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.
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
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- 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
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.
- Conditions
- Myocardial Infarction, Heart Arrest, Chest Pain, Congestive Heart Failure, Angina, Unstable
- 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 group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Group II Receives: Behavioral: Group II: Video training + enhanced self-efficacy (SE) |
| 3 | Active comparator | Not described Receives: Behavioral: Group III: In-person training + enhanced SE |
| 4 | Active comparator | Not described Receives: Behavioral: Group IV: In-person training + enhanced SE + support |
| 1 | Active comparator | Group I Receives: Behavioral: Group I: Video training |
What is being measured
The primary outcome is the main question the study is designed to answer.
AED skills retention when assessed at 9 months from enrollment date
Measured: 9 months
Secondary outcomes (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.
- First posted22 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionMar 2009
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Public Health - Seattle and King County
- Sponsor type
- Other government
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Susan Damon, Public Health - Seattle and King County
- Investigators
- Thomas D Rea, MD, MPH, Principal investigator, Division of Emergency Medical Services, Public Health - Seattle and King County
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Automatic External Defibrillator Training for High-Risk Patients
- ClinicalTrials.gov ID
- NCT00219674
- Acronym / sponsor ID
- R01HL074098-01A1
- Conditions
- Myocardial Infarction, Heart Arrest, Chest Pain, Congestive Heart Failure, Angina, Unstable
- Keywords
- education, training, defibrillators, home defibrillators, automated external defibrillators, psychological adjustment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Public Health - Seattle and King CountyOther government
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Behavioral: Group II: Video training + enhanced self-efficacy (SE)Group II |
| 3 | Active comparator | Behavioral: Group III: In-person training + enhanced SE |
| 4 | Active comparator | Behavioral: Group IV: In-person training + enhanced SE + support |
| 1 | Active comparator | Behavioral: Group I: Video trainingGroup I |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group I: Video trainingParticipants will receive the AED with a video that provides "instructional" training. | Behavioural | 1 |
| Group II: Video training + enhanced self-efficacy (SE)Partcipants will receive the AED with instructional video, a manikin, and additional training materials by mail. | Behavioural | 2 |
| Group III: In-person training + enhanced SEParticipants will receive a face-to-face training session in their home as well as the AED with instructional video, manikin and training materials. | Behavioural | 3 |
| Group IV: In-person training + enhanced SE + supportParticipants 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. | Behavioural | 4 |
Primary outcome
AED skills retention when assessed at 9 months from enrollment date
Time frame: 9 months
1 secondary outcome
Psychological adjustment measured by a series of validated questionnaires administered at time of enrollment, 3 months, and 9 months
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Derived from this study: PubMed 21411144Meischke 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.
Related trials for Myocardial Infarction
Recruiting
ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY
Myocardial Infarction (MI), Sudden Cardiac Death Due to Cardiac Arrhythmia
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas D Rea, MD, MPH principal investigator
Division of Emergency Medical Services, Public Health - Seattle and King County
1 site in 1 country: see every site and its status.
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.