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Disability and Health Outcomes in COPD

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ClinicalTrials.gov Identifier: NCT00087906
Recruitment Status : Completed
First Posted : July 19, 2004
Last Update Posted : December 24, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To test a conceptual model of how disability develops in chronic obstructive pulmonary disease (COPD).

Condition or disease
Chronic Obstructive Pulmonary Disease Lung Diseases

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.


Study Design

Study Type : Observational
Actual Enrollment : 1589 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Disability and Health Outcomes in COPD
Study Start Date : July 2004
Primary Completion Date : May 2009
Study Completion Date : May 2009
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. COPD Disability [ Time Frame: 10 years ]
    Observational self-reported impairment in valued life activities.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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).
Criteria

Inclusion:

  1. COPD diagnosis and
  2. Medication use for cases

Exclusion:

1. Withdrew from Kaiser Plan prior to baseline contact

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00087906


Sponsors and Collaborators
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Paul Blanc, MD University of California at San Francisco
More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00087906     History of Changes
Other Study ID Numbers: 1262
R01HL077618 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2004    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases