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

September 9, 2008 updated by: National Institute of Nursing Research (NINR)

Nursing Interventions Following Sudden Cardiac Arrest

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

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
EXPERIMENTAL: 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD
Time Frame: Baseline, 1- and 3-months from implantation
Baseline, 1- and 3-months from implantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Improved physical functioning
Time Frame: Baseline, 1- and 3-months from implantation
Baseline, 1- and 3-months from implantation
Improved psychological adjustment
Time Frame: Baseline, 1- and 3-months from implantation
Baseline, 1- and 3-months from implantation
Improved self-efficacy
Time Frame: Baseline, 1- and 3-months from implantation
Baseline, 1- and 3-months from implantation
Lower health care use
Time Frame: Baseline, 1- and 3-months from implantation
Baseline, 1- and 3-months from implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Primary Completion (ACTUAL)

August 1, 2004

Study Completion (ACTUAL)

August 1, 2004

Study Registration Dates

First Submitted

September 23, 2005

First Submitted That Met QC Criteria

September 23, 2005

First Posted (ESTIMATE)

September 27, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 10, 2008

Last Update Submitted That Met QC Criteria

September 9, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • 4766 (Sterling IRB)
  • R01NR004766 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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