The Stroke Warning Information and Faster Treatment Study (SWIFT)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10032
- Neurological Institute, 710 W 168th Street, 6th Floor, Room 640
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:1
interactive educational program
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2-session interactive stroke educational program
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アクティブコンパレータ:2
usual medical care
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standard educational materials and usual care
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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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.
時間枠:at one month and one year post stroke event
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at one month and one year post stroke event
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Bernadette Boden-Albala, DrPH、Columbia University
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。