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

Phase 1

Completed

• Conditions: Sudden Cardiac Arrest
• Interventions: Behavioral: Nursing Telephone Support Protocol; Behavioral: Usual Care

• Registration Number: NCT00226681
• Lead Sponsor: National Institute of Nursing Research (NINR)

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

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 Timeline

• Study Start: 1999-09
• Primary Completion: 2004-08
• Study Completion: 2004-08
• Study First Submitted: 2005-09-23
• Study First Submitted QC: 2005-09-23
• Study First Posted: 2005-09-27
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-09
• Last Update Posted: 2008-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Nursing Telephone Support Protocol	-
2	Usual Care	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Improved physical functioning	Baseline, 1- and 3-months from implantation
Improved psychological adjustment	Baseline, 1- and 3-months from implantation
Improved self-efficacy	Baseline, 1- and 3-months from implantation
Lower health care use	Baseline, 1- and 3-months from implantation

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States