and 10 years
Satisfaction with GLA:D
1-5 Not at all satisfied - very satisfied, higher score indicates a better outcome.
Measured: 3 and 12 months
How often do you use what you've learned in GLA:D?
Never (1), every month (2), every week (3), every day (4), several times a day (5), a higher score indicates a better outcome.
Measured: 3 months, 1, 3 and 10 years
Number of education and exercise sessions competed (face to face / online)
Numeral value
Measured: 3 months
Falls over the last year
Number of falls
Measured: Baseline, 3 months, 1, 3 and 10 years
Compliance in GLA:D program
Number of participated GLA:D sessions / participant.
Measured: 3 months
Numbers of sites training / implementing GLA:D -program
Number of sites training / implementing GLA:D -program in Finland. In numbers, based on documentation on GLA:D database by PI.
Measured: 1, 3 and 5 years after implementation
Number of GLA:D groups running
Number of active GLA:D groups running, numbers, based on documentation on GLA:D Finland database by PI.
Measured: 1, 3 and 5 years after implementation
Modifications in the Model of care
Descriptive qualitative reporting based on research diary: When and how modifactions in the Model of Care and Care pathways occured, whether it was unplanned or planned, reasons and goals for modification.
Measured: 1, 3 and 5 years after implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the Hip or 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, University of Oulu, University of Helsinki, Tampere University, University of Limerick
- Responsible party
- Principal investigator, Riikka Holopainen, University of Jyvaskyla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904885
- Sponsor's protocol ID
- 263/13.00.04.00/2025
- Acronym
- FIN-OA
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 3 Apr 2025
- 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 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Guideline-based Model of Care for Hip and Knee Osteoarthritis in Finland. A Benchmarking-controlled Trial (FIN-OA)
- ClinicalTrials.gov ID
- NCT06904885
- Acronym / sponsor ID
- FIN-OA / 263/13.00.04.00/2025
- Conditions
- Osteoarthritis of the Hip or Knee
- Keywords
- osteoarthritis, implementation, benchmarking controlled trial, model of care, care pathway
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Collaborators
- University of Southern Denmark, University of Oulu, University of Helsinki, Tampere University, University of Limerick
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 1 Apr 2025 (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.
This project aims to bridge the gap between guideline recommendations and clinical practice in osteoarthritis (OA) management. By implementing a systematic, evidence-based model of care, the project seeks to improve patient outcomes, reduce healthcare costs, and provide equitable access to care. The project consists of three phases. In the first phase the current OA care is mapped through registry review and questionnaires and interviews of patients and healthcare professionals. In the second, implementation phase of the project, a plan will be created how to support healthcare professionals in delivering care according to the new model of care and training and support will be offered according to the plan. In the third phase of the project, the implementation success will be evaluated, and the costs of OA care evaluated and compared to baseline data. In addition, patient-reported data will be collected from those patients, who participate in the group-based exercise and education program.
Detailed description
Osteoarthritis (OA) is a growing global health challenge, due to the significant increase in prevalence of knee and hip OA. In Finland, OA care costs are substantial, driven by diagnostic procedures, medical treatments, and indirect costs such as work absenteeism. The international guidelines recommend education, exercise, and weight management as first-line treatment options, but adherence to guidelines is inconsistent. This project aims to explore regional differences in OA care and beliefs and OA care practices in Finland. In addition, we will implement and evaluate a guideline-based model of care for hip and knee OA, that includes the Good Life with osteoarthritis from Denmark (GLA:D®) program as the preferred non-surgical management option in local care pathways. In addition, the aim is to share evidence-based OA knowledge and management skills nationwide.
This study is a hybrid type-3 benchmarking-controlled implementation trial. It is nested in primary healthcare in two Wellbeing Services Counties. The study includes three phases: pre-implementation, implementation, and evaluation. The pre-implementation activities include mapping the current OA care through registry review (healthcare utilization and costs from 2019-2024). In addition questionnaires and interviews of patients and healthcare professionals (beliefs and practices) will be conducted. Planned activities of the implementation phase include developing and integrating a new model of care (including GLA:D®) into local care pathways, and training physiotherapists to deliver it. Implementation theories and multifaceted implementation strategies will be used and adapted locally. The activities to evaluate the process include assessment of the implementation outcomes on healthcare professional and organizational levels, healthcare resource utilization and cost outcomes (1, 3 and 5 years) using registry data. In addition outcomes reported by patients participating in the GLA:D program will be collected at 3 months and 1, 3 and 10 years.
