Mechanical Support Measures of Adjustment and QOL

Completed

• Conditions: Heart Failure; Quality of Life; Cardiovascular Diseases

• Registration Number: NCT03044535
• Lead Sponsor: Northwestern University

Brief Summary

The purpose of this study is to develop a measurement system to assess adjustment to mechanical circulatory support (MCS) (also referred to as a ventricular assist device \[VAD\]) and health-related quality of life (HRQOL) in patients with advanced heart failure who receive a VAD. This investigators refer to this measurement system as Mechanical Circulatory Support: Adjustment and Quality of Life (MCS A-QOL).

Detailed Description

It is estimated that 5.1 million U.S. adults have heart failure, with an incidence of 825,000 new cases annually. The prevalence of heart failure is expected to increase by 46% from 2012 to 2030. Mechanical circulatory support (MCS) has been developed as a bridge to heart transplantation and as permanent support (i.e., destination therapy). MCS devices help the heart pump blood to the body. Left ventricular assist devices (LVADs), a type of MCS, support the left heart.

Health-related quality of life (HRQOL) is a very important outcome that advanced heart failure patients care about when making health care decisions, including when considering surgical treatment options, such as heart transplantation and mechanical circulatory support.

Currently available HRQOL questionnaires do not assess the unique burdens of MCS, such as changing power sources and driveline exit site dressings; safety precautions (e.g., no immersion in water, need for an MCS-trained caregiver); troubleshooting VAD alarms; and MCS-specific complications, often associated with frequent hospitalizations. Since these questionnaires do not focus on issues of concern to MCS patients, they lack sensitivity and precision to measure the potentially wide-ranging impact of MCS on HRQOL.

Guided by the investigators empirically supported MCS A-QOL conceptual model, the investigators will use state-of-the-science psychometric measurement methods to create "item banks" (sets of items that comprise carefully calibrated questions which define and quantify a common theme) from the investigators existing MCS A-QOL item pools (library of relevant items). Using calibrated item banks, the investigators will develop computer adaptive tests (CATs) and fixed-length short forms to reduce respondent burden and enhance measurement precision. The investigators will assess reliability, validity, responsiveness to change, and clinically important differences of MCS A-QOL measures.

Study Timeline

• Study Start: 2016-10-26
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-07
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 895

Inclusion Criteria

1. Patient with a continuous flow MCS device left (L)VAD who is more than 3 months post-implant at the following intervals: 3, 6, 12, 18, 24, 30, 36, 42, 48 months and every 6 months thereafter. Note: patients can have had prior MCS devices.
2. The continuous flow MCS device, implant strategy can be a bridge to transplant, destination therapy, or bridge to recovery
3. Age >= 19 years and able to speak and understand English
4. Sufficient cognitive ability to provide self-report data on a computer touchscreen/standard computer and/or on paper-based forms with minimal assistance
5. Willing to participate and able to give written informed consent

Group 2

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Exclusion Criteria

1. Has a bi-VAD, right (R)VAD, or total artificial heart

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Creation of new MCS A-QOL item banks and short forms and validation of existing instruments	Longitudinally: baseline through 6 months post-MCS implant and cross-sectionally through 10 years post-MCS implant	Psychometric measurement methods will be used to create new "item banks" (sets of items that comprise carefully calibrated questions which define and quantify a common theme) and short forms from our existing MCS A-QOL item pools (library of relevant items). Psychometric properties (e.g., reliability, validity, etc) of these new measures and existing instruments, some of them modified, will be evaluated, in order to provide evidence of their clinical utility for measuring adjustment to MCS and HRQOL.

Trial Locations

Locations (12)

University of California, San Diego; 🇺🇸 La Jolla, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

St. Vincent Hospital; 🇺🇸 Indianapolis, Indiana, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Integris Health; 🇺🇸 Oklahoma City, Oklahoma, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University of California; 🇺🇸 San Francisco, California, United States

University of Colorado; 🇺🇸 Denver, Colorado, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States