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

Sudden Cardiac Arrest Clinical Trial

Official title:

Nursing Interventions Following Sudden Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226681
• Other study ID #: 4766
• Secondary ID: R01NR004766
• Status: Completed
• Phase: Phase 1
• First received: September 23, 2005
• Last updated: September 9, 2008
• Start date: September 1999
• Est. completion date: August 2004

Study information

• Verified date: September 2008
• Source: National Institute of Nursing Research (NINR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Heart Arrest
• Sudden Cardiac Arrest

Intervention

Behavioral:
• Nursing Telephone Support Protocol

• Usual Care

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD		Baseline, 1- and 3-months from implantation	No
Secondary	Improved physical functioning		Baseline, 1- and 3-months from implantation	No
Secondary	Improved psychological adjustment		Baseline, 1- and 3-months from implantation	No
Secondary	Improved self-efficacy		Baseline, 1- and 3-months from implantation	No
Secondary	Lower health care use		Baseline, 1- and 3-months from implantation	No