Validating PROMIS Instruments in Congestive Heart Failure Patients Receiving a Heart Transplant
Completed
Conditions studied: Congestive Heart Failure
In brief
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.
Key facts
- Study ID
- NCT00783848
- Run by
- Duke University
- People needed
- 58
- Starts
- 2009-03-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2013-04-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Heart failure had to represent the greatest medical limitation on daily function for the patient in the judgment of the attending cardiologist
- Ability to read, write, and speak in English
- Ability to understand and provide informed consent
- Placement on heart transplant registry (awaiting heart transplant surgery)
You may not qualify if…
- Current diagnosis of psychosis or dementia
Where it is running
- Stanford University — Palo Alto, California, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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