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Nurses Helping Sudden Cardiac Arrest Survivors Recover After Getting An Implantable Cardioverter Defibrillator (ICD)

NCT ID: NCT00226681

Last Updated: 2008-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2004-08-31

Brief Summary

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

Detailed Description

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This study is one of the first large randomized clinical trials of nursing interventions aimed at improving health outcomes after receiving an ICD. Written informed consent was used in the study.

Conditions

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Sudden Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Nursing Telephone Support Protocol

Intervention Type BEHAVIORAL

2

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Interventions

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Nursing Telephone Support Protocol

Intervention Type BEHAVIORAL

Usual Care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role lead

Responsible Party

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University of Washington; Biobehavioral Nursing & Health Systems

Principal Investigators

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Cynthia Dougherty, ARNP, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15613121 (View on PubMed)

Other Identifiers

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R01NR004766

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4766

Identifier Type: -

Identifier Source: org_study_id