Mechanical Support Measures of Adjustment and QOL

Heart Failure Clinical Trial

— MCS A-QOL  

Official title:

Mechanical Circulatory Support: Measures of Adjustment and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044535
• Other study ID #: STU00201984
• Secondary ID: 1R01HL130502-01
• Status: Completed
• Start date: October 26, 2016
• Est. completion date: February 28, 2020

Study information

• Verified date: February 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 895
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Group 1 Inclusion Criteria

1. Advanced heart failure patients accepted for, or scheduled for, primary (first time) implant of a continuous flow MCS device left (L)VAD

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 1 Exclusion Criteria:

1. Scheduled for implant of a bi-VAD, right (R)VAD, or total artificial heart

Group 2 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 Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Failure
• Quality of Life

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Colorado	Denver	Colorado
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	University of California, San Diego	La Jolla	California
United States	Vanderbilt University	Nashville	Tennessee
United States	Integris Health	Oklahoma City	Oklahoma
United States	Oregon Health and Science University	Portland	Oregon
United States	University of Utah	Salt Lake City	Utah
United States	University of California	San Francisco	California
United States	Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creation of new MCS A-QOL item banks and short forms and validation of existing instruments	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.	Longitudinally: baseline through 6 months post-MCS implant and cross-sectionally through 10 years post-MCS implant