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Completed

NCT Number: NCT03102788

Task Shifting in the Care for Patients With Hand Osteoarthritis

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diakonhjemmet Hospital, Oslo, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of treatment responders

    Time frame: One year

    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).

Secondary outcomes

  1. Number of painful finger joints

    Time frame: One year

    Joint count of number of painful finger joints at each hand

  2. Hand pain measured on a numeric rating scale

    Time frame: One year

    Hand pain will be measured on a numeric rating scale

  3. Hand stiffness measured on a numeric rating scale

    Time frame: One year

    Hand stiffness will be measured on a numeric rating scale

  4. Disease activity measured on a numeric rating scale

    Time frame: One year

    Disease activity will be measured on a numeric rating scale

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

    Time frame: One year

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

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

    Time frame: One year

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

  7. Grip strength measured by JAMAR dynamometer

    Time frame: One year

    Grip strength will be measured by JAMAR dynamometer

  8. Health related quality of life measured by EQ5D

    Time frame: One year

    Health related quality of life will be measured by EQ5D

  9. Satisfaction with care measured by PASS-Opp

    Time frame: One year

    Satisfaction with care will be measured by PASS-Opp

Sponsors and collaborators

Lead sponsor

National Resource Center for Rehabilitation in Rheumatology

Other

Collaborators

  • Diakonhjemmet Hospital
  • Martina Hansen Hospital

Registry information

Official study title

Task Shifting in the Care for Patients With Hand Osteoarthritis: May the First Consultation in Specialist Health Care be Performed by an Occupational Therapy Specialist?

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 6, 2017
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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