Improving dyadic quality of life for left ventricular assistive devices patients and caregivers: Rationale & design of the Compassion Strikes Back pilot.
Abigail T Shonrock, Tommy Cohen, Tony Calkins...
https://pubmed.ncbi.nlm.nih.gov/41909489/Actively Recruiting
Led by University of Florida · Updated on 2026-06-29
40
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying how to improve quality of life for patients with Left Ventricular Assist Devices LVAD and their caregivers during the critical transition from hospital to home after LVAD implantation. This study addresses mental health concerns and lowered quality of life commonly experienced by these patients and their families following surgery and discharge. Participants will be randomly assigned to one of two groups one group receives handouts with information on self-compassion, and the other group meets with a psychological provider to learn about self-compassion and how to apply it. The study includes two surveys one conducted during the hospital stay and a follow-up survey two months after discharge during a cardiologist appointment. Throughout the study, participants complete assessments related to self-compassion, quality of life, cardiac self-efficacy, perceived stress, caregiver burden, and acceptability of the intervention. Researchers monitor mental health and quality of life changes over two months, with possible contact for any missing survey data. The total participation time covers the hospital stay and the two-month follow-up period.
CONDITIONS
Compassion Strikes Back
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University of Florida
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Behavioral meeting with self‑compassion training | Self‑compassion information only |
|---|---|---|
| What it is | Behavioral meeting where a psychological provider presents self‑compassion principles and teaches how to apply them | Provision of handouts containing information about self‑compassion without additional training |
| Role in trial | Investigational behavioral intervention arm involving active training | Active comparator arm delivering self‑compassion information only |
| Primary use | To evaluate whether interactive self‑compassion training improves caregiver and patient quality of life | To provide information on self‑compassion as a control condition |
| How it is given or performed | Live meeting with a psychological provider to deliver self‑compassion information and training | Distribution of printed or digital handouts explaining self‑compassion |
| Evidence status | This pilot randomized study is testing whether behavioral self‑compassion training may improve quality of life; prior observational data suggest self‑compassion relates to better psychological adjustment in LVAD patients | Handouts alone serve as control; no prior evidence indicates equivalence or impact on quality of life in this context |
| Important limitations | Small pilot size limits generalizability; behavioral effect not yet established | Passive educational materials may not be sufficient to change psychological outcomes |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - During hospital stay
Participants complete a survey during their hospital stay after LVAD implantation.
1 survey session
Duration - 2 months post-discharge
Participants receive either information handouts or a meeting with a psychological provider. They complete a follow-up survey at 2 months after hospital discharge during their cardiologist appointment.
1 follow-up visit and survey
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Abigail T Shonrock, Tommy Cohen, Tony Calkins...
https://pubmed.ncbi.nlm.nih.gov/41909489/University of Florida
Lead Sponsor