NCT06904885

Brief 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. 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Apr 2025

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Apr 2025Dec 2035

First Submitted

Initial submission to the registry

March 3, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
8.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

March 3, 2025

Last Update Submit

March 31, 2025

Conditions

Keywords

osteoarthritisimplementationbenchmarking controlled trialmodel of carecare pathway

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    1 (primary endpoint) 3 and 5 years after implementation

Secondary Outcomes (20)

  • Number of trained GLA:D trainers and physiotherapists

    1, 3 and 5 years after implementation

  • Participation of patients in GLA:D program

    1, 3 and 5 years after implementation

  • Pain intensity during last week, numerical rating scale

    Baseline, 3 months, 1, 3 and 10 years

  • Problems walking due to knee /hip

    Baseline, 3 months, 1, 3 and 10 years

  • UCLA activity score

    Baseline, 3 months, 1, 3 and 10 years

  • +15 more secondary outcomes

Other Outcomes (16)

  • The Determinants of Implementation Behaviour Questionnaire

    after delivering first GLA:D program and at 12 months

  • Gender

    Baseline

  • Age

    Baseline

  • +13 more other outcomes

Study Arms (4)

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.

Interventions

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.

GLA:D -trained physiotherapists

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patients who are participating in theGLA:D program, diagnosed with hip or knee osteoarthritis, fluent in finnish
  • age over 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis

Interventions

Papaverine

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

BenzylisoquinolinesAlkaloidsHeterocyclic CompoundsOpiate AlkaloidsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Riikka T Holopainen, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visiting researcher

Study Record Dates

First Submitted

March 3, 2025

First Posted

April 1, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 1, 2035

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share