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OpenTrials
Completed

NCT Number: NCT00226681

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

To determine if an education and support nursing intervention program helped sudden cardiac arrest survivors adjust to the event and to getting an ICD

Completed

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Key information

Conditions

Sudden Cardiac Arrest Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nursing Telephone Support Protocol

Behavioral

Usual Care

Behavioral

Primary outcomes

  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

    Time frame: Baseline, 1- and 3-months from implantation

Secondary outcomes

  1. Improved physical functioning

    Time frame: Baseline, 1- and 3-months from implantation

  2. Improved psychological adjustment

    Time frame: Baseline, 1- and 3-months from implantation

  3. Improved self-efficacy

    Time frame: Baseline, 1- and 3-months from implantation

  4. Lower health care use

    Time frame: Baseline, 1- and 3-months from implantation

Sponsors and collaborators

Lead sponsor

National Institute of Nursing Research (NINR)

Nih

Registry information

Official study title

Nursing Interventions Following Sudden Cardiac Arrest

Important dates

Study start
1999
Primary completion
2004
Study completion
2004
First posted
Sep 27, 2005
Registry last updated
Sep 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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