Validation of PROMIS Banks With COPD Exacerbations

This study has been completed.
Sponsor:
Collaborators:
University of Pittsburgh
Duke University
NorthShore University HealthSystem Research Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00784342
First received: October 30, 2008
Last updated: December 12, 2012
Last verified: December 2012

October 30, 2008
December 12, 2012
July 2008
June 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00784342 on ClinicalTrials.gov Archive Site
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Validation of PROMIS Banks With COPD Exacerbations
Validation of PROMIS Banks With COPD Exacerbations

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 of chronic diseases and demographic characteristics. In the first four years of its existence, the PROMIS network developed item banks for measuring patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical function, and social functioning. During the item banking process, the PROMIS network conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses to refine the meaning, clarity, and literacy demands of all items. The item banks were administered to over 20,000 respondents and calibrated using models based on item response theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were developed and implemented. The network has designed a series of studies using clinical populations to evaluate the item attributes, examine their utility as CATs, and validate the item banks. More information on the PROMIS network can be found at www.nihpromis.org.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

People presenting to primary care or specialty clinics with COPD either with exacerbation or without exacerbation. People admitted to the hospital with a COPD exacerbation.

Chronic Obstructive Pulmonary Disease
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  • Stable
    Patients who are stable have not had a COPD exacerbation in the past 2 months.
  • Exacerbation
    Patients with an exacerbation have been diagnosed and started on treatment for an exacerbation within the past 3 days.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
188
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.)
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00784342
07-02
No
University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
  • University of Pittsburgh
  • Duke University
  • NorthShore University HealthSystem Research Institute
Principal Investigator: Darren A. Dewalt, MD, MPH University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP