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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meeting | Experimental |
| |
| Information | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Information | Other | Participants provided handouts with information on self-compassion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| NYHA | 2 months | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Gainesville | Florida | 32605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41909489 | Derived | 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. |
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| Meeting |
| Behavioral |
Participants meet with a psychological provider to receive information on self-compassion and training on how to utilize self-compassion |
|
| 2 months |
| 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. | 2 months |
| 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 | 2 months |
| Perceived Stress Scale | 2 months |
| Caregiver Burden | 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. | 2 months |
| Acceptability & Feasibility of Intervention | 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). | 2 months |