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Sponsored by: |
Public Health - Seattle and King County |
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Information provided by: | Public Health - Seattle and King County |
ClinicalTrials.gov Identifier: | NCT00219674 |
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.
Condition | Intervention | Phase |
---|---|---|
Myocardial Infarction Heart Arrest Chest Pain Congestive Heart Failure Angina, Unstable |
Behavioral: Group I: Video training Behavioral: Group II: Video training + enhanced self-efficacy (SE) Behavioral: Group III: In-person training + enhanced SE Behavioral: Group IV: In-person training + enhanced SE + support |
Phase II |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Home Automatic External Defibrillator Training for High-Risk Patients |
Estimated Enrollment: | 300 |
Study Start Date: | July 2004 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Susan K Damon, RN, BSN | 206-296-4694 | susan.damon@metrokc.gov |
United States, Washington | |
Division of Emergency Medical Services, Public Health - Seattle and King County | Recruiting |
Seattle, Washington, United States, 98104 | |
Contact: Susan K Damon, RN, BSN 206-296-4694 susan.damon@metrokc.gov | |
Principal Investigator: Thomas D Rea, MD, MPH |
Principal Investigator: | Thomas D Rea, MD, MPH | Division of Emergency Medical Services, Public Health - Seattle and King County |
Study ID Numbers: | R01 HL074098-01A1, RARC-0002-01 |
Study First Received: | September 13, 2005 |
Last Updated: | February 9, 2006 |
ClinicalTrials.gov Identifier: | NCT00219674 History of Changes |
Health Authority: | United States: Institutional Review Board |
education training, defibrillators home defibrillators automated external defibrillators psychological adjustment |
Heart Failure Heart Diseases Myocardial Ischemia Angina Pectoris Vascular Diseases Pain Heart Arrest |
Ischemia Chest Pain Signs and Symptoms Necrosis Infarction Myocardial Infarction Angina, Unstable |
Heart Failure Heart Diseases Myocardial Ischemia Angina Pectoris Vascular Diseases Heart Arrest Pain Ischemia |
Chest Pain Signs and Symptoms Necrosis Pathologic Processes Cardiovascular Diseases Infarction Angina, Unstable Myocardial Infarction |