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临床试验/NCT03102788
NCT03102788已完成不适用

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?

National Resource Center for Rehabilitation in Rheumatology6 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年9月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
6
主要终点
Number of treatment responders

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Number of treatment responders

时间窗: 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).

次要结局

  • Hand stiffness measured on a numeric rating scale(One year)
  • Disease activity measured on a numeric rating scale(One year)
  • Health related quality of life measured by EQ5D(One year)
  • Grip strength measured by JAMAR dynamometer(One year)
  • Number of painful finger joints(One year)
  • Hand pain measured on a numeric rating scale(One year)
  • Physical function measured by the Functional Index for Hand OsteoArthritis(One year)
  • Activity performance measured by the Measure of Activity Performance of the Hand(One year)
  • Satisfaction with care measured by PASS-Opp(One year)

研究者

发起方
National Resource Center for Rehabilitation in Rheumatology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ingvild Kjeken

Professor

National Resource Center for Rehabilitation in Rheumatology

研究点 (6)

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