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Eligibility
for people ages 19 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

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).

Official Title

Mechanical Circulatory Support: Measures of Adjustment and Quality of Life

Details

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.

The investigators will then explore ways to enhance patient care by using MCS A-QOL clinically. The investigators will develop and test a mobile CAT app to be used by patients and their health care providers. A printed computer-generated summary and interpretation of these measures will be shared with patients and their health care providers during clinic visits. They will also participate in semi-structured interviews to assess the user experience (i.e., understandability, usability, and acceptability) of the mobile app and printed reports.

Keywords

Quality of Life Heart Failure Cardiovascular Diseases mechanical circulatory support

Eligibility

For people ages 19 years and up

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 between 3 months and 4 years post-implant (i.e., 3, 6, 12, 18, 24, 30, 36, 42, and 48 months). 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

Group 3 Inclusion Criteria:

  1. Approximately 3 months post-primary (first time) implant of a continuous flow MCS device
  2. Left ventricular assist device (LVAD), with an implant strategy of bridge to transplant, destination therapy, or bridge to recovery
  3. Age>= 19 years and able to speak and understand English
  4. Has a smartphone
  5. Willing to participate and able to give written informed consent

Group 3 Exclusion Criteria:

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

Locations

  • Stanford University Medical Center accepting new patients
    Stanford, California, 94305, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Northwestern University
ID
NCT03044535
Study Type
Observational
Last Updated
February 1, 2017
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