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LVAD Decision Aid for Heart Failure (VADDA Trial)

N/A
Waitlist Available
Led By Jennifer Blumenthal-Barby, PhD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-month
Awards & highlights

VADDA Trial Summary

The goal of this project is to develop a patient-centered decision aid for decision-making about end-stage heart failure treatment. This study seeks to create a decision aid that presents outcomes, risks, projected experiences, and uncertainties about Left Ventricular Assist Device (LVAD) placement to help patients make values-based decisions about placement. The investigators propose a mixed methods design involving a literature search of clinical evidence, semi-structured patient interviews, and quantitative data from a multi-site trial of patients receiving the decision aid compared to patients not receiving the aid.

Eligible Conditions
  • Heart Failure
  • LVAD Placement
  • Refusal of LVAD Placement
  • Left Ventricular Assist Device Caregivers

VADDA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Left Ventricular Assist Device (LVAD) Knowledge Scale
Secondary outcome measures
Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect
Decisional Conflict Scale
Number & Percentage of Participants Who Perceived a Strong Likelihood of Transplant
+23 more

VADDA Trial Design

2Treatment groups
Active Control
Group I: LVAD Decision AidActive Control1 Intervention
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
Group II: No LVAD Decision AidActive Control1 Intervention
The standard education processis institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterOTHER
3,002 Previous Clinical Trials
1,794,181 Total Patients Enrolled
6 Trials studying Heart Failure
219 Patients Enrolled for Heart Failure
Baylor College of MedicineLead Sponsor
1,006 Previous Clinical Trials
6,003,210 Total Patients Enrolled
13 Trials studying Heart Failure
3,420 Patients Enrolled for Heart Failure
The Methodist Hospital Research InstituteOTHER
275 Previous Clinical Trials
80,439 Total Patients Enrolled
4 Trials studying Heart Failure
256 Patients Enrolled for Heart Failure
~9 spots leftby Jul 2025
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