Validation of PROMIS Banks With COPD Exacerbations

NCT00784342 | Completed

• 1 other identifier: 07-02
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• University of Pittsburgh: collaborator
• Duke University: collaborator
• Endeavor Health: collaborator

Study Sites (5)

NorthShore University HealthSystem (Formerly Evanston Northwestern Healthcare)

Evanston, Illinois, 60201, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27701, United States

Location

Pittsburgh VA Hospital

Pittsburgh, Pennsylvania, 15240, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Darren A. Dewalt, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: November 3, 2008
• Study Start: July 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 13, 2012

Record last verified: 2012-12

Locations

US (5)