Effectiveness of a Public Campaign to Increase Stroke Awareness in Reducing Prehospital Delay
|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
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|