Myocardial Infarction Clinical Trial
Official title:
Home Automatic External Defibrillator Training for High-Risk Patients
The purpose of the research is to determine the best automated external defibrillator (AED) training approach for high-risk patients and their family members with regard to AED skills retention and psychological adjustment.
In the past 3 decades, advances in the understanding of the resuscitation of cardiac arrest
have provided opportunities to strengthen the links in the chain of survival. Despite the
apparent progress, however, survival has remained poor. Cardiac arrest is a leading cause of
mortality in the US, accounting for up to 450,000 deaths annually. Eighty percent of all
cardiac arrest events are caused by the arrhythmia, ventricular fibrillation. Prompt
electrical defibrillation is the only effective therapy. The time interval from collapse to
attempted defibrillation is the most important determinant of outcome. The chance of
survival decreases on average by approximately 10-15% for every minute that elapses prior to
attempted defibrillation. Thus, methods to decrease the time interval between collapse and
electrical defibrillation represent a true opportunity to improve survival from cardiac
arrest.
Even in communities where emergency medical systems are best situated to treat cardiac
arrest, response intervals are on average greater than 6 minutes. The development of the
automated external defibrillator (AED) provides the possibility to decrease the interval
from collapse to defibrillation by enabling persons outside the traditional emergency
medical services response system who are typically not trained in rhythm recognition to
deliver life-saving therapy. The AED is a device that can be applied in case of cardiac
arrest and will assess the heart rhythm and instruct the bystander whether to provide a
shock. In addition, approximately 75% of cardiac arrests occur in the home and are witnessed
or found by a family member. Thus, a family responder AED program, where family members of
persons at relatively high risk of cardiac arrest are equipped and trained with AEDs, may in
part, decrease the interval from collapse to shock in cardiac arrest and improve outcome.
Persons who have recently been hospitalized for an acute coronary syndrome are known to be
at elevated risk for cardiac arrest. Indeed, the provision of an AED for home use is already
in practice. However, it is not clear what method should be used to train family members in
this potentially lifesaving set of skills. The purpose of the proposed study is to evaluate
4 different AED training methods to determine if the training approaches differentially
affect AED skill retention or psychological status. Although the programs span the spectrum
from streamlined to personalized and intensive, each approach constitutes a potential
real-world, generalizable AED training method.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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