Compassion Strikes Back
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Information, Meeting.
- Who it may be relevant to
- Registry conditions: LVAD Caregivers, LVAD (Left Ventricular Assist Device), Quality of Life (QOL), Self-Compassion. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Compassion Strikes Back: Improving Dyadic Quality of Life for LVAD Patients and Caregivers
Overview
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.
Interventions
- Other Information
Participants provided handouts with information on self-compassion - Behavioral Meeting
Participants meet with a psychological provider to receive information on self-compassion and training on how to utilize self-compassion
Primary outcome measures
- Self-compassion [Time frame: 2 months]
- QOL [Time frame: 2 months]
Secondary outcome measures (7)
- NYHA [Time frame: 2 months]
- Cardiac Self-Efficacy [Time frame: 2 months]
- General Self-Efficacy [Time frame: 2 months]
- Illness Denial [Time frame: 2 months]
- Perceived Stress Scale [Time frame: 2 months]
- Caregiver Burden [Time frame: 2 months]
- Acceptability & Feasibility of Intervention [Time frame: 2 months]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Florida — Gainesville
Publications
- Shonrock AT, Cohen T, Calkins T, Bell J, Perez S, Rios I, Villarroel L, Ahmed MM. Improving dyadic quality of life for left ventricular assistive devices patients and caregivers: Rationale & design of the Compassion Strikes Back pilot. Am Heart J Plus. 2026 Mar 18;64:100758. doi: 10.1016/j.ahjo.2026.100758. eCollection 2026 Apr. PMID 41909489
Identifiers
NCT: NCT06988995 · IRB202500512