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CompletedNCT02333656Updated Feb 1, 2018

Management of Hip and Knee Osteoarthritis in Primary Health Care

An interventional study of New OA model in Hip Osteoarthritis and Knee Osteoarthritis, sponsored by Diakonhjemmet Hospital. Completed at 1 site in Norway. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2018-02-01.

Sponsored by Diakonhjemmet Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
393
Allocation
Randomized
Ages
45 Years and older
Sex
All
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Study summary

Previous research has shown that the osteoarthritis care for persons with hip or knee osteoarthritis in Norway has a potential for improvement as the provided care may not necessarily reflect evidence-based guideline recommendations. This study will determine if a new model for integrated osteoarthritis (OA) care in primary health care will result in improved quality of osteoarthritis care and health benefits for the patients (reduced pain and body weight, increased function and activity level) among patients with hip and/or knee osteoarthritis. Further, this study will examine if the new model reduce the number of unnecessary referrals to Magnetic Resonance Imaging (MRI) and to orthopaedic surgeons in secondary care, and if it increases the number of referrals to physiotherapy treatment and the number of discharge reports from the physiotherapists to the referring general practitioner.

Read the detailed description

A new model for integrated care for patients with hip and/or knee osteoarthritis (OA) in primary care will be developed and implemented. The purpose of the model is to improve quality of OA care in primary health care services by increasing the collaboration between health care professionals and across health care levels, providing an integrated care and a patient pathway, and facilitating an active and healthy lifestyle among individuals with OA. This implementation study represents a collaborative study between six municipalities and a hospital department aiming to fulfill the intentions of the Norwegian Health Care Coordination Reform. The main aim of the present study is to implement and perform process and effect evaluations of this new model for integrated OA care. The study design will be a cluster randomized controlled trial with a stepped wedge design. Six neighboring municipalities will constitute the six clusters, which will switch from control (current OA care) to intervention phase (new OA model) in a randomized order. All municipalities start the trial simultaneously and act as controls until the point in time they are randomized to crossover from control to intervention, and all municipalities have implemented the intervention by the end of inclusion. The method consists of two parts; 1) Identification of barriers/facilitators + development of the model and interventions, 2) Implementation of the new model (interactive workshops) with process and effect evaluations. Participants will be general practitioners and physiotherapists in primary care as well as people with hip or knee OA.

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Conditions studied

  • Hip Osteoarthritis
  • Knee Osteoarthritis
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In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 393 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Diakonhjemmet Hospital is the lead sponsor of 62 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Activity-related hip and/or knee pain/complaints AND
  • Clinical signs and symptoms corresponding to hip and/or knee OA OR radiologically diagnosed OA OR Registered in the medical journal with the ICPC codes L89 (osteoarthritis of the hip), L90 (osteoarthritis of knee), L91 (osteoarthritis not classified elsewhere), L13 (hip symptoms/complaints), L15 (knee symptoms/complaints) and/or L20 (joint symptoms/complaints not classified elsewhere).

Exclusion criteria

Exclusion Criteria:

  • Total hip or knee replacement in the actual joint(s) and no pain/complaints in the other hip or knee joint(s)
  • Inflammatory rheumatic diseases (e.g. rheumatoid arthritis, spondyloarthritis)
  • Malignant illness or other major conditions (i.e unstable cardiovascular disorders or lung disease, dementia) that restrict the ability to adhere to the recommended OA treatment
  • Do not understand the Norwegian language
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
393 participants (actual)

Study arms

  • No intervention
    Control group

    Usual care. The participants enrolled in the control period will receive OA treatment as it is currently offered in primary health care services.

  • Experimental
    Intervention group

    New OA model. Health professionals attend an interactive workshop, implementation of international recommendations for OA care, multidiciplinary collaboration

    Other: New OA model

Interventions

  • OtherNew OA model

    The general practitioners and the physiotherapists will attend an inter-active workshop and deliver osteoarthritis care in line with international recommendations for osteoarthritis treatment. The general practitioner will refer eligible patients to treatment by physiotherapists at "Healthy Living Center" or by physiotherapists in private practice. This treatment will include a standardized patient education program followed by structured exercise program with individual adjustments. The general practitioner will schedule a follow-up after the 12-week treatment and will receive a treatment report from the physiotherapist.

