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


Title Mechanical Circulatory Support: Measures of Adjustment and Quality of Life
Therapeutic Area Cardiac Failure, Cardiomyopathy, Congestive Heart Failure, Heart Diseases, Heart Failure
Principal Investigator Michael Kiernan, MD
Min Age 19 Years
Gender Both
Contact Michael Kiernan, MD
617 636-2538
More Information https://clinicaltrials.gov/ct2/show/NCT03044535

Overview

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. The investigators refer to this measurement system as Mechanical Circulatory Support: Adjustment and Quality of Life (MCS A-QOL).

Study Details

Inclusion Criteria

  • Patients age ≥ 19 years and able to speak and understand English
  • Scheduled to have or currently have an implanted continuous flow mechanical circulatory support device (i.e. VAD)
  • Sufficient cognitive ability to provide self-report data on a computer touchscreen/standard computer and/or on paper-based forms with minimal assistance.

Exclusion Criteria

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

Study Requirements

This study consists of two groups of subjects. Each group has a different amount of participation required. For each group, some of the study procedures must take place at Tufts Medical Center, while other study procedures can be completed electronically in one’s home via an e-mailed link if preferred. Any study procedure that occurs at Tufts Medical Center will be scheduled to happen on the same day of a previously scheduled appointment, i.e. there will be no extra visits to Tufts Medical Center in order to take part in the study.

Procedures for Group One:

  • Baseline Assessment (About 30 minutes):
    • Occurs within 30 days of your scheduled LVAD implant
    • A six-minute walk test (a measurement of the distance walked on level ground in 6 minutes).
    • Paper and online questionnaires about how well you are feeling both physically and mentally
  • Month 3 Assessment (About 60 minutes):
    • Occurs 3 months after your LVAD implant A six-minute walk test (a measurement of the distance walked on level ground in 6 minutes).
    • Questionnaires about how well you are feeling both physically and mentally
  • Month 6 Assessment (About 60 minutes):
    • Occurs 6 months after your LVAD implant
    • A six-minute walk test (a measurement of the distance walked on level ground in 6 minutes).
    • Questionnaires about how well you are feeling both physically and mentally

Procedures for Group Two

  • Assessment (About 60 minutes):
    • Occurs only at one of the following time points after your LVAD implant
      • 3, 6, 12, 18, 24, 30, 36, 42, or 48 months
    • A six-minute walk test (a measurement of the distance walked on level ground in 6 minutes).
    • Paper and online questionnaires about how well you are feeling both physically and mentally