Effectiveness of a Public Campaign to Increase Stroke Awareness in Reducing Prehospital Delay
Cluster Randomized Controlled Trial to Assess the Effectiveness of a Population-based Educational Campaign on Stroke Symptom Recognition in Reducing Pre-hospital Delay
The starting hypothesis is that a multilevel educational campaign, specifically developed for the local community, can increase public stroke awareness and reduce pre-hospital delay.
The effectiveness of such intervention will be evaluated according to a cluster randomized, stepped wedged design. The clusters are the four communities of the Area Vasta Emilia Nord, AVEN (Parma, Piacenza, Modena e Reggio Emilia). As analysis Units, we will consider the patients consecutively admitted to the six participating hospitals throughout the study period, for suspected stroke or transitory ischemic attack (TIA).
調査の概要
詳細な説明
After a baseline 3 month period, the educational campaign will be sequentially launched in the four communities over four 3 month periods, according to a computer-generated list. The comparison will be the"usual care".
Primary outcome measures: The proportion of patients arriving at the Emergency Department (ED) with suspected stroke or TIA within two hours.
Secondary outcome measures: the proportion of patients with confirmed stroke or TIA diagnosis; the proportion of ischemic stroke patients evaluated for recominanat Tissue Plasminogen Activator (rTPA) therapy; the proportion of patients treated with rTPA; time interval between arrival at the ED and CT scan; for patients treated with rTPA, time interval between arrival at the ED and therapy initiation (door to needle time); death and disability (assessed as modified Rankin Score 3-5) at 1 and 3 month from stroke onset.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Fidenza、イタリア、43016
- AUSL Parma
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Modena、イタリア
- Ospedale Civile S. Agostino Estense-Baggiovara-AUSL Modena
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Parma、イタリア、43100
- University Hospital of Parma
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Piacenza、イタリア
- Ospedale Guglielmo di Siliceto-AUSL Piacenza
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Reggio Emilia、イタリア
- Arcispedale Santa Maria Nuova of Reggio Emilia
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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:
- Patients consecutively admitted to the six participating hospitals for suspected stroke or transitory ischemic attack (TIA), defined as abrupt onset of focal or generalized neurologic deficit of vascular origin.
Exclusion Criteria:
- No information available on the time of stroke onset.
- No informed consent from patient or caregiver
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
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：コントロール
普段のお手入れ
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Information on stroke usually delivered at the community level.
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実験的：Intervention
Educational campaign
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Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services
他の名前：
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of early admission
時間枠：Time interval from stroke onset to arrival at the Emergency Department
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Proportion of patients arriving to the Emergency Department with suspected stroke or TIA within two hours
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Time interval from stroke onset to arrival at the Emergency Department
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Poor outcome at 1 month
時間枠：1 month from stroke onset
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Death or disability (modified Rankin Scale 3-6)at 1 month
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1 month from stroke onset
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Poor outcome at 3 months
時間枠：3 months from stroke onset
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Death or disability (modified Rankin Scale 3-6) at 3 months
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3 months from stroke onset
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Rate of thrombolysis
時間枠：Up to 4 hours and 30 minutes from stroke onset
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Proportion of patients given thrombolysis
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Up to 4 hours and 30 minutes from stroke onset
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Rate of thrombolysis activation
時間枠：Up to 3 hours from stroke onset
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Proportion of patients evaluated for thrombolysis
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Up to 3 hours from stroke onset
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Delay in CT scan
時間枠：Up to 12 hours from admission at the ED
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Time interval between arrival at the Emergency Department and CT scan
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Up to 12 hours from admission at the ED
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Door to needle time
時間枠：Up to 4 hours and 30 minutes from stroke onset
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Time interval between arrival at the ED and thrombolysis initiation
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Up to 4 hours and 30 minutes from stroke onset
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協力者と研究者
捜査官
- 主任研究者：Licia Denti, MD、Parma University Hospital
出版物と役立つリンク
一般刊行物
- Denti L, Caminiti C, Scoditti U, Zini A, Malferrari G, Zedde ML, Guidetti D, Baratti M, Vaghi L, Montanari E, Marcomini B, Riva S, Iezzi E, Castellini P, Olivato S, Barbi F, Perticaroli E, Monaco D, Iafelice I, Bigliardi G, Vandelli L, Guareschi A, Artoni A, Zanferrari C, Schulz PJ. Impact on Prehospital Delay of a Stroke Preparedness Campaign: A SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial). Stroke. 2017 Dec;48(12):3316-3322. doi: 10.1161/STROKEAHA.117.018135. Epub 2017 Nov 3.
- Caminiti C, Schulz P, Marcomini B, Iezzi E, Riva S, Scoditti U, Zini A, Malferrari G, Zedde ML, Guidetti D, Montanari E, Baratti M, Denti L; Educazione e Ritardo di Ospedalizzazione (E.R.O.I) study group. Development of an education campaign to reduce delays in pre-hospital response to stroke. BMC Emerg Med. 2017 Jun 24;17(1):20. doi: 10.1186/s12873-017-0130-9.
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。
Educational campaignの臨床試験
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The University of Texas Health Science Center,...完了