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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Azienda Ospedaliero-Universitaria di Parma
Sponsor:
Information provided by (Responsible Party):
Licia Denti, Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier:
NCT01881152
First received: June 7, 2013
Last updated: June 17, 2013
Last verified: June 2013

June 7, 2013
June 17, 2013
June 2013
September 2014   (final data collection date for primary outcome measure)
Percentage of early admission [ Time Frame: Time interval from stroke onset to arrival at the Emergency Department ] [ Designated as safety issue: No ]
Proportion of patients arriving to the Emergency Department with suspected stroke or TIA within two hours
Same as current
Complete list of historical versions of study NCT01881152 on ClinicalTrials.gov Archive Site
  • Poor outcome at 1 month [ Time Frame: 1 month from stroke onset ] [ Designated as safety issue: No ]
    Death or disability (modified Rankin Scale 3-6)at 1 month
  • Poor outcome at 3 months [ Time Frame: 3 months from stroke onset ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Proportion of patients given thrombolysis
  • Rate of thrombolysis activation [ Time Frame: Up to 3 hours from stroke onset ] [ Designated as safety issue: No ]
    Proportion of patients evaluated for thrombolysis
  • Delay in CT scan [ Time Frame: Up to 12 hours from admission at the ED ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time interval between arrival at the ED and thrombolysis initiation
Same as current
Not Provided
Not Provided
 
Effectiveness of a Public Campaign to Increase Stroke Awareness in Reducing Prehospital Delay
Cluster Randomized Controlled Trial to Assess the Effectiveness of a Population-based Educational Campaign on Stroke Symptom Recognition in Reducing Pre-hospital Delay

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Acute Stroke
  • Other: Educational campaign
    Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services
    Other Names:
    • Community campaign
    • Public campaign
  • Other: Usual care
    Information on stroke usually delivered at the community level.
  • Experimental: Intervention
    Educational campaign
    Intervention: Other: Educational campaign
  • Control
    Usual care
    Intervention: Other: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1800
December 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Italy
 
NCT01881152
PRUa2-2010-013
No
Licia Denti, Azienda Ospedaliero-Universitaria di Parma
Azienda Ospedaliero-Universitaria di Parma
Not Provided
Principal Investigator: Licia Denti, MD University-Hospital of Parma
Azienda Ospedaliero-Universitaria di Parma
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP