Compassion Strikes Back

NCT06988995 | Recruiting

• 1 other identifier: IRB202500512
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Self-compassion

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

  2 months

• QOL

  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.

  2 months

Secondary Outcomes (7)

• NYHA

  2 months

• Cardiac Self-Efficacy

  2 months

• General Self-Efficacy

  2 months

• Illness Denial

  2 months

• Perceived Stress Scale

  2 months

Study Arms (2)

Meeting

EXPERIMENTAL

Behavioral: Meeting

Information

ACTIVE COMPARATOR

Other: Information

Interventions

Information OTHER

Participants provided handouts with information on self-compassion

Information

Meeting BEHAVIORAL

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

Meeting

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32605, United States

RECRUITING

Related Publications (1)

• 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 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 25, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)