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Stroke Interventions in Clinical Trials
Printable Version
SWIFT
Stroke Warning Information and Faster Treatment Study [SPOTRIAS]



Principal Investigator
Bernadette Boden-Albala, Dr PH

PI Address
Bernadette Boden-Albala, Dr PH
Columbia Presbyterian Hospital
Neurological Institute
710 W 168th Street
6th Floor, Room 640
New York, NY 10032

Ph: 212-305-0501
Email: bb87@columbia.edu

Contact Address
Thania Perez, MD
Columbia Presbyterian Hospital
Neurological Institute
710 W 168th Street
6th Floor, Room 640
New York, NY 10032

Ph: 212-342-1498

Sponsor



Trial Phase:Phase II
Study Size Actual:738
Study Size Planned:1400
Centers Actual:1
Centers Planned:1
Max Time from onset:24 Hours
Min Age:18
Follow-up Duration:12 Months
ISRCTN#NCT00415389
Status:
Open for enrollment for the AIM II- Stroke free Community participants associated to any community organization in the northern Manhattan area. -Closed enrollment for stroke survivor patients. -Date enrollment began at our site: 02/07/2005 Summary of any recent literature or interim findings: Not yet.

Purpose:
To determine the effectiveness of a culturally sensitive, interactive stroke educational program compared to standard educational materials and usual care, in increasing stroke knowledge, and improving emergency room arrival times upon onset of stroke symptoms.

Interventions:
Interactive Educational Program
2-session interactive stroke educational program

Location(s):
New York

Year Started: 2005

Design:
Interventional, educational/counseling/training, randomized, single blind, active control, parallel assignment, efficacy study.

Inclusion Criteria
Diagnosed with cerebral infarction/TIA hospitalized at New York Presbyterian Hospital (Milstein Hospital and Allen Pavilion); self-identified as White, Black or Hispanic race-ethnicity; living in a household with a telephone.

Exclusion Criteria
Discharged to nursing home or requiring 24 hour care; modified Rankin score > 4 at baseline; severe aphasia or severe cognitive impairment limiting comprehension; pre-stroke dementia history; patients with end stage cancer, or other medical conditions resulting in mortality </= 1 year.

Patient Involvement:
Patients will be randomized to receive usual medical care (standard educational information on stroke, stroke warning signs and risk factors) or usual medical care plus a 3-session interactive stroke educational program. All participants will be administered pre and post (30 days and 1 year) intervention stroke knowledge/behavior surveys. In addition, participants will be contacted every 12 months to check health status and document new stroke events associated with emergency room arrival time.

Primary Outcome:
Pre and post (30 days and 1 year) intervention stroke knowledge/behavior surveys to measure arrival times of acute strokes from stroke symptoms onset to ER among participants for the length of the study, as well as increase in stroke knowledge at one year post event.

Results:
Synopsis of the results to date in the Stroke Survivor SWIFT Study (AIMs):
We have successfully completed AIM 1 with an enrollment of about 1200 stroke and TIA participants which was to develop a health literate, culturally appropriate stroke preparedness intervention. We have randomized over 600 stroke/TIA patients to intervention and 600 to usual care.
To that end we have begun to analyze our data to evaluate the efficacy of the SWIFT intervention in terms of an increase in 30 day and 1 year knowledge surrounding stroke
preparedness as specified in AIM 2.
As part of AIM 2 we are in the process of following the participants to document stroke knowledge change and competency at 30 days and 1 year post stroke. We have had more that 1400 follow-up encounters.
Our AIM 3 is to evaluate differences in time to arrival in recurrent events among those randomized to intervention versus usual care control. Indeed we have documented over
180 reported outcome events and our lost to follow-up is less than 5 %. However, we were powered to detect a change in time to arrival among an estimated 250 stroke/TIA events over 5 years with an average of 2.8 to 3 years of follow-up and our follow-up is only 1.9 years.
SWIFT- stroke survivor cohort demographic:
Female: 49%
Male: 51%%
Race/Ethnicity distribution:
Black: 21%
White: 30%
Asian: 2%
Hispanic: 47%
* SWIFT Community (stroke free community members):
In addition to evaluating the efficacy of the SWIFT intervention in Stroke and TIA survivors, another goal of the SWIFT proposal was to evaluate the efficacy of a Community focused intervention, targeting stroke free subjects. Our goal was to identify and enroll about 1200 stroke free participants through existing community groups, CBO's and other organizational structures. Community enrollment efforts began in January, 2009. To date, we have enrolled over 300 participants, and continue our effort to reach our goal of 1200 before September 2010.
SWIFT community cohort demographic:
Female: 77%
Male: 23%
Race/Ethnicity distribution:
Black: 26.8%
White: 47.6%
Asian: 0.7%
Hispanic: 24.1%

Comments:
Scientific Name: The Stroke Warning Information and Faster Treatment Study (SWIFT)

Source of Information:
Presented at the 2007 International Stroke Conference [February 2007].
Presented at the 2008 International Stroke Conference [February 2008].

Web Links and Publications:
ISC Abstract 77
ISC

SWIFT Study Publications & Presentations List
SWIFT Study

Findings from the Swift Study
Abstract 186

SPOTRIAS

SWIFT
ClinicalTrial.gov

This information last updated on: 10/27/2009

Reviewed on: 05/14/2010.

UID: 744

   

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