NCT02846363

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,649

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

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

September 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

1.2 years

First QC Date

July 22, 2016

Last Update Submit

July 27, 2016

Conditions

Keywords

strokepublic awareness campaigncall to EMS

Outcome Measures

Primary Outcomes (1)

  • Increase the number of calls to EMS (French call number 15) for stroke

    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.

    24 hours

Secondary Outcomes (4)

  • reduction of the time between symptoms and call to EMS for suspected stroke

    24 hours

  • increase in the number of calls to EMS for stroke within 3 hours after symptoms onset

    3 hours

  • Knowledge of the general population about stroke

    12 months

  • recognition of the need to immediately call EMS when faced with stroke suspicion

    12 months

Study Arms (2)

Patients included in the Rhône region from France

public awareness campaign

Other: public awareness campaign

Patients included in the control region (Isère, France)

Interventions

The public awareness campaign was based on improving knowledge and skills of public to recognize stroke symptoms. The campaign materials were: * 3 posters presenting the three main symptoms of stroke and the need to call the EMS immediately * A leaflet on stroke will be created * 3 participatory movies: These films will be posted on YouTube and broadcast on the website and the Facebook campaign page * Actions on social networks: A Facebook group will be created ("AVC: votre appel peut sauver des vie). * A website developed with ICAP - UCBL Lyon1 (http://avc.univ-lyon1.fr/) * On the occasion of World Stroke Day, held annually on 29 October, will be organized an event in Lyon in order to educate and inform the general public about stroke: the main symptoms and reflexes to adopt in case of stroke: call the EMS urgently

Patients included in the Rhône region from France

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute stroke suspicion patients calling the EMS of the Rhone and Isere area at the 3 periods of evaluation.

You may qualify if:

  • \- All adult patients calling EMS for suspected stroke identified by at least one symptom among face paralysis, limb paralysis or speech disorder (FAST positive)

You may not qualify if:

  • \- age below 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pôle Information Médicale, Evaluation, Recherche 162 avenue Lacassagne

Lyon, 69424, France

Location

Related Publications (1)

  • Haesebaert J, Laude C, Termoz A, Bravant E, Perreton N, Bony T, Trehard H, Porthault S, Derex L, Nighoghossian N, Schott AM. Impact of a theory-informed and user-centered stroke information campaign on the public's behaviors, attitudes, and knowledge when facing acute stroke: a controlled before-and-after study. BMC Public Health. 2020 Nov 16;20(1):1712. doi: 10.1186/s12889-020-09795-y.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Anne-Marie SCHOTT, Pr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2016

First Posted

July 27, 2016

Study Start

September 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

July 28, 2016

Record last verified: 2016-07

Locations