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Disability and Health Outcomes in COPD

Disability and Health Outcomes in COPD

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00087906
Enrollment
1589
Registered
2004-07-19
Start date
2004-07-31
Completion date
2009-05-31
Last updated
2015-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Lung Diseases

Brief summary

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

Detailed description

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.

Interventions

None listed

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 55 Years
Healthy volunteers
No

Inclusion criteria

Inclusion: 1. COPD diagnosis and 2. Medication use for cases Exclusion: 1\. Withdrew from Kaiser Plan prior to baseline contact

Design outcomes

Primary

MeasureTime frameDescription
COPD Disability10 yearsObservational self-reported impairment in valued life activities.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026