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At-Home Automated External Defibrillator (AED) Training Study
This study is currently recruiting participants.
Study NCT00219674   Information provided by Public Health - Seattle and King County
First Received: September 13, 2005   Last Updated: February 9, 2006   History of Changes

September 13, 2005
February 9, 2006
July 2004
 
  • AED skills retention when assessed at 9 months from enrollment date
  • Psychological adjustment measured by a series of validated questionnaires administered at time of enrollment, 3 months, and 9 months
  • AED skills retention when assessed at 9 months from enrollment date.
  • Psychological adjustment measured by a series of validated questionnaires administered at time of enrollment, 3 months, and 9 months.
Complete list of historical versions of study NCT00219674 on ClinicalTrials.gov Archive Site
 
 
 
At-Home Automated External Defibrillator (AED) Training Study
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.

Phase II
Interventional
Educational/Counseling/Training, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
  • 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
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
300
 
 

Inclusion Criteria:

  • Hospitalized for acute myocardial infarction, unstable angina, cardiac chest pain, congestive heart failure with ejection fraction less than 40, a cardiac procedure with a documented history of coronary artery disease
  • Resides in Pierce, King, or Snohomish Counties, Washington (WA)
  • Lives with someone physically and mentally able to operate an AED
  • Able to provide written informed consent
  • Has a telephone

Exclusion Criteria:

  • Lives in a nursing home
  • Do not resuscitate (DNR) orders checked on chart
  • Suffers from a severe co-morbidity that prevents them from participating in a long-term study
  • Has an implantable cardioverter defibrillator
  • Non-English speaking patient and/or family member/significant other
Both
18 Years and older
No
Contact: Susan K Damon, RN, BSN 206-296-4694 susan.damon@metrokc.gov
United States
 
NCT00219674
 
R01 HL074098-01A1, RARC-0002-01
Public Health - Seattle and King County
 
Principal Investigator: Thomas D Rea, MD, MPH Division of Emergency Medical Services, Public Health - Seattle and King County
Public Health - Seattle and King County
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP