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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03102788
Other study ID # Project nr 97001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2017
Est. completion date November 14, 2020

Study information

Verified date March 2023
Source National Resource Center for Rehabilitation in Rheumatology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date November 14, 2020
Est. primary completion date November 14, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 were cognitive or mental impairment, possible inflammatory rheumatic disease (SR>40 or CRP>20, or patient confirming having psoriasis during telephone screening).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Rheumatologist-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.
Occupational 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.

Locations

Country Name City State
Norway Diakonhjemmet Hospital Oslo
Norway National resource center for rehabilitation in rheumatology Oslo
Norway Martina Hansens Hospital Sandvika

Sponsors (3)

Lead Sponsor Collaborator
National Resource Center for Rehabilitation in Rheumatology Diakonhjemmet Hospital, Martina Hansen Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of painful finger joints Joint count of number of painful finger joints at each hand One year
Secondary Hand pain measured on a numeric rating scale Hand pain will be measured on a numeric rating scale One year
Secondary Hand stiffness measured on a numeric rating scale Hand stiffness will be measured on a numeric rating scale One year
Secondary Disease activity measured on a numeric rating scale Disease activity will be measured on a numeric rating scale One year
Secondary Physical function measured by the Functional Index for Hand OsteoArthritis Physical function will be measured by the Functional Index for Hand OsteoArthritis One year
Secondary 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
Secondary Grip strength measured by JAMAR dynamometer Grip strength will be measured by JAMAR dynamometer One year
Secondary Health related quality of life measured by EQ5D Health related quality of life will be measured by EQ5D One year
Secondary Satisfaction with care measured by PASS-Opp Satisfaction with care will be measured by PASS-Opp One year
See also
  Status Clinical Trial Phase
Completed NCT05041231 - Effects of Using Custom Photobiomodulation Therapy for the Treatment of Osteoarthritis of the Fingers and Rhizarthrosis N/A

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