- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02846363
REACT AGAINST STROKE (AVC - REACT)
Acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. In a previous exhaustive cohort study conducted in the Rhône region, France (AVC69) the investigators observed that only a small percentage of patients could access to thrombolysis in time. In this cohort of 1306 patients treated in one of the emergency department of the Rhone region for a suspected stroke, 84% of patients reached hospital through an emergency department instead of going directly to a stroke unit. Among those patients, only 8% were finally thrombolysed, because of extended management times.. Our hypothesis was that public awareness campaign designed to improve public's knowledge and skills would consequently reduce prehospital time and favour call to prehospital emergency medical services (EMS).
The investigators will conduct an awareness campaign aimed at the general population, using different communication media, the content will be developed based on the results of a qualitative study with focus groups (Quali-AVC), and using a diffusion plan established with communications professionals. To assess the effects of this campaign, a comparative quasi-experimental before-after study will be conducted. A control region where no awareness stroke program has been set up has been selected, data will be collected in the two regions. The assessment of the impact of the campaign will focus on the comparison of the evolution of indicators between these two regions. Three assessment time will be provided: before starting the program, at 3 months and at the end of the program.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lyon, France, 69424
- Pôle Information Médicale, Evaluation, Recherche 162 avenue Lacassagne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All adult patients calling EMS for suspected stroke identified by at least one symptom among face paralysis, limb paralysis or speech disorder (FAST positive)
Exclusion Criteria:
- age below 18
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients included in the Rhône region from France
public awareness campaign
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The public awareness campaign was based on improving knowledge and skills of public to recognize stroke symptoms. The campaign materials were:
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Patients included in the control region (Isère, France)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Increase the number of calls to EMS (French call number 15) for stroke
Time Frame: 24 hours
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Comparison between the two regions of the changing number of calls to EMS for suspected stroke between 1 month before the start of campaign and 12 months after campaign.
Calls to EMS for suspicion of stroke will be collected over a period of 60 consecutive days at each assessment period.
Suspicion of stroke will be defined as the presence of a positive test FAST, which mean at least one of the three symptoms: Face, Arm or Speech disability, identified by phone by the EMS triage officer or emergency physician.
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24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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reduction of the time between symptoms and call to EMS for suspected stroke
Time Frame: 24 hours
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Comparison between the two regions of changes between 1 month before the start of campaign and 12 months after campaign of the time between the onset of symptoms and the call to EMS for suspected stroke.
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24 hours
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increase in the number of calls to EMS for stroke within 3 hours after symptoms onset
Time Frame: 3 hours
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Comparison between the two regions of the changing proportion of calls to EMS for suspected stroke within 3 hours between 1 month before the start of campaign and 12 months after campaign.
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3 hours
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Knowledge of the general population about stroke
Time Frame: 12 months
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Comparison between two regions of changes between 1 month before the start of campaign and 12 months after campaign in the proportion of respondents who know the 3 main symptoms of stroke (facial paralysis, limb paralysis and speech impaired)
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12 months
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recognition of the need to immediately call EMS when faced with stroke suspicion
Time Frame: 12 months
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Comparison between two regions of changes between 1 month before the start of campaign and 12 months after campaign in the proportion of respondents saying that the most appropriate response to a person having a stroke is to call the EMS without delay.
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne-Marie Schott, Pr, Hospices Civils de Lyon
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D21999
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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