At-Home Automated External Defibrillator (AED) Training Study

Myocardial Infarction Clinical Trial

Official title:

Home Automatic External Defibrillator Training for High-Risk Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219674
• Other study ID #: R01HL074098-01A1
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: October 28, 2014
• Start date: July 2004
• Est. completion date: March 2011

Study information

• Verified date: October 2014
• Source: Public Health - Seattle and King County
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: March 2011
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Angina, Unstable
• Chest Pain
• Congestive Heart Failure
• Heart Arrest
• Heart Failure
• Myocardial Infarction

Intervention

Behavioral:
• Group I: Video training
Participants will receive the AED with a video that provides "instructional" training.
• Group II: Video training + enhanced self-efficacy (SE)
Partcipants will receive the AED with instructional video, a manikin, and additional training materials by mail.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Division of Emergency Medical Services, Public Health - Seattle and King County	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Public Health - Seattle and King County	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AED skills retention when assessed at 9 months from enrollment date		9 months	Yes
Secondary	Psychological adjustment measured by a series of validated questionnaires administered at time of enrollment, 3 months, and 9 months		9 months	No