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
  Purpose

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.


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of PROMIS Banks With COPD Exacerbations

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Enrollment: 188
Study Start Date: July 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784342

Locations
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
Duke University
Durham, North Carolina, United States, 27701
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Pittsburgh VA Hospital
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
University of North Carolina, Chapel Hill
University of Pittsburgh
Duke University
NorthShore University HealthSystem Research Institute
Investigators
Principal Investigator: Darren A. Dewalt, MD, MPH University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00784342     History of Changes
Other Study ID Numbers: 07-02
Study First Received: October 30, 2008
Last Updated: December 12, 2012
Health Authority: United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014