Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy

Completed · Not applicable

Conditions studied: Sudden Cardiac Death, Heart Failure

In brief

VIVID is a prospective, multicenter, randomized clinical trial in African American patients that will to evaluate: (1) the effect of an educational video on knowledge of sudden cardiac death (SCD) and implantable cardioverter defibrillators (ICDs); (2) the effect of an educational video on the decision for ICD implantation, decisional conflict, and receipt of an ICD within 90 days; and 3) the effect of racial concordance between study patients and video participants (health care providers/patients) on the decision for ICD implantation, decisional conflict and ICD receipt within 90 days.

Key facts

Study ID

NCT02819973

Run by

Duke University

People needed

343

Starts

2016-07-01

Expected to finish

2020-04-30

Last updated by the study team

2021-04-21

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Non-hospitalized patients with ejection fraction ≤35%
• New York Heart Association class I-III heart failure,
• Age >21
• Eligible for an implantable cardioverter defibrillator (ICD) for the primary prevention of sudden cardiac death
• Self-identified race as black
• Provision of informed consent to participate in the study.

You may not qualify if…

• Life expectancy <12 months
• Listed for Orthotropic Heart Transplantation (OHT)
• Transplant (OHT) or OHT imminent within 12 months,
• History of ventricular fibrillation or sustained ventricular tachycardia without reversible causes
• ICD already implanted
• Myocardial infarction within the last 40 days,
• Coronary revascularization within the last 3 months,
• Patients who are unable to understand the study procedures due to cognitive or language barriers.
• Inpatients will be excluded from the study because decision-making processes are thought to be appreciably different in inpatients as compared with outpatients.
• Plan for subcutaneous ICD (Sub-Q ICD)

Where it is running

• University of California at San Francisco — San Francisco, California, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Georgia Arrhythmia Consultants and Research Institute — Macon, Georgia, United States
• Medstar Health Research Institute — Baltimore, Maryland, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Jackson Heart — Jackson, Mississippi, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• South Carolina Heart — Columbia, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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