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Disability and Health Outcomes in COPD

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00087906
First received: July 15, 2004
Last updated: December 22, 2015
Last verified: December 2015

July 15, 2004
December 22, 2015
July 2004
May 2009   (final data collection date for primary outcome measure)
COPD Disability [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Observational self-reported impairment in valued life activities.
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Complete list of historical versions of study NCT00087906 on ClinicalTrials.gov Archive Site
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Disability and Health Outcomes in COPD
Disability and Health Outcomes in COPD
To test a conceptual model of how disability develops in chronic obstructive pulmonary disease (COPD).

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample
We recruited persons with COPD for what we came to term the "FLOW study." The original project was funded to complete two interviews and a single research clinic evaluation. In addition to completing this original program of work successfully, we also carried out follow-up research clinic visits for 667 subjects. These supplemental examinations were made possible through research funding support from the Flight Attendants Medical Research Foundation (FAMRI).
  • Chronic Obstructive Pulmonary Disease
  • Lung Diseases
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1589
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion:

  1. COPD diagnosis and
  2. Medication use for cases

Exclusion:

1. Withdrew from Kaiser Plan prior to baseline contact

Both
up to 55 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00087906
1262, R01HL077618
No
No
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University of California, San Francisco
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Paul Blanc, MD University of California at San Francisco
University of California, San Francisco
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP