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临床试验/NCT00219674
NCT00219674已完成2 期

Home Automatic External Defibrillator Training for High-Risk Patients

Public Health - Seattle and King County2 个研究点 分布在 1 个国家目标入组 305 人开始时间: 2004年7月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
305
试验地点
2
主要终点
AED skills retention when assessed at 9 months from enrollment date

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

AED skills retention when assessed at 9 months from enrollment date

时间窗: 9 months

次要结局

  • Psychological adjustment measured by a series of validated questionnaires administered at time of enrollment, 3 months, and 9 months(9 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Susan Damon

Program Manager

Public Health - Seattle and King County

研究点 (2)

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