Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087906
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2004-07-15
Brief Title:
Disability and Health Outcomes in COPD
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Disability and Health Outcomes in COPD
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg pulmonary function and functional limitation eg 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
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 eg pulmonary function and functional limitation eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL077618 | NIH | None | httpsreporternihgovquickSearchR01HL077618 |