Task Shifting in the Care for Patients With Hand Osteoarthritis

NCT03102788 | Completed

• 1 other identifier: Project nr 97001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Osteoarthritis Both Hands

Outcome Measures

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).

  One year

Secondary Outcomes (9)

• Number of painful finger joints

  One year

• Hand pain measured on a numeric rating scale

  One year

• Hand stiffness measured on a numeric rating scale

  One year

• Disease activity measured on a numeric rating scale

  One year

• Physical function measured by the Functional Index for Hand OsteoArthritis

  One year

Study Arms (2)

Control

ACTIVE COMPARATOR

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.

Intervention

EXPERIMENTAL

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

Rheumatologist-led care. BEHAVIORAL

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.

Control

Occupational therapist-led care. BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• National Resource Center for Rehabilitation in Rheumatology: lead
• Diakonhjemmet Hospital: collaborator
• Martina Hansen Hospital: collaborator

Study Sites (3)

Diakonhjemmet Hospital

Oslo, 0319, Norway

Location

National resource center for rehabilitation in rheumatology

Oslo, 0319, Norway

Location

Martina Hansens Hospital

Sandvika, 1306, Norway

Location

Related Publications (2)

• 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.

  PMID: 40513596 DERIVED

• 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.

  PMID: 33593307 DERIVED

Related Links

• Published study protocol

Study Officials

• Tore K Kvien, PhD

  Research director, Diakohjemmet Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research assistant who will examine the participants at baseline and follow-ups and the statistician who perform the main effect analysis will be blinded for group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: In this randomized controlled trial, participants will be allocated to receive their first consultation in specialist health care by either an occupational therapy specialist or a rheumatologist. The occupational therapist may thereafter refer the patient to a consultation with a rheumatologist if necessary, and vice versa.

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 6, 2017
• Study Start: September 14, 2017
• Primary Completion: November 14, 2020
• Study Completion: November 14, 2020
• Last Updated: July 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)