Effectiveness of a Public Campaign to Increase Stroke Awareness in Reducing Prehospital Delay
NCT ID: NCT01881152
Last Updated: 2015-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1772 participants
INTERVENTIONAL
2013-06-30
2014-12-31
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention
Educational campaign
Educational campaign
Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services
Control
Usual care
Usual care
Information on stroke usually delivered at the community level.
Interventions
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Educational campaign
Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services
Usual care
Information on stroke usually delivered at the community level.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* No informed consent from patient or caregiver
18 Years
ALL
No
Sponsors
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Azienda Ospedaliero-Universitaria di Parma
OTHER
Responsible Party
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Licia Denti
Medical Doctor
Principal Investigators
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Licia Denti, MD
Role: PRINCIPAL_INVESTIGATOR
Parma University Hospital
Locations
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AUSL Parma
Fidenza, , Italy
Ospedale Civile S. Agostino Estense-Baggiovara-AUSL Modena
Modena, , Italy
University Hospital of Parma
Parma, , Italy
Ospedale Guglielmo di Siliceto-AUSL Piacenza
Piacenza, , Italy
Arcispedale Santa Maria Nuova of Reggio Emilia
Reggio Emilia, , Italy
Countries
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References
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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.
Other Identifiers
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PRUa2-2010-013
Identifier Type: -
Identifier Source: org_study_id
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