Compassion Strikes Back — support for LVAD patients and their caregivers
Compassion Strikes Back: Improving Dyadic Quality of Life for LVAD Patients and Caregivers
NA · University of Florida · NCT06988995
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06988995 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: LVAD Caregivers, LVAD, Quality of Life, Self-Compassion