Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 23, 2005
September 9, 2008
September 1999
August 2004   (final data collection date for primary outcome measure)
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 ]
To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD
Complete list of historical versions of study NCT00226681 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Nurses Helping Sudden Cardiac Arrest Survivors Recover After Getting An Implantable Cardioverter Defibrillator (ICD)
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

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Sudden Cardiac Arrest
  • Behavioral: Nursing Telephone Support Protocol
  • Behavioral: Usual Care
  • Experimental: 1
    Intervention: Behavioral: Nursing Telephone Support Protocol
  • Active Comparator: 2
    Intervention: Behavioral: Usual Care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
August 2004
August 2004   (final data collection date for primary outcome measure)

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.
Both
12 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00226681
4766, R01NR004766
Yes
Cynthia M. Dougherty ARNP, PhD, University of Washington; Biobehavioral Nursing & Health Systems
National Institute of Nursing Research (NINR)
Not Provided
Principal Investigator: Cynthia Dougherty, ARNP, PhD University of Washington
National Institute of Nursing Research (NINR)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP