The Stroke Warning Information and Faster Treatment Study (SWIFT)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10032
- Neurological Institute, 710 W 168th Street, 6th Floor, Room 640
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Diagnosed with cerebral infarction/TIA hospitalized at New York Presbyterian Hospital (Milstein Hospital and Allen Pavilion)
- 18 year-old and older at onset of the stroke
- Self-identified as of White, Black or Hispanic race-ethnicity
- Living in a household with a telephone
Exclusion Criteria:
- Patients unable to give informed consent
- Discharged to nursing home or requiring 24 hour care.
- A 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 1
interactive educational program
|
2-session interactive stroke educational program
|
|
Aktiv komparator: 2
usual medical care
|
standard educational materials and usual care
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Surveillance methodologies will 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 month and one year post stroke event.
Tidsramme: at one month and one year post stroke event
|
at one month and one year post stroke event
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Bernadette Boden-Albala, DrPH, Columbia University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
- Boden-Albala B, Stillman J, Roberts ET, Quarles LW, Glymour MM, Chong J, Moats H, Torrico V, Parides MC. Comparison of Acute Stroke Preparedness Strategies to Decrease Emergency Department Arrival Time in a Multiethnic Cohort: The Stroke Warning Information and Faster Treatment Study. Stroke. 2015 Jul;46(7):1806-12. doi: 10.1161/STROKEAHA.114.008502. Epub 2015 Jun 11.
- Kerns JM, Heidmann D, Petty M, Prabhakaran S. Optimizing public health strategies for stroke education: need for a controlled trial. Am J Ther. 2011 Jan;18(1):81-90. doi: 10.1097/MJT.0b013e3181e123cd.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AAAA9948
- P50NS049060 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .