Health TrialsbyHealthPanel

Compassion Strikes Back

ConditionsLVAD CaregiversLVAD (Left Ventricular Assist Device)Quality of Life (QOL)Self-Compassion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Information

    Other intervention

    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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: MeetingExperimental treatment 1 intervention
Group B: InformationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 months
2

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.

Time frame
2 months

Secondary outcomes

1

NYHA

Time frame
2 months
2

Cardiac Self-Efficacy

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.

Time frame
2 months
3

General Self-Efficacy

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.

Time frame
2 months
4

Illness Denial

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

Time frame
2 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Source ClinicalTrials.gov
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