LVAD CaregiversNCT06988995
Compassion Strikes Back
A study testing Information and Meeting in people with LVAD Caregivers and LVAD (Left Ventricular Assist Device), run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- LVAD Caregivers, LVAD (Left Ventricular Assist Device), Quality of Life (QOL)
- What is being tested?
- Information and Meeting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LVAD implantation or caregiver or patient with LVAD; over 18 years old; primary caregiver is a family member
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32605
Abigail Shonrock, PhD, 610-772-6099, ashonrock@ufl.edu
About this study
Official title: Compassion Strikes Back: Improving Dyadic Quality of Life for LVAD Patients and Caregivers
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
- Being tested
- Information, Meeting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InformationOther
Participants provided handouts with information on self-compassion
MeetingBehavioural
Participants meet with a psychological provider to receive information on self-compassion and training on how to utilize self-compassion
| Study group | Role | What they receive |
|---|---|---|
| Meeting | Experimental | Not described Receives: Behavioral: Meeting |
| Information | Active comparator | Not described Receives: Other: Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 months
Secondary outcomes (7)
NYHA
Measured: 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.
Measured: 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.
Measured: 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
Measured: 2 months
Perceived Stress Scale
Measured: 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.
Measured: 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).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LVAD CaregiversStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988995
- Sponsor's protocol ID
- IRB202500512
- Status last verified
- Jun 2026
- First submitted
- 5 May 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41909489
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassion Strikes Back: Improving Dyadic Quality of Life for LVAD Patients and Caregivers
- ClinicalTrials.gov ID
- NCT06988995
- Acronym / sponsor ID
- IRB202500512
- Conditions
- LVAD Caregivers, LVAD (Left Ventricular Assist Device), Quality of Life (QOL), Self-Compassion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meeting | Experimental | Behavioral: Meeting |
| Information | Active comparator | Other: Information |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- LVAD implantation or caregiver or patient with LVAD; over 18 years old; primary caregiver is a family member
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InformationParticipants provided handouts with information on self-compassion | Other | Information |
| MeetingParticipants meet with a psychological provider to receive information on self-compassion and training on how to utilize self-compassion | Behavioural | Meeting |
Primary outcome
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.
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.
7 secondary outcomes
NYHA
Time frame: 2 months
Cardiac Self-Efficacy
Time frame: 2 months
General Self-Efficacy
Time frame: 2 months
Illness Denial
Time frame: 2 months
Perceived Stress Scale
Time frame: 2 months
Caregiver Burden
Time frame: 2 months
Acceptability & Feasibility of Intervention
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Derived from this study: PubMed 41909489Shonrock 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information and Meeting in people with LVAD Caregivers and LVAD (Left Ventricular Assist Device), run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-compassion (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06988995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.