Acute Stroke Clinical Trial
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
Verified date | January 2015 |
Source | Azienda Ospedaliero-Universitaria di Parma |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 1772 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Italy | 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 |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria di Parma |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of early admission | Proportion of patients arriving to the Emergency Department with suspected stroke or TIA within two hours | Time interval from stroke onset to arrival at the Emergency Department | No |
Secondary | Poor outcome at 1 month | Death or disability (modified Rankin Scale 3-6)at 1 month | 1 month from stroke onset | No |
Secondary | Poor outcome at 3 months | Death or disability (modified Rankin Scale 3-6) at 3 months | 3 months from stroke onset | No |
Secondary | Rate of thrombolysis | Proportion of patients given thrombolysis | Up to 4 hours and 30 minutes from stroke onset | No |
Secondary | Rate of thrombolysis activation | Proportion of patients evaluated for thrombolysis | Up to 3 hours from stroke onset | No |
Secondary | Delay in CT scan | Time interval between arrival at the Emergency Department and CT scan | Up to 12 hours from admission at the ED | No |
Secondary | Door to needle time | Time interval between arrival at the ED and thrombolysis initiation | Up to 4 hours and 30 minutes from stroke onset | No |
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