ClinicalTrials.gg
CompletedNCT03102788Updated Jul 12, 2024

Task Shifting in the Care for Patients With Hand Osteoarthritis

An interventional study of Rheumatologist-led care. and Occupational therapist-led care. in Osteoarthritis Both Hands, sponsored by National Resource Center for Rehabilitation in Rheumatology. Completed at 3 sites in Norway. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by National Resource Center for Rehabilitation in Rheumatology · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

The main aim in this randomized controlled trial is to improve access to safe and effective care, professional practice and cost-effective utilisation of health care resources by testing if occupational therapist-led care is as effective and safe as rheumatologist-led care for people with hand osteoarthritis.

Read the detailed description

Hand osteoarthritis is one of the most prevalent musculoskeletal conditions in an adult population, and may have large influences on an individual's function, health related quality of life, and participation in the society. In the absence of disease-modifying interventions, occupational therapy, comprising information, hand exercises, assistive devices and orthoses/splints, is considered as core treatment. In Norway, people with hand osteoarthritis are increasingly referred to consultation by a rheumatologist in specialist health care. At the same time a shortage of rheumatologists nationwide is stressing the healthcare system's capacity, and rheumatologists time should therefore primarily be allocated to patients in which early diagnosis and medical treatment are essential.

The World Health Organization recommend task-shifting as one method of strengthening and expanding the health workforce. Such models rely on other healthcare providers in expanded clinical roles, where physiotherapists, nurses or occupational therapists working in collaboration with physicians and other team members have their own patients for whom they provide health care services.

In this randomized controlled trial, we will test if a new model, where patients referred to consultation in specialist health care receive their first consultation by an occupational therapy specialist, is as safe and effective as the traditional model, where they receive their first consultation by a rheumatologist.

02

Conditions studied

  • Osteoarthritis Both Hands
03

In context

Lead sponsor

National Resource Center for Rehabilitation in Rheumatology is the lead sponsor of 5 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hand osteoarthritis diagnosed by physician in primary care, referred for consultation in specialist health care, and ability to communicate in Norwegian.

Exclusion criteria

Exclusion Criteria:

  • Exclusion criteria were cognitive or mental impairment, possible inflammatory rheumatic disease (SR>40 or CRP>20, or patient confirming having psoriasis during telephone screening).
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
400 participants (actual)

Study arms

  • Active comparator
    Control

    Patients in the control group will receive their first consultation in specialist health care by a rheumatologist. Rheumatologist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, and, for some patients, Intra-articular injection of long-acting Corticosteroid. The rheumatologist may also refer participants to occupational therapy if needed.

    Behavioral: Rheumatologist-led care.

  • Experimental
    Intervention

    Patients in the intervention group will receive their first consultation in specialist health care by an occupational therapy specialist. Occupational therapist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, teaching of hand exercises and ergonomic working methods, and, for some patients, provision assistive devices and orthoses/splints. The occupational therapist will refer patients to a short rheumatologist consultation if confirmation of diagnosis or intra-articular injections of long-acting Corticosteroid are needed.

    Behavioral: Occupational therapist-led care.

Interventions

  • BehavioralRheumatologist-led care.

    Rheumatologist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, and, for some patients, Intra-articular injection of long-acting Corticosteroid. The rheumatologist may also refer participants to occupational therapy if needed.

  • BehavioralOccupational therapist-led care.

    Occupational therapist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, teaching of hand exercises and ergonomic working methods, and, for some patients, provision assistive devices and orthoses/splints. The occupational therapist will refer patients to a short rheumatologist consultation if confirmation of diagnosis or intra-articular injections of long-acting Corticosteroid are needed.

06

What researchers measure

Primary outcomes

  1. Number of treatment responders

    Number of treatment responders will be calculated as number of OMERACT/OARSI-responders. This is a composite index that presents the results of changes after treatment in the three domains of pain, function and patient's global assessment as a single variable (responder yes/no).

    Time frame: One year

Secondary outcomes

  1. Number of painful finger joints

    Joint count of number of painful finger joints at each hand

    Time frame: One year

  2. Hand pain measured on a numeric rating scale

    Hand pain will be measured on a numeric rating scale

    Time frame: One year

  3. Hand stiffness measured on a numeric rating scale

    Hand stiffness will be measured on a numeric rating scale

    Time frame: One year

  4. Disease activity measured on a numeric rating scale

    Disease activity will be measured on a numeric rating scale

    Time frame: One year

  5. Physical function measured by the Functional Index for Hand OsteoArthritis

    Physical function will be measured by the Functional Index for Hand OsteoArthritis

    Time frame: One year

  6. Activity performance measured by the Measure of Activity Performance of the Hand

    Activity performance will be measured by the Measure of Activity Performance of the Hand

    Time frame: One year

  7. Grip strength measured by JAMAR dynamometer

    Grip strength will be measured by JAMAR dynamometer

    Time frame: One year

  8. Health related quality of life measured by EQ5D

    Health related quality of life will be measured by EQ5D

    Time frame: One year

  9. Satisfaction with care measured by PASS-Opp

    Satisfaction with care will be measured by PASS-Opp

    Time frame: One year

07

Study locations

3 sites
  • Diakonhjemmet Hospital
    Oslo, 0319, Norway
  • National resource center for rehabilitation in rheumatology
    Oslo, 0319, Norway
  • Martina Hansens Hospital
    Sandvika, 1306, Norway
08

References and documents

Publications

  • Polster A, Olsen U, Asphaug L, Bergsmark K, Christensen B, Haugen IK, Hennig T, Hermann-Eriksen M, Hove A, Sjovold T, Sexton J, Tveter AT, Kjeken I. Occupational therapist-led versus rheumatologist-led care in people with hand osteoarthritis in Norway: an open-label, multicentre, randomised controlled, non-inferiority trial. Lancet Rheumatol. 2025 Aug;7(8):e533-e543. doi: 10.1016/S2665-9913(25)00040-2. Epub 2025 Jun 10. PubMed 40513596 ↗
  • Kjeken I, Bergsmark K, Haugen IK, Hennig T, Hermann-Eriksen M, Hornburg VT, Hove A, Proven A, Sjovold TA, Slatkowsky-Christensen B. Task shifting in the care for patients with hand osteoarthritis. Protocol for a randomized controlled non-inferiority trial. BMC Musculoskelet Disord. 2021 Feb 16;22(1):194. doi: 10.1186/s12891-021-04019-9. PubMed 33593307 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03102788
Lead sponsor
National Resource Center for Rehabilitation in Rheumatology
Collaborators
Diakonhjemmet Hospital, Martina Hansen Hospital
Responsible party
Ingvild Kjeken (Professor, National Resource Center for Rehabilitation in Rheumatology) — Principal investigator
First posted
Apr 6, 2017
Start date
Sep 14, 2017
Primary completion
Nov 14, 2020
Completion
Nov 14, 2020
Last update
Jul 12, 2024

Study contacts

Tore K Kvien, PhD
study director · Research director, Diakohjemmet Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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