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

January 13, 2015 updated by: Licia Denti, Azienda Ospedaliero-Universitaria di Parma

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1772

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Fidenza, Italy, 43016
        • AUSL Parma
      • Modena, Italy
        • Ospedale Civile S. Agostino Estense-Baggiovara-AUSL Modena
      • Parma, Italy, 43100
        • University Hospital of Parma
      • Piacenza, Italy
        • Ospedale Guglielmo di Siliceto-AUSL Piacenza
      • Reggio Emilia, Italy
        • Arcispedale Santa Maria Nuova of Reggio Emilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Usual care
Other: Usual care
Information on stroke usually delivered at the community level.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time interval from stroke onset to arrival at the Emergency Department

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Poor outcome at 1 month
Time Frame: 1 month from stroke onset
Death or disability (modified Rankin Scale 3-6)at 1 month
1 month from stroke onset
Poor outcome at 3 months
Time Frame: 3 months from stroke onset
Death or disability (modified Rankin Scale 3-6) at 3 months
3 months from stroke onset
Rate of thrombolysis
Time Frame: Up to 4 hours and 30 minutes from stroke onset
Proportion of patients given thrombolysis
Up to 4 hours and 30 minutes from stroke onset
Rate of thrombolysis activation
Time Frame: Up to 3 hours from stroke onset
Proportion of patients evaluated for thrombolysis
Up to 3 hours from stroke onset
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
Up to 12 hours from admission at the ED
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
Up to 4 hours and 30 minutes from stroke onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria di Parma

Investigators

  • Principal Investigator: Licia Denti, MD, Parma University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 7, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRUa2-2010-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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