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

NCT00783848 | Completed

• 2 other identifiers: Pro000099195U01AR052186-02
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Congestive Heart Failure

Keywords

CHF

Outcome Measures

Primary Outcomes (1)

• Evaluate the validity (including responsiveness) of selected PROMIS domains for patients with severe heart failure who receive a heart 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).

  baseline and 8-12 weeks post-transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• University of Pittsburgh: collaborator

Study Sites (2)

Stanford University

Palo Alto, California, 94305, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Kevin Weinfurt, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: November 3, 2008
• Study Start: March 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

US (2)