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What researchers measure

Primary outcomes

  1. Osteoarthritis Quality Indicator questionnaire

    Patient reported achievement of quality indicators for osteoarthritis care

    Time frame: 6 months

Secondary outcomes

  1. Pain

    Pain level in hip/knee past week

    Time frame: 6 months

  2. Joint stiffness

    Stiffness in the hip/knee past week

    Time frame: 6 months

  3. Global function

    Hip/knee function in the past week

    Time frame: 6 months

  4. Patient global assessment of the OA disease

    Time frame: 6 months

  5. Patient Acceptable Symptom State (PASS)

    Time frame: 6 months

  6. Hip/knee function, quality of living subscale

    Function (Knee injury and Osteoarthritis Outcome Score ADL subscale/ Hip disability and Osteoarthritis Outcome Score OoL subscale (K/HOOS)

    Time frame: 6 months

  7. Physical activity level

    An index based on self-reported frequency, intensity, duration of physical activity

    Time frame: 6 months

  8. Daily sitting

    Daily hours in sitting position

    Time frame: 6 months

  9. Satisfaction with the care provided

    Time frame: 6 months

  10. Health related quality of life (EQ-5D)

    Time frame: 6 months

  11. Self-reported body weight

    Time frame: 6 months

  12. Health care use, medication use and sick leave

    Time frame: 6 months

  13. Adverse events

    Time frame: Up to 1 year

  14. Health professionals' knowledge, attitude and behavior in OA care

    Time frame: Pre- and post-workshop + 6 months post-workshop

  15. Referrals to orthopaedic surgeons

    Number of referrals to secondary care that does not lead to scheduled joint surgery

    Time frame: Up to 1 year

  16. Referrals to MRI

    Number of referrals to MRI for OA assessment

    Time frame: Up to 1 year

  17. Number of referrals to physiotherapy treatment

    Time frame: Up to 1 year

  18. Discharge reports from physiotherapists

    Number of discharge reports from PTs at FLSs/ private practice to the referring GP

    Time frame: Up to 1 year

  19. Arthritis Self-efficacy Scale

    Time frame: 6 months

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Study locations

1 site
  • Diakonhjemmet Hospital
    Oslo, 0319, Norway
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References and documents

Publications

  • Moseng T, Dagfinrud H, van Bodegom-Vos L, Dziedzic K, Hagen KB, Natvig B, Rotterud JH, Vlieland TV, Osteras N. Low adherence to exercise may have influenced the proportion of OMERACT-OARSI responders in an integrated osteoarthritis care model: secondary analyses from a cluster-randomised stepped-wedge trial. BMC Musculoskelet Disord. 2020 Apr 13;21(1):236. doi: 10.1186/s12891-020-03235-z. PubMed 32284049 ↗
  • Osteras N, Moseng T, van Bodegom-Vos L, Dziedzic K, Mdala I, Natvig B, Rotterud JH, Schjervheim UB, Vlieland TV, Andreassen O, Hansen JN, Hagen KB. Implementing a structured model for osteoarthritis care in primary healthcare: A stepped-wedge cluster-randomised trial. PLoS Med. 2019 Oct 15;16(10):e1002949. doi: 10.1371/journal.pmed.1002949. eCollection 2019 Oct. Erratum In: PLoS Med. 2019 Dec 19;16(12):e1002993. doi: 10.1371/journal.pmed.1002993. PubMed 31613885 ↗
  • Moseng T, Dagfinrud H, Osteras N. Implementing international osteoarthritis guidelines in primary care: uptake and fidelity among health professionals and patients. Osteoarthritis Cartilage. 2019 Aug;27(8):1138-1147. doi: 10.1016/j.joca.2019.03.010. Epub 2019 May 8. PubMed 31075423 ↗
  • Osteras N, van Bodegom-Vos L, Dziedzic K, Moseng T, Aas E, Andreassen O, Mdala I, Natvig B, Rotterud JH, Schjervheim UB, Vlieland TV, Hagen KB. Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial. Implement Sci. 2015 Dec 2;10:165. doi: 10.1186/s13012-015-0353-7. PubMed 26631224 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02333656
Lead sponsor
Diakonhjemmet Hospital
Collaborators
The Research Council of Norway
Responsible party
Nina Osteras (Researcher, Diakonhjemmet Hospital) — Principal investigator
First posted
Jan 7, 2015
Start date
Jan 2015
Primary completion
Oct 2017
Completion
Oct 2017
Last update
Feb 1, 2018

Study contacts

Kåre Hagen, Prof.
study director · Project administrator/Research director
Nina Østerås, PhD
principal investigator · Researcher

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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