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临床试验/NCT00128765
NCT00128765已完成不适用

Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease (COPD) in General Practice. A Randomized Controlled Trial Comparing Regular Practice Nurse Review, Self-management Education and Usual Care

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2005年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
165
试验地点
2
主要终点
disease-specific health-related quality of life (HRQoL)

研究概览

简要总结

In this randomized controlled trial, three contemporary modes for chronic obstructive pulmonary disease (COPD) management in Dutch general practices are compared for costs and effects:

  • usual general practitioner (GP) care (at patient's initiative);
  • regular practice nurse review; and
  • integrated self-management education.

All three interventions are based on existing guidelines, materials, and field experiences.

详细描述

Considering the ageing of the Dutch population and the current and increasing shortage of general practitioners (GPs), the capacity of primary healthcare is a major and growing concern. Delegation of care normally provided by GPs with care provided by trained practice nurses is now rapidly emerging for patients with chronic respiratory disease, i.e. asthma and chronic obstructive pulmonary disease (COPD). However, most general practices still provide care at initiative of the patient self, because of the lack in scientific evidence and the costs of implementing a regular care structure. Self-care by patients may be an alternative to alleviate the growing load on primary health care.

The following two main research questions are addressed in this study.

  • Does an integrated self-management education intervention for patients with COPD in general practice contribute to attaining long-term treatment targets, compared to regular monitoring by a practice nurse and usual GP care?
  • What is the cost-effectiveness of an integrated self-management education intervention for patients with COPD, compared to regular monitoring by a practice nurse and usual GP care?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Registered in one of the general practices participating in the study
  • Diagnosis of COPD, with Global Initiative for Chronic Obstructive Lung Diseases (GOLD) stage I, II or III
  • Age ≥35 years
  • Willing to provide written informed consent

排除标准

  • Very poor prognosis with regard to respiratory condition (GOLD stage IV)
  • Severe co-morbid conditions with a reduced life expectancy
  • Unable to communicate in the Dutch language
  • Objections to one or more of the disease management modes in the study

结局指标

主要结局

disease-specific health-related quality of life (HRQoL)

时间窗: two years

次要结局

  • the number of exacerbations(two years)
  • generic quality of life(two years)
  • decline post- and pre-bronchodilator (BD) lung function indices(two years)
  • level of respiratory symptoms(two years)
  • satisfaction with the health care received(two years)
  • compliance with (non-) pharmaceutical treatment(two years)
  • direct and indirect medical costs(two years)
  • COPD related self-efficacy(two years)
  • COPD coping styles(two years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

E. Bischoff

MD MSc

Radboud University Medical Center

研究点 (2)

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