- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00226681
Nurses Helping Sudden Cardiac Arrest Survivors Recover After Getting An Implantable Cardioverter Defibrillator (ICD)
September 9, 2008 updated by: National Institute of Nursing Research (NINR)
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
150
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 90 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 2
|
|
EXPERIMENTAL: 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Baseline, 1- and 3-months from implantation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improved physical functioning
Time Frame: Baseline, 1- and 3-months from implantation
|
Baseline, 1- and 3-months from implantation
|
Improved psychological adjustment
Time Frame: Baseline, 1- and 3-months from implantation
|
Baseline, 1- and 3-months from implantation
|
Improved self-efficacy
Time Frame: Baseline, 1- and 3-months from implantation
|
Baseline, 1- and 3-months from implantation
|
Lower health care use
Time Frame: Baseline, 1- and 3-months from implantation
|
Baseline, 1- and 3-months from implantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1999
Primary Completion (ACTUAL)
August 1, 2004
Study Completion (ACTUAL)
August 1, 2004
Study Registration Dates
First Submitted
September 23, 2005
First Submitted That Met QC Criteria
September 23, 2005
First Posted (ESTIMATE)
September 27, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
September 10, 2008
Last Update Submitted That Met QC Criteria
September 9, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4766 (Sterling IRB)
- R01NR004766 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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