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
  Purpose

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 Intervention
Acute Stroke
Other: Educational campaign
Other: Usual care

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

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliero-Universitaria di Parma:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1800
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Educational campaign
Other: Educational campaign
Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services
Other Names:
  • Community campaign
  • Public campaign
Control
Usual care
Other: Usual care
Information on stroke usually delivered at the community level.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881152

Locations
Italy
AUSL Parma Recruiting
Fidenza, Italy, 43016
Contact: Enrico Montanari, MD       emontanari@ausl.pr.it   
Principal Investigator: Enrico Montanari, MD         
Ospedale Civile S. Agostino Estense-Baggiovara-AUSL Modena Recruiting
Modena, Italy
Contact: Andrea Zini, MD       a.zini@ausl.mo.it   
Principal Investigator: Andrea Zini, MD         
University Hospital of Parma Recruiting
Parma, Italy, 43100
Contact: Licia Denti, MD    +390521704727    ldenti@ao.pr.it   
Sub-Investigator: Umberto Scoditti, MD         
Ospedale Guglielmo di Siliceto-AUSL Piacenza Recruiting
Piacenza, Italy
Contact: Donata Guidetti, MD       D.Guidetti@ausl.pc.it   
Principal Investigator: Donata Guidetti         
Arcispedale Santa Maria Nuova of Reggio Emilia Recruiting
Reggio Emilia, Italy
Contact: Giovanni Malferrari, MD       Giovanni.Malferrari@asmn.re.it   
Principal Investigator: Giovanni malferrari, MD         
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Parma
Investigators
Principal Investigator: Licia Denti, MD University-Hospital of Parma
  More Information

No publications provided

Responsible Party: Licia Denti, Medical Doctor, Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier: NCT01881152     History of Changes
Other Study ID Numbers: PRUa2-2010-013
Study First Received: June 7, 2013
Last Updated: June 17, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliero-Universitaria di Parma:
Stroke
Community education
Awareness
Prehospital delay

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 18, 2014