Status:
COMPLETED
Validation of PROMIS Banks With COPD Exacerbations
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
University of Pittsburgh
Duke University
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Brief Summary
The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range...
Detailed Description
This is a prospective longitudinal study of adult patients with chronic obstructive pulmonary disease (COPD) who will be enrolled when their COPD is considered clinically stable or during an acute exa...
Eligibility Criteria
Inclusion
- An established clinical history of COPD in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) definition: COPD is a preventable and treatable disease with some significant extrapulmonary effects that may contribute to the severity in individual patients. Its pulmonary component is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases.
- A history of smoking (at least 10 pack/year history)
- Access to and able to communicate on a touch tone telephone
- Read and speak English
- Able to see and interact with a computer screen, mouse, and keyboard
- A signed and dated written informed consent prior to study participation
- For those enrolled into the exacerbation group: Treatment for an exacerbation may have been started no more than 3 days prior to the day of enrollment for patients recruited in the outpatient setting and no more than 6 days prior to the day of enrollment for patients recruited in the in-patients setting.
- For those enrolled in the stable state group, the patient will be considered stable if he or she has been exacerbation-free for a minimum of 2 months prior to enrollment.
Exclusion
- Any concurrent medical or psychiatric condition that may preclude participation in this study or completion of self-administered questionnaires (e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia, or other condition that would render the participant unable to complete a questionnaire)
- History of asthma without co-existent COPD as the primary diagnosis
- Experiencing a current heart failure exacerbation. (A diagnosis of heart failure is not in itself an exclusion criterion.)
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00784342
Start Date
July 1 2008
End Date
June 1 2009
Last Update
December 13 2012
Active Locations (5)
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1
NorthShore University HealthSystem (Formerly Evanston Northwestern Healthcare)
Evanston, Illinois, United States, 60201
2
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
3
Duke University
Durham, North Carolina, United States, 27701
4
Pittsburgh VA Hospital
Pittsburgh, Pennsylvania, United States, 15240