40 Participants Needed

Information and Meetings for LVAD Patients' Quality of Life

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the quality of life for patients with a Left Ventricular Assist Device (LVAD) and their caregivers after hospital discharge. It examines whether providing information and support meetings can ease mental health concerns during the transition from hospital to home. Participants will complete surveys and may receive mental health resources or have brief meetings with a psychology provider. This trial suits LVAD patients and their family caregivers who have not received psychotherapy or support in the past three months and are not experiencing severe mental health issues. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance support systems for LVAD patients and their caregivers.

What prior data suggests that these methods are safe for improving quality of life in LVAD patients?

Research shows that the study's treatment involves providing information and holding meetings to support patients with a Left Ventricular Assist Device (LVAD) and their caregivers. This approach aims to improve mental health and quality of life after device implantation.

The "information" and "meeting" treatments themselves pose no specific safety concerns, as they involve educational support and counseling, not medications or surgeries. Thus, they are considered safe and manageable.

However, LVAD patients can face various challenges after device implantation. Studies have shown that while LVADs can extend life for some patients, they also carry risks such as infections, bleeding, and device issues. These risks relate to the LVAD itself, not the supportive treatments under study.

In summary, the "information" and "meeting" treatments in this study do not pose safety risks and aim to help patients manage the existing challenges of living with an LVAD.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how providing more information and regular meetings might boost the quality of life for patients with Left Ventricular Assist Devices (LVADs). Unlike standard care, which often focuses on medical management and device maintenance, this approach emphasizes patient education and emotional support. By potentially enhancing understanding and coping strategies, the trial aims to improve patients' overall well-being and satisfaction with their treatment.

What evidence suggests that this trial's treatments could improve quality of life for LVAD patients?

Research shows that people with Left Ventricular Assist Devices (LVADs) often face mental health challenges and reduced quality of life after surgery. In this trial, some participants will attend meetings with healthcare providers, such as psychologists, which have shown promise in supporting mental health. Early evidence suggests these meetings might reduce anxiety and depression in the months following LVAD implantation. Other participants will receive information handouts; although specific data is limited, educational support can help patients and caregivers better understand and manage their health. Both approaches in this trial aim to ease the transition from hospital to home for LVAD patients and their caregivers.23678

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are either patients with an LVAD implant or their primary caregivers, where the caregiver is a family member. It aims to help them transition from hospital to home and improve mental health and quality of life.

Inclusion Criteria

I am over 18 with an LVAD or care for someone with an LVAD, and the caregiver is a family member.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Hospital Phase

Participants complete a survey while in the hospital and may receive mental health information

During hospital stay
1 visit (in-person)

Post-Hospital Follow-up

Participants complete a follow-up survey at a 2-month post-hospital appointment with their cardiologist

2 months
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Information
  • Meeting

Trial Overview

The study tests whether providing information and possibly meeting with a psychology provider can enhance the well-being of LVAD patients and their caregivers post-hospitalization. Participants will complete surveys in-hospital and at a follow-up appointment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: MeetingExperimental Treatment1 Intervention
Group II: InformationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Citations

Impact of Left Ventricular Assist Devices on the Quality ...

Inpatient cardiac rehabilitation (CR) after LVAD implantation is linked to improved functional independence and reduced 30-day readmission rates ...

Patient-Reported Outcomes in Left Ventricular Assist ...

Initial evidence suggests an improvement in health status, anxiety, and depression in the first few months after LVAD implantation. However, PRO scores of ...

Impact of Left Ventricular Assist Devices on Quality of Life ...

Overall, these findings suggest that LVAD implantation does not significantly improve survival outcomes at 6 months, and the consistency across ...

Trends and Outcomes of Left Ventricular Assist Device ...

Patients implanted with a DT LVAD had lower 2-year survival compared with patients implanted as BTT (70.6% vs 78.3%; P < 0.01), likely due to ...

Time Spent Engaging in Health Care Among Patients With ...

Among 373 patients, the median number of days alive with LVAD was 390 (IQR: 158-840 days). Patients had a median number of 88 (IQR: 45-161) days ...

Short and long term outcomes of 200 patients supported by ...

Our analysis showed that after CF LVAD implantation, survival at 30 d was 94%, at 1 year 78%, at 2 year 71%, and at 4 years 45%. Our longest survivor has been ...

Outcomes of Left Ventricular Assist Device Implantation as ...

Patients supported with LVAD had significantly improved 1-year survival, from 25% to 52%, providing >2-fold survival benefit over maximal medical therapy.

Outcomes of Left Ventricular Assist Devices as Destination ...

Patients with LVADs are at risk for a range of adverse events, including infection, bleeding, thromboembolism, and device malfunction [23,24]. Infection remains ...