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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00783848
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : April 29, 2013
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Congestive Heart Failure

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.

Study Design

Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validating PROMIS Instruments in Congestive Heart Failure Patients Receiving a Heart Transplant
Study Start Date : March 2009
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Evaluate the validity (including responsiveness) of selected PROMIS domains for patients with severe heart failure who receive a heart transplant. [ Time Frame: baseline and 8-12 weeks post-transplant ]
    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 banks. Instruments will include 91 PROMIS computerized adaptive tests (CATS).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783848

United States, California
Stanford University
Palo Alto, California, United States, 94305
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Duke University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Pittsburgh
Principal Investigator: Kevin Weinfurt, PhD Duke University
More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00783848     History of Changes
Other Study ID Numbers: Pro00009919
5U01AR052186-02 ( U.S. NIH Grant/Contract )
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: April 29, 2013
Last Verified: April 2013

Keywords provided by Duke University:

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases