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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00226681
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : September 10, 2008
Sponsor:
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Sudden Cardiac Arrest Behavioral: Nursing Telephone Support Protocol Behavioral: Usual Care Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Nursing Interventions Following Sudden Cardiac Arrest
Study Start Date : September 1999
Primary Completion Date : August 2004
Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Behavioral: Nursing Telephone Support Protocol
Active Comparator: 2 Behavioral: Usual Care


Outcome Measures

Primary Outcome Measures :
  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 [ Time Frame: Baseline, 1- and 3-months from implantation ]

Secondary Outcome Measures :
  1. Improved physical functioning [ Time Frame: Baseline, 1- and 3-months from implantation ]
  2. Improved psychological adjustment [ Time Frame: Baseline, 1- and 3-months from implantation ]
  3. Improved self-efficacy [ Time Frame: Baseline, 1- and 3-months from implantation ]
  4. Lower health care use [ Time Frame: Baseline, 1- and 3-months from implantation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226681


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Cynthia Dougherty, ARNP, PhD University of Washington
More Information

Publications:
Responsible Party: Cynthia M. Dougherty ARNP, PhD, University of Washington; Biobehavioral Nursing & Health Systems
ClinicalTrials.gov Identifier: NCT00226681     History of Changes
Other Study ID Numbers: 4766
R01NR004766 ( U.S. NIH Grant/Contract )
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: September 10, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Heart Arrest
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Death
Pathologic Processes