At-Home Automated External Defibrillator (AED) Training Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susan Damon, Public Health - Seattle and King County
ClinicalTrials.gov Identifier:
NCT00219674
First received: September 13, 2005
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Home Automatic External Defibrillator Training for High-Risk Patients

Resource links provided by NLM:


Further study details as provided by Public Health - Seattle and King County:

Primary Outcome Measures:
  • AED skills retention when assessed at 9 months from enrollment date [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Psychological adjustment measured by a series of validated questionnaires administered at time of enrollment, 3 months, and 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 305
Study Start Date: July 2004
Study Completion Date: March 2011
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Group II
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
Group I
Behavioral: Group I: Video training
Participants will receive the AED with a video that provides "instructional" training.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219674

Locations
United States, Washington
Division of Emergency Medical Services, Public Health - Seattle and King County
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Public Health - Seattle and King County
Investigators
Principal Investigator: Thomas D Rea, MD, MPH Division of Emergency Medical Services, Public Health - Seattle and King County
  More Information

No publications provided by Public Health - Seattle and King County

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Susan Damon, Program Manager, Public Health - Seattle and King County
ClinicalTrials.gov Identifier: NCT00219674     History of Changes
Other Study ID Numbers: R01 HL074098-01A1
Study First Received: September 13, 2005
Last Updated: October 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Public Health - Seattle and King County:
education
training, defibrillators
home defibrillators
automated external defibrillators
psychological adjustment

Additional relevant MeSH terms:
Angina, Unstable
Chest Pain
Heart Arrest
Heart Failure
Infarction
Myocardial Infarction
Angina Pectoris
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014