Effectiveness of a Public Campaign to Increase Stroke Awareness in Reducing Prehospital Delay
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|ClinicalTrials.gov Identifier: NCT01881152|
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : January 14, 2015
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).
|Condition or disease||Intervention/treatment||Phase|
|Acute Stroke||Other: Educational campaign Other: Usual care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1772 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cluster Randomized Controlled Trial to Assess the Effectiveness of a Population-based Educational Campaign on Stroke Symptom Recognition in Reducing Pre-hospital Delay|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Other: Educational campaign
Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services
Other: Usual care
Information on stroke usually delivered at the community level.
- Percentage of early admission [ Time Frame: Time interval from stroke onset to arrival at the Emergency Department ]Proportion of patients arriving to the Emergency Department with suspected stroke or TIA within two hours
- Poor outcome at 1 month [ Time Frame: 1 month from stroke onset ]Death or disability (modified Rankin Scale 3-6)at 1 month
- Poor outcome at 3 months [ Time Frame: 3 months from stroke onset ]Death or disability (modified Rankin Scale 3-6) at 3 months
- Rate of thrombolysis [ Time Frame: Up to 4 hours and 30 minutes from stroke onset ]Proportion of patients given thrombolysis
- Rate of thrombolysis activation [ Time Frame: Up to 3 hours from stroke onset ]Proportion of patients evaluated for thrombolysis
- Delay in CT scan [ Time Frame: Up to 12 hours from admission at the ED ]Time interval between arrival at the Emergency Department and CT scan
- Door to needle time [ Time Frame: Up to 4 hours and 30 minutes from stroke onset ]Time interval between arrival at the ED and thrombolysis initiation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881152
|Fidenza, Italy, 43016|
|Ospedale Civile S. Agostino Estense-Baggiovara-AUSL Modena|
|University Hospital of Parma|
|Parma, Italy, 43100|
|Ospedale Guglielmo di Siliceto-AUSL Piacenza|
|Arcispedale Santa Maria Nuova of Reggio Emilia|
|Reggio Emilia, Italy|
|Principal Investigator:||Licia Denti, MD||University Hospitals Parma Medical Center|