Disability and Health Outcomes in COPD
|ClinicalTrials.gov Identifier: NCT00087906|
Recruitment Status : Completed
First Posted : July 19, 2004
Last Update Posted : December 24, 2015
|Condition or disease|
|Chronic Obstructive Pulmonary Disease Lung Diseases|
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||1589 participants|
|Observational Model:||Case Control|
|Official Title:||Disability and Health Outcomes in COPD|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
- COPD Disability [ Time Frame: 10 years ]Observational self-reported impairment in valued life activities.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00087906
|Principal Investigator:||Paul Blanc, MD||University of California at San Francisco|