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NCT Number: NCT06988995

Compassion Strikes Back

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.

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Key information

Conditions

LVAD Caregivers LVAD (Left Ventricular Assist Device) Quality of Life (QOL) Self-Compassion

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32605, United States

Location status: Recruiting

Location contact

Abigail Shonrock, PhD

CONTACT

[email protected]

610-772-6099

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Information

Other

Participants provided handouts with information on self-compassion

Meeting

Behavioral

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

Primary outcomes

  1. Self-compassion

    Time frame: 2 months

    Level of self-compassion a participant reports using the Self-Compassion Scale - Short Form (Raes et al., 2011). Scores range from 1-5.

  2. QOL

    Time frame: 2 months

    Quality of Life will be measured using the 16 item Quality of Life Scale (Burckhardt et al., 1989). Scores range from 16-112, with higher scores indicating higher levels of quality of life.

Secondary outcomes

  1. NYHA

    Time frame: 2 months

  2. Cardiac Self-Efficacy

    Time frame: 2 months

    The Cardiac Self-Efficacy Scale (Sullivan et al., 1998) is a 13-item measure that measures self-efficacy in patients with cardiac problems across 2 subscales: maintain and control. Scores are averaged across the two subscales. Scores range from 0-4, with higher scores indicating higher confidence or perceived self-efficacy.

  3. General Self-Efficacy

    Time frame: 2 months

    General Self-efficacy will be measured by the General Self-Efficacy Scale (Weinman et al., 1995). The GSE is a 10-item scale with scores ranging from 10-40, with higher scores indicating more self-efficacy.

  4. Illness Denial

    Time frame: 2 months

    Illness denial will be measured using the Illness Denial Questionnaire. Caregivers will receive the caregiver version, and patients will receive the patient version. Both versions are 24-items, with scores ranging from 0-24. Higher scores indicate higher levels of denial

  5. Perceived Stress Scale

    Time frame: 2 months

  6. Caregiver Burden

    Time frame: 2 months

    Caregiver burden will be assessed using the Zarit Burden Interview - Short Form, which is a 12 item questionnaire assessing caregiver burden. Scores range from 0-48, with a score over 20 indicating high burden.

  7. Acceptability & Feasibility of Intervention

    Time frame: 2 months

    Participants will be asked about the feasibility and acceptability of the intervention they receive. Scores range from 0-5, with higher scores indicating greater acceptability and higher feasibility (i.e., the intervention felt easy to complete and use).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 25, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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