NCT00219674

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

4.7 years

First QC Date

September 13, 2005

Last Update Submit

October 28, 2014

Conditions

Myocardial InfarctionHeart ArrestChest PainCongestive Heart FailureAngina, Unstable

Keywords

educationtraining, defibrillatorshome defibrillatorsautomated external defibrillatorspsychological adjustment

Outcome Measures

Primary Outcomes (1)

  • AED skills retention when assessed at 9 months from enrollment date

    9 months

Secondary Outcomes (1)

  • Psychological adjustment measured by a series of validated questionnaires administered at time of enrollment, 3 months, and 9 months

    9 months

Study Arms (4)

2

ACTIVE COMPARATOR

Group II

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

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

Group I

Behavioral: Group I: Video training

Interventions

Group I: Video trainingBEHAVIORAL

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

1
Group II: Video training + enhanced self-efficacy (SE)BEHAVIORAL

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

2
Group III: In-person training + enhanced SEBEHAVIORAL

Participants will receive a face-to-face training session in their home as well as the AED with instructional video, manikin and training materials.

3
Group IV: In-person training + enhanced SE + supportBEHAVIORAL

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.

4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Emergency Medical Services, Public Health - Seattle and King County

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • 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.

    PMID: 21411144DERIVED

MeSH Terms

Conditions

Myocardial InfarctionHeart ArrestChest PainHeart FailureAngina, Unstable

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPainNeurologic ManifestationsSigns and SymptomsAngina Pectoris

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Thomas D Rea, MD, MPH

    Division of Emergency Medical Services, Public Health - Seattle and King County

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Manager

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

July 1, 2004

Primary Completion

March 1, 2009

Study Completion

March 1, 2011

Last Updated

October 29, 2014

Record last verified: 2014-10

Locations

US(1)