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Sponsors and Collaborators: |
Columbia University National Institute of Neurological Disorders and Stroke (NINDS) |
---|---|
Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00415389 |
The purposes of this study are to determine the effectiveness of an interactive stroke educational program compared to standard educational materials and usual care, to increase stroke knowledge, and to improve emergency room arrival times upon onset of stroke symptoms.
Condition | Intervention | Phase |
---|---|---|
Stroke |
Behavioral: interactive educational program Behavioral: usual medical care |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Stroke Warning Information and Faster Treatment Study (SWIFT) |
Estimated Enrollment: | 1400 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
interactive educational program
|
Behavioral: interactive educational program
2-session interactive stroke educational program
|
2: Active Comparator
usual medical care
|
Behavioral: usual medical care
standard educational materials and usual care
|
Rapid diagnosis and treatment of acute ischemic stroke is critical to reduce disability and death caused by stroke. While recombinant tissue plasminogen activator, or rt-PA, is the only approved treatment for acute ischemic stroke, less than 2-3 percent of individuals with stroke actually receive treatment. The inability to capture acute ischemic stroke cases within 3 hours of symptom onset is one critical factor. Populations at highest risk for stroke are significantly undereducated about the need for rapid, intervention upon onset of stroke symptoms. This is especially true among vulnerable populations including African Americans, Hispanics, and the poor.
The purpose of this study is to evaluate the effectiveness of a 2-session, culturally-sensitive, interactive stroke educational program compared to standard educational materials and usual care. In this study, the scientists will determine if the interactive program increases knowledge about stroke, and results in earlier arrival to the emergency room in the case of stroke.
The study will enroll 1400 individuals who have had a stroke or transient ischemic attack (TIA). Participants will be randomized to receive usual medical care——which includes standard educational information on stroke, stroke warning signs and risk factors——or usual medical care plus a 2-session interactive stroke educational program. All participants will be administered pre and post (30 days and 1 year) intervention stroke knowledge/behavior surveys. In additional, participants will be contacted every 12 months to check health status and document new stroke events associated with emergency room arrival time.
The SWIFT study is part of the Specialized Program for Translational Research in Acute Stroke (SPOTRIAS), which seeks to understand why certain people may be at increased risk for stroke. The goal of the study is to increase stroke knowledge, change behavior, and improve emergency room arrival times upon onset of stroke symptoms.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Thania Perez, MD | 212-342-1498 | tperez@neuro.columbia.edu |
Contact: Bernadette Boden-Albala, DrPH | 212-305-0501 | bb87@columbia.edu |
United States, New York | |
Neurological Institute, 710 W 168th Street, 6th Floor, Room 640 | Recruiting |
New York, New York, United States, 10032 | |
Contact: Thania Perez, MD 212-342-1498 tperez@neuro.columbia.edu | |
Principal Investigator: Bernadette Boden-Albala, DrPH |
Principal Investigator: | Bernadette Boden-Albala, DrPH | Columbia University Medical Center |
Investigator: | Ralph, Sacco, MD, MS | Co-Investigator, Columbia University Medical Center |
Investigator: | Joshua I Stillman, MD, MPH | Co-Investigator, Columbia University Medical Center |
Investigator: | Clinton B. Wright, MD, MS | Co-Investigator, Columbia University Medical Center |
Responsible Party: | Columbia University ( Bernadette Boden-Albala, Dr PH ) |
Study ID Numbers: | P50NS049060 |
Study First Received: | December 21, 2006 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00415389 |
Health Authority: | United States: Federal Government |
Stroke interactive educational program acute ischemic stroke |
Cerebral Infarction Stroke Vascular Diseases Brain Ischemia Central Nervous System Diseases |
Brain Infarction Ischemia Brain Diseases Infarction Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |