StrokeAVC - REACTNCT02846363
REACT AGAINST STROKE
An observational study of Stroke, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- public awareness campaign
- How many people
- 2,649 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Acute stroke suspicion patients calling the EMS of the Rhone and Isere area at the 3 periods of evaluation.
Who may be able to join
- All adult patients calling EMS for suspected stroke identified by at least one symptom among face paralysis, limb paralysis or speech disorder (FAST positive)
Who cannot join
- age below 18
Trial locations and contacts
1 site in 1 country.
France1 site
Pôle Information Médicale, Evaluation, Recherche 162 avenue Lacassagne
Lyon, 69424
About this study
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.
- Conditions
- Stroke
- Being tested
- public awareness campaign
- Keywords
- stroke, public awareness campaign, call to EMS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
public awareness campaignOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patients included in the Rhône region from France | public awareness campaign Receives: Other: public awareness campaign | |
| Patients included in the control region (Isère, France) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (4)
reduction of the time between symptoms and call to EMS for suspected stroke
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.
Measured: 24 hours
increase in the number of calls to EMS for stroke within 3 hours after symptoms onset
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.
Measured: 3 hours
Knowledge of the general population about stroke
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)
Measured: 12 months
recognition of the need to immediately call EMS when faced with stroke suspicion
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startSep 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,649 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Marie SCHOTT, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846363
- Sponsor's protocol ID
- D21999
- Acronym
- AVC - REACT
- Status last verified
- Jul 2016
- First submitted
- 22 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33198689
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REACT AGAINST STROKE
- ClinicalTrials.gov ID
- NCT02846363
- Acronym / sponsor ID
- AVC - REACT / D21999
- Conditions
- Stroke
- Keywords
- stroke, public awareness campaign, call to EMS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,649 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients included in the Rhône region from France | – | Other: public awareness campaignpublic awareness campaign |
| Patients included in the control region (Isère, France) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Acute stroke suspicion patients calling the EMS of the Rhone and Isere area at the 3 periods of evaluation.
Key inclusion criteria (1 listed)
- All adult patients calling EMS for suspected stroke identified by at least one symptom among face paralysis, limb paralysis or speech disorder (FAST positive)
Key exclusion criteria (1 listed)
- age below 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| public awareness campaignThe 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 | Other | Patients included in the Rhône region from France |
Primary outcome
Increase the number of calls to EMS (French call number 15) for stroke
Time frame: 24 hours
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.
4 secondary outcomes
reduction of the time between symptoms and call to EMS for suspected stroke
Time frame: 24 hours
increase in the number of calls to EMS for stroke within 3 hours after symptoms onset
Time frame: 3 hours
Knowledge of the general population about stroke
Time frame: 12 months
recognition of the need to immediately call EMS when faced with stroke suspicion
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Derived from this study: PubMed 33198689Haesebaert 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.
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Marie SCHOTT, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase the number of calls to EMS (French call number 15) for stroke (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02846363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.