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| Name | Class |
|---|---|
| Diakonhjemmet Hospital | OTHER |
| Martina Hansen Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of painful finger joints | Joint count of number of painful finger joints at each hand | One year |
| Hand pain measured on a numeric rating scale | Hand pain will be measured on a numeric rating scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tore K Kvien, PhD | Research director, Diakohjemmet Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diakonhjemmet Hospital | Oslo | 0319 | Norway | |||
| National resource center for rehabilitation in rheumatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40513596 | Derived | 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. | |
| 33593307 |
| Label | URL |
|---|---|
| Published study protocol | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 19, 2024 | Jul 11, 2024 | SAP_001.pdf |
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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.
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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.
|
| 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. |
|
| One year |
| Hand stiffness measured on a numeric rating scale | Hand stiffness will be measured on a numeric rating scale | One year |
| Disease activity measured on a numeric rating scale | Disease activity will be measured on a numeric rating scale | One year |
| Physical function measured by the Functional Index for Hand OsteoArthritis | Physical function will be measured by the Functional Index for Hand OsteoArthritis | One year |
| 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 | One year |
| Grip strength measured by JAMAR dynamometer | Grip strength will be measured by JAMAR dynamometer | One year |
| Health related quality of life measured by EQ5D | Health related quality of life will be measured by EQ5D | One year |
| Satisfaction with care measured by PASS-Opp | Satisfaction with care will be measured by PASS-Opp | One year |
| Oslo |
| 0319 |
| Norway |
| Martina Hansens Hospital | Sandvika | 1306 | Norway |
| 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. |