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临床试验/NCT00087906
NCT00087906已完成不适用

Disability and Health Outcomes in COPD

University of California, San Francisco0 个研究点目标入组 1,589 人开始时间: 2004年7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
1,589
主要终点
COPD Disability

研究概览

简要总结

To test a conceptual model of how disability develops in chronic obstructive pulmonary disease (COPD).

详细描述

BACKGROUND:

Background. COPD is a common chronic health condition. Because current medical treatments have minimal impact on disease progression, a strategy to prevent COPD-related disability would have important clinical and public health benefits.

DESIGN NARRATIVE:

The study will test a specific conceptual model of how disability develops in COPD. The aims are: (1) To evaluate the impact of respiratory impairment, especially pulmonary function impairment, on the risk of functional limitation in COPD. Using a control group, to elucidate the prevalence of respiratory impairment, functional limitation, and disability that is directly attributable to COPD. (2) In adults with COPD, to delineate the longitudinal effect of functional limitation on the risk of incident disability. The investigators hypothesize that development of functional limitation, and not pulmonary function impairment, is the major determinant of disability. (3) To determine the prospective impact of disability on the risk of future adverse health outcomes. The investigators will assemble a prospective cohort of 1200 randomly sampled adults with COPD who are members of a large regional health maintenance organization. A matched control group of 300 subjects will be recruited. Subjects will undergo a detailed physical assessment that measures respiratory impairment (e.g., pulmonary function) and functional limitation (e.g., lower extremity function, muscle strength, exercise performance, and cognitive function). Structured telephone interviews will ascertain disability outcomes at baseline and 18-month prospective follow-up. The investigators will also study the modulating effects of specific risk factors and protective factors on the progression from functional limitation to COPD-related disability, including psychological factors, environmental exposures, and health care process factors.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

COPD Disability

时间窗: 10 years

Observational self-reported impairment in valued life activities.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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