NCT01881152

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,772

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

1.5 years

First QC Date

June 7, 2013

Last Update Submit

January 13, 2015

Conditions

Acute Stroke

Keywords

StrokeCommunity educationAwarenessPrehospital delay

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Poor outcome at 1 month

    1 month from stroke onset

  • Poor outcome at 3 months

    3 months from stroke onset

  • Rate of thrombolysis

    Up to 4 hours and 30 minutes from stroke onset

  • Rate of thrombolysis activation

    Up to 3 hours from stroke onset

  • Delay in CT scan

    Up to 12 hours from admission at the ED

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Educational campaign

Other: Educational campaign

Control

OTHER

Usual care

Other: Usual care

Interventions

Educational campaignOTHER

Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services

Also known as: Community campaign, Public campaign
Intervention
Usual careOTHER

Information on stroke usually delivered at the community level.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • No information available on the time of stroke onset.
  • No informed consent from patient or caregiver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

AUSL Parma

Fidenza, 43016, Italy

Location

Ospedale Civile S. Agostino Estense-Baggiovara-AUSL Modena

Modena, Italy

Location

University Hospital of Parma

Parma, 43100, Italy

Location

Ospedale Guglielmo di Siliceto-AUSL Piacenza

Piacenza, Italy

Location

Arcispedale Santa Maria Nuova of Reggio Emilia

Reggio Emilia, Italy

Location

Related Publications (2)

  • 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.

    PMID: 29101258DERIVED

  • 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.

    PMID: 28646851DERIVED

MeSH Terms

Conditions

StrokeHealth Education

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Licia Denti, MD

    Parma University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 7, 2013

First Posted

June 19, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

IT(5)