Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
National Institutes of Health (NIH) Stanford University University of Pittsburgh |
---|---|
Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00783848 |
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.
Condition |
---|
Congestive Heart Failure |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Validating PROMIS Instruments in Congestive Heart Failure Patients Receiving a Heart Transplant |
Estimated Enrollment: | 150 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
This project will assess the validity (including responsiveness) of selected Patient Reported Outcome Measurement Information System (PROMIS) instruments in patients with severe CHF who receive heart transplants. The following is a list of goals for this project:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Participants will be recruited through heart transplant program registries and in consultation with practicing cardiologists at Duke University, Stanford University, and the University of Pittsburgh.
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Stanford University | |
Palo Alto, California, United States, 94305 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27708 | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Kevin Weinfurt, PhD | Duke University |
Responsible Party: | Duke University ( Kevin P. Weinfurt, PhD ) |
Study ID Numbers: | 07-03 |
Study First Received: | October 30, 2008 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00783848 |
Health Authority: | United States: Federal Government |
CHF |
Heart Failure Heart Diseases |
Cardiovascular Diseases |