This project aims to bridge the gap between guideline-recommended OA-management and clinical practice. By implementing a systematic, evidence-based model of care, the study seeks to improve patient outcomes, reduce healthcare costs, and provide equitable access to care. The findings will inform future OA care strategies and will be disseminated and adapted to other healthcare contexts in Finland and can be adapted also internationally. The findings will be published in peer-reviewed journals and presented in national and international conferences.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients participating GLA:D program | – | – |
| GLA:D -trained physiotherapists | – | Behavioral: Implementation of a guideline-based model of care for hip and knee osteoarthritis |
| Registry data from national registries (pre) | – | –Data of people with hip or knee OA from national registries from all Wellbeing Services Counties in Finland before the implementation of new model of care. |
| Registry data from national registries (post) | – | –Data of people with hip or knee OA from national registries from all Wellbeing Services Counties in Finland after the implementation of new model of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- National registry data: Patients with diagnosed OA from all Wellbeing Services Counties in Finland GLA:D patient-reported outcome data: Patients who are participating in the GLA:D program, diagnosed with hip or knee osteoarthritis in any location that delivers GLA:D program.
Key inclusion criteria (2 listed)
- Patients who are participating in theGLA:D program, diagnosed with hip or knee osteoarthritis, fluent in finnish
- age over 18 years
Key exclusion criteria (3 listed)
- Other than OA-related cause of symptoms
- not able to answer the questionnaires in Finnish
- no access to a computer or mobile device to answer the questionnaires
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 a guideline-based model of care for hip and knee osteoarthritisGuideline-based model of care including GLA:D (Good Life with osteoArthritis from Denmark) -program that includes training for physiotherapists and group based education and exercise for patients with hip and knee OA. | Behavioural | GLA:D -trained physiotherapists |
Primary outcome
Cost of OA care
Time frame: 1 (primary endpoint), 3 and 5 years after implementation compared to baseline 2018-2024
Healthcare cost associated with the new care pathway incluing annual healthcare consultation prevalence, number and cost of hospitalizations, OA-related surgical interventions and primary and specialized healthcare and outpatient specialist visits. Filled prescriptions, number and duration of OA-related sick leaves and disability pensions. Costs will be analysed using data from national registers in pre and post implementation, both within the pilot Wellbeing Services Counties and between the pilot and other Wellbeing Services Counties.
Reach: Proportion of patients directed according to the model of care
Time frame: 1 (primary endpoint) 3 and 5 years after implementation
Proportion of patients with hip and knee related symptoms and OA who contact healthcare that are referred to direct access physiotherapy and to GLA:D program
20 secondary outcomes
Number of trained GLA:D trainers and physiotherapists
Time frame: 1, 3 and 5 years after implementation
Participation of patients in GLA:D program
Time frame: 1, 3 and 5 years after implementation
Pain intensity during last week, numerical rating scale
Time frame: Baseline, 3 months, 1, 3 and 10 years
Problems walking due to knee /hip
Time frame: Baseline, 3 months, 1, 3 and 10 years
UCLA activity score
Time frame: Baseline, 3 months, 1, 3 and 10 years
Fear of movement
Time frame: Baseline, 3 months, 1, 3 and 10 years
Use of painkillers
Time frame: Baseline, 3 months, 1, 3 and 10 years
Current employment
Time frame: Baseline, 3 months, 1, 3 and 10 years
Sick leave because of knee / hip during last year
Time frame: Baseline, 3 months, 1, 3 and 10 years
EQ-5D-5L
Time frame: Baseline, 3 months, 1, 3 and 10 years
K/HOOS-12
Time frame: Baseline, 3 months, 1, 3 and 10 years
Global perceived effect
Time frame: 3 months, 1, 3 and 10 years
Satisfaction with GLA:D
Time frame: 3 and 12 months
How often do you use what you've learned in GLA:D?
Time frame: 3 months, 1, 3 and 10 years
Number of education and exercise sessions competed (face to face / online)
Time frame: 3 months
Falls over the last year
Time frame: Baseline, 3 months, 1, 3 and 10 years
Compliance in GLA:D program
Time frame: 3 months
Numbers of sites training / implementing GLA:D -program
Time frame: 1, 3 and 5 years after implementation
Number of GLA:D groups running
Time frame: 1, 3 and 5 years after implementation
Modifications in the Model of care
Time frame: 1, 3 and 5 years after implementation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis of the Hip or Knee, run by University of Jyvaskyla.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riikka T Holopainen, PhD (+358401696566, riikka.holopainen@movedoc.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost of OA care (time frame: 1 (primary endpoint), 3 and 5 years after implementation compared to baseline 2018-2024). 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?
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 3 Apr 2025.