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

• Sponsor: National Institute of Nursing Research (NINR) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00226681
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Duration (Months): 59
• Patients Per Site Per Month: 2.5

Study Details

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
• 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: Sep 1, 1999
• Actual Primary Completion Date: Aug 1, 2004
• Actual Study Completion Date: Aug 1, 2004

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 [Baseline, 1- and 3-months from implantation]

Secondary Outcome Measures

1. Improved physical functioning [Baseline, 1- and 3-months from implantation]

2. Improved psychological adjustment [Baseline, 1- and 3-months from implantation]

3. Improved self-efficacy [Baseline, 1- and 3-months from implantation]

4. Lower health care use [Baseline, 1- and 3-months from implantation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00226681
• Other Study ID Numbers: 4766; R01NR004766
• First Posted: Sep 27, 2005
• Last Update Posted: Sep 10, 2008
• Last Verified: Sep 1, 2008

• Additional relevant MeSH terms: Heart Arrest; Death, Sudden, Cardiac

Study Results

No Results Posted as of Sep 10, 2008