NCT00226681CompletedPhase 1
Nursing Interventions Following Sudden Cardiac Arrest
National Institute of Nursing Research (NINR)2 sites in 1 country150 target enrollmentStarted: September 1, 1999Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- 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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 90 Years (Child, Adult, Older Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
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
- 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)
Investigators
Study Sites (2)
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