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

NCT ID: NCT01881152

Last Updated: 2015-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1772 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Acute Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Educational campaign

Group Type EXPERIMENTAL

Educational campaign

Intervention Type OTHER

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

Control

Usual care

Group Type OTHER

Usual care

Intervention Type OTHER

Information on stroke usually delivered at the community level.

Interventions

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Educational campaign

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

Intervention Type OTHER

Usual care

Information on stroke usually delivered at the community level.

Intervention Type OTHER

Other Intervention Names

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Community campaign Public campaign

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria di Parma

OTHER

Sponsor Role lead

Responsible Party

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Licia Denti

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Licia Denti, MD

Role: PRINCIPAL_INVESTIGATOR

Parma University Hospital

Locations

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AUSL Parma

Fidenza, , Italy

Site Status

Ospedale Civile S. Agostino Estense-Baggiovara-AUSL Modena

Modena, , Italy

Site Status

University Hospital of Parma

Parma, , Italy

Site Status

Ospedale Guglielmo di Siliceto-AUSL Piacenza

Piacenza, , Italy

Site Status

Arcispedale Santa Maria Nuova of Reggio Emilia

Reggio Emilia, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 29101258 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28646851 (View on PubMed)

Other Identifiers

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PRUa2-2010-013

Identifier Type: -

Identifier Source: org_study_id

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