Validation of PROMIS Banks With COPD Exacerbations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00784342|
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : December 13, 2012
|Condition or disease|
|Chronic Obstructive Pulmonary Disease|
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 exacerbation. This design will allow both within-person and between-person comparisons by exacerbation experience. Comprehensive clinical and patient-reported assessments will be performed at baseline and at 3 months (end of study). Subsets of items will be administered by interactive voice response (IVR) over the course of the study to measure changes in key symptoms over the course of recovery from an exacerbation. A subset of patients will be interviewed at the end of the study to assess content validity of PROMIS items in this patient population.
With such a study design, we will be able to evaluate the validity of the PROMIS items in this patient population under acute and stable conditions and evaluate responsiveness of several PROMIS item banks under conditions of known change in an underlying chronic disease. We will also evaluate stability of sub-domains that are not hypothesized to change with COPD exacerbations.
|Study Type :||Observational|
|Actual Enrollment :||188 participants|
|Official Title:||Validation of PROMIS Banks With COPD Exacerbations|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
Patients who are stable have not had a COPD exacerbation in the past 2 months.
Patients with an exacerbation have been diagnosed and started on treatment for an exacerbation within the past 3 days.
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): NCT00784342
|United States, Illinois|
|NorthShore University HealthSystem (Formerly Evanston Northwestern Healthcare)|
|Evanston, Illinois, United States, 60201|
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Durham, North Carolina, United States, 27701|
|United States, Pennsylvania|
|Pittsburgh VA Hospital|
|Pittsburgh, Pennsylvania, United States, 15240|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15261|
|Principal Investigator:||Darren A. Dewalt, MD, MPH||University of North Carolina, Chapel Hill|