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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00219674 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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At-Home Automated External Defibrillator (AED) Training Study
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Scientific title:
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Home Automatic External Defibrillator Training for High-Risk Patients |
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Date of first enrolment:
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July 2004 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00219674 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
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Countries of recruitment
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United States
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Contacts
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Name:
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Susan K Damon, RN, BSN |
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Address:
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Telephone:
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206-296-4694 |
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Email:
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susan.damon@metrokc.gov |
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Affiliation:
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Name:
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Susan K Damon, RN, BSN |
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Address:
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Telephone:
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206-296-4694 |
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Email:
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susan.damon@metrokc.gov |
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Affiliation:
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Name:
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Thomas D Rea, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Emergency Medical Services, Public Health - Seattle and King County |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Angina, Unstable
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Chest Pain
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Congestive Heart Failure
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Heart Arrest
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Myocardial Infarction
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Intervention(s)
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Behavioral: Group I: Video training
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Behavioral: Group II: Video training + enhanced self-efficacy (SE)
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Behavioral: Group III: In-person training + enhanced SE
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Behavioral: Group IV: In-person training + enhanced SE + support
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Primary Outcome(s)
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AED skills retention when assessed at 9 months from enrollment date
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Psychological adjustment measured by a series of validated questionnaires administered at time of enrollment, 3 months, and 9 months
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Secondary ID(s)
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R01 HL074098-01A1
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RARC-0002-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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