Disability and Health Outcomes in COPD
| Tracking Information | |||||
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| First Received Date ICMJE | July 15, 2004 | ||||
| Last Updated Date | March 27, 2013 | ||||
| Start Date ICMJE | July 2004 | ||||
| Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00087906 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Disability and Health Outcomes in COPD | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | To test a conceptual model of how disability develops in chronic obstructive pulmonary disease (COPD). |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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). |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1589 | ||||
| Completion Date | May 2009 | ||||
| Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00087906 | ||||
| Other Study ID Numbers ICMJE | 1262, R01HL077618 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | University of California, San Francisco | ||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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