NCT00226681

Brief Summary

To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 1999

Longer than P75 for phase_1

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

September 1, 1999

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
Last Updated

September 10, 2008

Status Verified

September 1, 2008

Enrollment Period

4.9 years

First QC Date

September 23, 2005

Last Update Submit

September 9, 2008

Conditions

Sudden Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD

    Baseline, 1- and 3-months from implantation

Secondary Outcomes (4)

  • Improved physical functioning

    Baseline, 1- and 3-months from implantation

  • Improved psychological adjustment

    Baseline, 1- and 3-months from implantation

  • Improved self-efficacy

    Baseline, 1- and 3-months from implantation

  • Lower health care use

    Baseline, 1- and 3-months from implantation

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Nursing Telephone Support Protocol

2

ACTIVE COMPARATOR
Behavioral: Usual Care

Interventions

Nursing Telephone Support ProtocolBEHAVIORAL
1
Usual CareBEHAVIORAL
2

Eligibility Criteria

Age12 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • First time sudden cardiac arrest with ICD implantation during hospitalization, over age 21 years, working telephone in the home, deliverable address for 1 year

You may not qualify if:

  • Receiving an ICD for primary prevention of sudden cardiac arrest, inability to read, speak, or understand English, no telephone at home or no current address, cognitive or physical impairments that prohibited ability to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Dougherty CM, Lewis FM, Thompson EA, Baer JD, Kim W. Short-term efficacy of a telephone intervention by expert nurses after an implantable cardioverter defibrillator. Pacing Clin Electrophysiol. 2004 Dec;27(12):1594-602. doi: 10.1111/j.1540-8159.2004.00691.x.

    PMID: 15613121BACKGROUND

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cynthia Dougherty, ARNP, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

September 23, 2005

First Posted

September 27, 2005

Study Start

September 1, 1999

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

September 10, 2008

Record last verified: 2008-09

Locations

US(1)