At-Home Automated External Defibrillator (AED) Training Study
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|ClinicalTrials.gov Identifier: NCT00219674|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 29, 2014
|Condition or disease||Intervention/treatment||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 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||305 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Home Automatic External Defibrillator Training for High-Risk Patients|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2011|
Active Comparator: 2
Behavioral: Group II: Video training + enhanced self-efficacy (SE)
Partcipants will receive the AED with instructional video, a manikin, and additional training materials by mail.
|Active Comparator: 3||
Behavioral: Group III: In-person training + enhanced SE
Participants will receive a face-to-face training session in their home as well as the AED with instructional video, manikin and training materials.
|Active Comparator: 4||
Behavioral: Group IV: In-person training + enhanced SE + support
Participants will receive a face-to-face training session in their home as well as the AED, instructional video, manikin, and a resource manual with information to enhance the family member's confidence in their role as care provider.
Active Comparator: 1
Behavioral: Group I: Video training
Participants will receive the AED with a video that provides "instructional" training.
- AED skills retention when assessed at 9 months from enrollment date [ Time Frame: 9 months ]
- Psychological adjustment measured by a series of validated questionnaires administered at time of enrollment, 3 months, and 9 months [ Time Frame: 9 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219674
|United States, Washington|
|Division of Emergency Medical Services, Public Health - Seattle and King County|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Thomas D Rea, MD, MPH||Division of Emergency Medical Services, Public Health - Seattle and King County|