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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881152
• Other study ID #: PRUa2-2010-013
• Status: Completed
• Phase: N/A
• First received: June 7, 2013
• Last updated: January 13, 2015
• Start date: June 2013
• Est. completion date: December 2014

Study information

• 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

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Other:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Parma

Country where clinical trial is conducted

Italy, 

Outcome

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