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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier:
NCT00226681
First received: September 23, 2005
Last updated: September 9, 2008
Last verified: September 2008
History of Changes
  Purpose

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 Intervention Phase
Sudden Cardiac Arrest
 Behavioral: Nursing Telephone Support Protocol
Behavioral: Usual Care
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Nursing Interventions Following Sudden Cardiac Arrest

Resource links provided by NLM:

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

Further study details as provided by National Institute of Nursing Research (NINR):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improved physical functioning [ Time Frame: Baseline, 1- and 3-months from implantation ] [ Designated as safety issue: No ]
  • Improved psychological adjustment [ Time Frame: Baseline, 1- and 3-months from implantation ] [ Designated as safety issue: No ]
  • Improved self-efficacy [ Time Frame: Baseline, 1- and 3-months from implantation ] [ Designated as safety issue: No ]
  • Lower health care use [ Time Frame: Baseline, 1- and 3-months from implantation ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: September 1999
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Nursing Telephone Support Protocol
Active Comparator: 2 Behavioral: Usual Care

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.

  Eligibility

Ages Eligible for Study:   12 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 23, 2005
Last Updated: September 9, 2008
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 23, 2013