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Myocardial InfarctionPhase 2NCT00219674

At-Home Automated External Defibrillator (AED) Training Study

A Phase 2 study testing Group I: Video training, Group II: Video training + enhanced self-efficacy (SE) and Group III: In-person training + enhanced SE in people with Myocardial Infarction and Heart Arrest, run by Public Health - Seattle and King County at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction, Heart Arrest, Chest Pain
What is being tested?
Group I: Video training, Group II: Video training + enhanced self-efficacy (SE) and Group III: In-person training + enhanced SE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
305 participants
Where
1 siteUnited States
Study dates
Jul 2004to Mar 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Division of Emergency Medical Services, Public Health - Seattle and King County

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: Home Automatic External Defibrillator Training for High-Risk Patients

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.

Read the 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.

Being tested
Group I: Video training, Group II: Video training + enhanced self-efficacy (SE), Group III: In-person training + enhanced SE, Group IV: In-person training + enhanced SE + support
Keywords
education, training, defibrillators, home defibrillators, automated external defibrillators, psychological adjustment
Medical subject headings
Myocardial Infarction, Heart Arrest, Chest Pain, Heart Failure, Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group I: Video trainingBehavioural

    Participants will receive the AED with a video that provides "instructional" training.

  • Group II: Video training + enhanced self-efficacy (SE)Behavioural

    Partcipants will receive the AED with instructional video, a manikin, and additional training materials by mail.

  • Group III: In-person training + enhanced SEBehavioural

    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 + supportBehavioural

    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.

Study groups in NCT00219674
Study groupRoleWhat they receive
2Active comparatorGroup II
Receives: Behavioral: Group II: Video training + enhanced self-efficacy (SE)
3Active comparatorNot described
Receives: Behavioral: Group III: In-person training + enhanced SE
4Active comparatorNot described
Receives: Behavioral: Group IV: In-person training + enhanced SE + support
1Active comparatorGroup I
Receives: Behavioral: Group I: Video training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AED skills retention when assessed at 9 months from enrollment date

    Measured: 9 months

Secondary outcomes (1)
  1. Psychological adjustment measured by a series of validated questionnaires administered at time of enrollment, 3 months, and 9 months

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startJul 2004
  3. Primary completionMar 2009
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00219674
Sponsor's protocol ID
R01HL074098-01A1
Status last verified
Oct 2014
First submitted
13 Sep 2005
Last updated
29 Oct 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Meischke H, Diehr P, Phelps R, Damon S, Rea T. Psychologic effects of automated external defibrillator training: a randomized trial. Heart Lung. 2011 Nov-Dec;40(6):502-10. doi: 10.1016/j.hrtlng.2010.12.009. Epub 2011 Mar 16.

    PubMed 21411144

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Group I: Video training, Group II: Video training + enhanced self-efficacy (SE) and Group III: In-person training + enhanced SE in people with Myocardial Infarction and Heart Arrest, run by Public Health - Seattle and King County at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AED skills retention when assessed at 9 months from enrollment date (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00219674, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2014.

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