Mechanical Support Measures of Adjustment and QOL (MCS A-QOL)

February 14, 2022 updated by: Kathleen Grady, Northwestern University

Mechanical Circulatory Support: Measures of Adjustment and Quality of Life

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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

895

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • University of California, San Diego
      • San Francisco, California, United States, 94117
        • University of California
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Colorado
      • Denver, Colorado, United States, 80208
        • University of Colorado
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Integris Health
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Tennessee
      • Nashville, Tennessee, United States, 37240
        • Vanderbilt University
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study is enrolling patients with advanced heart failure who require Mechanical Circulatory Support (MCS) to help the heart pump blood.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1: Longitudinal assessment
Assessments will be performed pre-MCS, 3 months post-MCS and 6 months post-MCS. Participants in this group must be scheduled for MCS implant.
Group 2: Cross-sectional assessment
A one-time assessment will be performed on participants who are post-MCS implant (between 3 months and 10 years post-implant). Participants in this group must already have an MCS device in place.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Kathleen L Grady, RN, PhD, Northwestern University
  • Principal Investigator: Elizabeth A Hahn, MA, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2016

Primary Completion (Actual)

February 28, 2020

Study Completion (Actual)

February 28, 2020

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (Estimate)

February 7, 2017

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00201984
  • 1R01HL130502-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All published resources generated during the course of this work will be made available to other investigators upon request. Per study procedure, the investigators will respond to requests from other researchers to use de-identified data and make MCS A-QOL measurement system available to both researchers and clinicians for use.

Data that were derived from the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) will only be shared per data sharing protocols.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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