Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00783848 · ClinicalTrials.gov registry record
Validating PROMIS Instruments in Congestive Heart Failure Patients Receiving a Heart Transplant
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 58
- Enrollment target
NCT00783848: Completed study, sponsored by Duke University.
NCT00783848 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 58 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00783848 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 58 participants
- Enrollment target
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.
Primary Outcome
Clinical and patient-reported assessments will be performed at baseline and 8-12 weeks 86 (end of study). Clinical indicators of functioning will include the New York Heart 87 Association (NYHA) classification and the six-minute walk test. We will include the 88 Kansas City Cardiomyopathy Questionnaire (KCCQ), a disease-specific measure of health-89 related quality of life (HRQOL), as a point of reference for understanding the relative 90 validity (including responsiveness) of the PRPROMIS item
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-12 |
What the finished NCT00783848 record still lists
NCT00783848 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 58 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00783848 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00783848 about?
NCT00783848 is a clinical study titled "Validating PROMIS Instruments in Congestive Heart Failure Patients Receiving a Heart Transplant". 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 ...
What is the current status of trial NCT00783848?
This trial is currently completed. The enrollment target is 58 participants. The study started on 2009-03. Estimated completion is 2010-12.
Who is sponsoring clinical trial NCT00783848?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03587844 · 58 participants · Phase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
- NCT03630991 · 58 participants · Phase 1
Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy
- NCT03949855 · 58 participants · Phase 2
Belimumab With Rituximab for Primary Membranous Nephropathy
- NCT04069273 · 58 participants · Phase 2
Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia