Clinical trial Recruiting at 1 site Interventional Ages 18 to 80

Compassion Strikes Back — support for LVAD patients and their caregivers

Official title: Compassion Strikes Back: Improving Dyadic Quality of Life for LVAD Patients and Caregivers

Run by University of Florida · NCT06988995 · Data updated 2026-11-12

This project tests whether brief informational handouts or a short meeting with a psychologist can help adult LVAD patients and their primary family caregivers feel less stressed and improve quality of life during the first two months after hospital discharge.

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment40 (estimated)
SponsorUniversity of Florida
Academic / other
Locations1 site (Gainesville, Florida)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedJune 29, 2026
Trial IDNCT06988995 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults who recently had LVAD implantation or their primary family caregivers who are able to complete in-hospital and two-month follow-up surveys and do not have recent or unmanaged serious psychiatric conditions.

Probably not a fit

People with recent psychiatric hospitalization, active suicidal thoughts, unmanaged psychosis or bipolar disorder, active substance use disorder requiring immediate treatment, recent psychotherapy or other ongoing psychosocial trials, toxic patient-caregiver relationships, or extended post-implant hospital stays are excluded and may not benefit from this program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants are adults who either received a left ventricular assist device (LVAD) or are the primary family caregiver of an LVAD patient and will complete two surveys: one while in the hospital and one at a two-month post-discharge cardiology visit. The intervention consists of providing information resources and, for some participants, a brief meeting with a psychology provider to discuss mental health and coping strategies. Investigators will follow up if survey data are missing and exclude people with recent psychotherapy, recent psychiatric hospitalization, active suicidal ideation, unmanaged serious mental illness, active substance use disorder requiring treatment, toxic patient-caregiver dynamics, or prolonged hospital stays after implantation. The goal is to test low-burden supports to ease the early transition from hospital to home for patient-caregiver dyads.

Why it matters

Potential benefit: If successful, this approach could improve mental health and day-to-day quality of life for LVAD patients and reduce caregiver strain during the early home transition.

How similar studies have gone: Brief psychosocial supports and self-compassion interventions have shown benefits in other chronic illness and caregiver groups, but focused evidence for the early post-LVAD transition is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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).

Where it's running

  • University of Florida
    Gainesville, Florida, United States
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.