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Validating PROMIS Instruments in Congestive Heart Failure Patients Receiving a Heart Transplant

NCT00783848 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2013-04-29

No results posted yet for this study

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.

The purpose of this research study is to learn about the experience and impact of having congestive heart failure (CHF). In particular, we hope to develop better questionnaires that can measure heart failure patients' quality-of-life.

Conditions

  • Congestive Heart Failure

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • University of Pittsburgh

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Kevin Weinfurt, PhD · Duke University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00783848 on ClinicalTrials.gov