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

Primary Purpose

Acute Stroke

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Educational campaign
Usual care
Sponsored by
Azienda Ospedaliero-Universitaria di Parma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Stroke focused on measuring Stroke, Community education, Awareness, Prehospital delay

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Control

Arm Description

Educational campaign

Usual care

Outcomes

Primary Outcome Measures

Percentage of early admission
Proportion of patients arriving to the Emergency Department with suspected stroke or TIA within two hours

Secondary Outcome Measures

Poor outcome at 1 month
Death or disability (modified Rankin Scale 3-6)at 1 month
Poor outcome at 3 months
Death or disability (modified Rankin Scale 3-6) at 3 months
Rate of thrombolysis
Proportion of patients given thrombolysis
Rate of thrombolysis activation
Proportion of patients evaluated for thrombolysis
Delay in CT scan
Time interval between arrival at the Emergency Department and CT scan
Door to needle time
Time interval between arrival at the ED and thrombolysis initiation

Full Information

First Posted
June 7, 2013
Last Updated
January 13, 2015
Sponsor
Azienda Ospedaliero-Universitaria di Parma
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1. Study Identification

Unique Protocol Identification Number
NCT01881152
Brief Title
Effectiveness of a Public Campaign to Increase Stroke Awareness in Reducing Prehospital Delay
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 Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria di Parma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
Stroke, Community education, Awareness, Prehospital delay

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1772 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Educational campaign
Arm Title
Control
Arm Type
Other
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Educational campaign
Other Intervention Name(s)
Community campaign, Public campaign
Intervention Description
Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Information on stroke usually delivered at the community level.
Primary Outcome Measure Information:
Title
Percentage of early admission
Description
Proportion of patients arriving to the Emergency Department with suspected stroke or TIA within two hours
Time Frame
Time interval from stroke onset to arrival at the Emergency Department
Secondary Outcome Measure Information:
Title
Poor outcome at 1 month
Description
Death or disability (modified Rankin Scale 3-6)at 1 month
Time Frame
1 month from stroke onset
Title
Poor outcome at 3 months
Description
Death or disability (modified Rankin Scale 3-6) at 3 months
Time Frame
3 months from stroke onset
Title
Rate of thrombolysis
Description
Proportion of patients given thrombolysis
Time Frame
Up to 4 hours and 30 minutes from stroke onset
Title
Rate of thrombolysis activation
Description
Proportion of patients evaluated for thrombolysis
Time Frame
Up to 3 hours from stroke onset
Title
Delay in CT scan
Description
Time interval between arrival at the Emergency Department and CT scan
Time Frame
Up to 12 hours from admission at the ED
Title
Door to needle time
Description
Time interval between arrival at the ED and thrombolysis initiation
Time Frame
Up to 4 hours and 30 minutes from stroke onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Licia Denti, MD
Organizational Affiliation
Parma University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AUSL Parma
City
Fidenza
ZIP/Postal Code
43016
Country
Italy
Facility Name
Ospedale Civile S. Agostino Estense-Baggiovara-AUSL Modena
City
Modena
Country
Italy
Facility Name
University Hospital of Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Ospedale Guglielmo di Siliceto-AUSL Piacenza
City
Piacenza
Country
Italy
Facility Name
Arcispedale Santa Maria Nuova of Reggio Emilia
City
Reggio Emilia
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
29101258
Citation
Denti L, Caminiti C, Scoditti U, Zini A, Malferrari G, Zedde ML, Guidetti D, Baratti M, Vaghi L, Montanari E, Marcomini B, Riva S, Iezzi E, Castellini P, Olivato S, Barbi F, Perticaroli E, Monaco D, Iafelice I, Bigliardi G, Vandelli L, Guareschi A, Artoni A, Zanferrari C, Schulz PJ. Impact on Prehospital Delay of a Stroke Preparedness Campaign: A SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial). Stroke. 2017 Dec;48(12):3316-3322. doi: 10.1161/STROKEAHA.117.018135. Epub 2017 Nov 3.
Results Reference
derived
PubMed Identifier
28646851
Citation
Caminiti C, Schulz P, Marcomini B, Iezzi E, Riva S, Scoditti U, Zini A, Malferrari G, Zedde ML, Guidetti D, Montanari E, Baratti M, Denti L; Educazione e Ritardo di Ospedalizzazione (E.R.O.I) study group. Development of an education campaign to reduce delays in pre-hospital response to stroke. BMC Emerg Med. 2017 Jun 24;17(1):20. doi: 10.1186/s12873-017-0130-9.
Results Reference
derived

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

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