AzTrials
AzTrials

Hip OsteoarthritisNCT02333656

Management of Hip and Knee Osteoarthritis in Primary Health Care

A study testing New OA model in people with Hip Osteoarthritis and Knee Osteoarthritis, run by Diakonhjemmet Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Hip Osteoarthritis, Knee Osteoarthritis
What is being tested?
New OA model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
393 participants
Where
1 siteNorway
Study dates
Jan 2015to Oct 2017
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Diakonhjemmet Hospital

    Oslo, 0319

Other trials in Norway

About this study

Official title: Improved Management of Patients With Hip and Knee Osteoarthritis in Primary Health Care

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.

Being tested
New OA model
Medical subject headings
Osteoarthritis, Hip, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • New OA modelOther

    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.

Study groups in NCT02333656
Study groupRoleWhat they receive
Control groupNo interventionUsual care. The participants enrolled in the control period will receive OA treatment as it is currently offered in primary health care services.
Intervention groupExperimentalNew OA model. Health professionals attend an interactive workshop, implementation of international recommendations for OA care, multidiciplinary collaboration
Receives: Other: New OA model

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Osteoarthritis Quality Indicator questionnaire

    Patient reported achievement of quality indicators for osteoarthritis care

    Measured: 6 months

Secondary outcomes (19)

  1. Pain

    Pain level in hip/knee past week

    Measured: 6 months

  2. Joint stiffness

    Stiffness in the hip/knee past week

    Measured: 6 months

  3. Global function

    Hip/knee function in the past week

    Measured: 6 months

  4. Patient global assessment of the OA disease

    Measured: 6 months

  5. Patient Acceptable Symptom State (PASS)

    Measured: 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)

    Measured: 6 months

  7. Physical activity level

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

    Measured: 6 months

  8. Daily sitting

    Daily hours in sitting position

    Measured: 6 months

  9. Satisfaction with the care provided

    Measured: 6 months

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

    Measured: 6 months

  11. Self-reported body weight

    Measured: 6 months

  12. Health care use, medication use and sick leave

    Measured: 6 months

  13. Adverse events

    Measured: Up to 1 year

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

    Measured: 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

    Measured: Up to 1 year

  16. Referrals to MRI

    Number of referrals to MRI for OA assessment

    Measured: Up to 1 year

  17. Number of referrals to physiotherapy treatment

    Measured: Up to 1 year

  18. Discharge reports from physiotherapists

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

    Measured: Up to 1 year

  19. Arthritis Self-efficacy Scale

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionOct 2017
  4. Study completionOct 2017

Resources

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
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
393 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02333656
Sponsor's protocol ID
229079
Status last verified
Jan 2018
First submitted
4 Jan 2015
Last updated
1 Feb 2018
Results posted
No
Data monitoring committee
No

Publications

  • Osteras N, Aas E, Moseng T, van Bodegom-Vos L, Dziedzic K, Natvig B, Rotterud JH, Vlieland TV, Furnes O, Fenstad AM, Hagen KB. Longer-term quality of care, effectiveness, and cost-effectiveness of implementing a model of care for osteoarthritis: A cluster-randomized controlled trial. Osteoarthritis Cartilage. 2024 Jan;32(1):108-119. doi: 10.1016/j.joca.2023.10.003. Epub 2023 Oct 13.

    PubMed 37839506

  • 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.

    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

Questions about this trial

What is this clinical trial studying?

A study testing New OA model in people with Hip Osteoarthritis and Knee Osteoarthritis, 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 2 inclusion and 4 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 1 Feb 2018. 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?

Osteoarthritis Quality Indicator questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02333656, which also lists 5 linked publications.

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 1 Feb 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in