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Validating PROMIS Instruments in Congestive Heart Failure Patients Receiving a Heart Transplant
This study is not yet open for participant recruitment.
Verified by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), November 2008
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
  Purpose

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

MedlinePlus related topics: Heart Failure Heart Transplantation
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Validating PROMIS Instruments in Congestive Heart Failure Patients Receiving a Heart Transplant

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Biospecimen Retention:   None Retained

Biospecimen Description:

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)
Detailed Description:

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:

  • To estimate the responsiveness of PROMIS domain scores by comparing scores in patients with severe heart failure before and after a clinically significant event (heart transplant). The specific PROMIS domains assessed are physical functioning, fatigue, satisfaction with discretionary social activities, depression, and global health.
  • To estimate the responsiveness of a disease-specific patient-reported outcome (PRO) measure, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short Form-36 Vitality subscale (SF-36v2), and the Patient Health Questionnaire (PHQ-2).
  • To collect cross-sectional and longitudinal data on traditional clinical measures of heart failure outcome (6-minute walk test and New York Heart Association [NYHA] class) that can inform the definition of a minimally important difference (MID) for the PROMIS domains of physical functioning, fatigue, satisfaction with discretionary social activities, depression, and global health.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Current diagnosis of psychosis or dementia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783848

Locations
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
Sponsors and Collaborators
Stanford University
University of Pittsburgh
Investigators
Principal Investigator: Kevin Weinfurt, PhD Duke University
  More Information

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

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
CHF

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009