Recruiting

LVAD Quality of Life

Sponsor:

University of Florida

Code:

NCT06988995

Conditions

LVAD Caregivers

LVAD (Left Ventricular Assist Device)

Quality of Life (QOL)

Self-Compassion

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Information

Meeting

Study Details

Brief summary:

Research has shown that LVAD patients and their caregivers typically experience increased mental health concerns and decreased quality of life following LVAD implantation and hospital discharge. The purpose of this study is to explore how to improve quality of life for LVAD patients and their caregivers in the initial transition from hospital to home after LVAD implantation.

Over the course of the study, participants will complete 2 surveys: one when participants are in the hospital and one at a 2-month post-hospital follow-up appointment with the participants' cardiologist. Participants may be contacted if there is data missing from surveys.

Participants may also be provided with information on improving mental health in the form of handouts or a brief meeting with a psychology provider.

Conditions

LVAD Caregivers

LVAD (Left Ventricular Assist Device)

Quality of Life (QOL)

Self-Compassion

Study ID

NCT06988995

Start date

Dec 1, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • LVAD implantation or caregiver or patient with LVAD; over 18 years old; primary caregiver is a family member

Exclusion Criteria:

  • Currently or in the past 3 months received psychotherapy or psychosocial or peer support; hospitalized for psychiatric reasons in the past 6 months; current, active suicidal thoughts or a reported suicide attempt within the past year; a current alcohol/substance use disorder that required immediate treatment; or a current or past thought disorder, psychosis, or unmanaged bipolar disorder; enrolled in another investigational research/clinical trial; toxic/negative dynamic between pt and caregiver; extended post-LVAD implantation course (i.e., more than 2 months in the hospital).

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Meeting

active comparator: Information

Interventions

Information

Participants provided handouts with information on self-compassion

Meeting

Participants meet with a psychological provider to receive information on self-compassion and training on how to utilize self-compassion

Primary outcome measure

  • Self-compassion [ Time Frame: 2 months ]
  • QOL [ Time Frame: 2 months ]

Central Contacts and Locations

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32605

Contacts

Abigail Shonrock, PhD

610-772-6099ashonrock@ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-06-29.