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

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783848
• Other study ID #: Pro00009919
• Secondary ID: 5U01AR052186-02
• Status: Completed
• Phase: N/A
• First received: October 30, 2008
• Last updated: April 26, 2013
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No