StrokePREVENTION AVCNCT03975218
Involvement of the Physician in Primary Prevention and Pre-hospital Management of Stroke
An observational study of Stroke, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Stroke is a growing disease. It is the first pathology responsible for acquired handicap, the second of dementia and the second cause of death in the world. In France, they are the leading cause of death in women and the third cause in men. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Patients With Stroke
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2019to 5 Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient hospitalized in the neurology / neurovascular department within the GHPSJ following a stroke (first episode or recurrence)
Who may be able to join
- Patient whose age is ≥ 18 years
- Patient hospitalized in the neurology / neurovascular department within the GHPSJ following a stroke (first episode or recurrence)
- Francophone patient
Who cannot join
- Patient with previously labeled cognitive impairment
- Patient under tutorship or curatorship
- Patient deprived of liberty
- Patient unable to answer the questionnaire
- Patient opposing participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Stroke is a growing disease. It is the first pathology responsible for acquired handicap, the second of dementia and the second cause of death in the world. In France, they are the leading cause of death in women and the third cause in men. Sequelae and disabilities also represent a significant financial cost for health insurance.
The early management of the treatment improves the patient's vital and functional prognosis. The ability of the patient to identify the signs of stroke requiring urgent consultation and proper orientation are therefore crucial for further management.
Read more
The most common signs that patients must recognize are muscle weakness or sudden paralysis of an arm, leg or half of the body, asymmetry of the face, tingling, numbness of a hemi-body, speech or understanding, loss of vision of an eye or hemifield, disorder of the coordination of a hemi-body. The variety of clinical pictures complicates primary prevention.
In this context, a 2010-2014 National Stroke Action Plan was undertaken with the aim, among other things, of developing information to prevent stroke and to limit its sequelae. In this plan, the attending physician must improve prevention in high-risk patients and be a link between the city and the hospital for follow-up.
Several questions arise:
- Are patients who are regularly followed by a general practitioner better educated on the signs of stroke / TIA and thus more able to give an appropriate warning?
- What is the profile of patients who have not been affected by the different modes of primary prevention?
- What are the effective means of information and those desired
- Conditions
- Stroke
- Being tested
- Patients With Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients With StrokeOther
In addition to the usual care, the patient will have to complete a questionnaire analyzing the regularity of his follow-up by a physician.
| Study group | Role | What they receive |
|---|---|---|
| Patients with stroke | In addition to the usual care, the patient will have to complete a questionnaire analyzing the regularity of his follow-up by a physician. Receives: Other: Patients With Stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until patient's care in the hospital after stroke's symptoms
The delay between the observation of signs of stroke and specialized neurovascular management at the hospital will be measured. This measures the impact of physician's prevention on the management of stroke.
Measured: Day 1
Secondary outcomes (1)
Study the different effective means of primary prevention
Patient questionnaire corresponds to open question about physician in primary prevention and pre-hospital management of stroke to which the patient will respond yes or no.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start7 Jun 2019
- Primary completion29 Jul 2019
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie BRUANDET, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975218
- Sponsor's protocol ID
- PREVENTION AVC
- Acronym
- PREVENTION AVC
- Status last verified
- Dec 2019
- First submitted
- 24 May 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of the Physician in Primary Prevention and Pre-hospital Management of Stroke
- ClinicalTrials.gov ID
- NCT03975218
- Acronym / sponsor ID
- PREVENTION AVC / PREVENTION AVC
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 5 Jun 2019 (actual)
- 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.
Stroke is a growing disease. It is the first pathology responsible for acquired handicap, the second of dementia and the second cause of death in the world. In France, they are the leading cause of death in women and the third cause in men. Sequelae and disabilities also represent a significant financial cost for health insurance.
The early management of the treatment improves the patient's vital and functional prognosis. The ability of the patient to identify the signs of stroke requiring urgent consultation and proper orientation are therefore crucial for further management.
The most common signs that patients must recognize are muscle weakness or sudden paralysis of an arm, leg or half of the body, asymmetry of the face, tingling, numbness of a hemi-body, speech or understanding, loss of vision of an eye or hemifield, disorder of the coordination of a hemi-body. The variety of clinical pictures complicates primary prevention.
In this context, a 2010-2014 National Stroke Action Plan was undertaken with the aim, among other things, of developing information to prevent stroke and to limit its sequelae. In this plan, the attending physician must improve prevention in high-risk patients and be a link between the city and the hospital for follow-up.
Several questions arise:
- Are patients who are regularly followed by a general practitioner better educated on the signs of stroke / TIA and thus more able to give an appropriate warning?
- What is the profile of patients who have not been affected by the different modes of primary prevention?
- What are the effective means of information and those desired
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with stroke | – | Other: Patients With StrokeIn addition to the usual care, the patient will have to complete a questionnaire analyzing the regularity of his follow-up by a physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient hospitalized in the neurology / neurovascular department within the GHPSJ following a stroke (first episode or recurrence)
Key inclusion criteria (3 listed)
- Patient whose age is ≥ 18 years
- Patient hospitalized in the neurology / neurovascular department within the GHPSJ following a stroke (first episode or recurrence)
- Francophone patient
Key exclusion criteria (5 listed)
- Patient with previously labeled cognitive impairment
- Patient under tutorship or curatorship
- Patient deprived of liberty
- Patient unable to answer the questionnaire
- Patient opposing participation in the study
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 |
|---|---|---|
| Patients With StrokeIn addition to the usual care, the patient will have to complete a questionnaire analyzing the regularity of his follow-up by a physician. | Other | Patients with stroke |
Primary outcome
Time until patient's care in the hospital after stroke's symptoms
Time frame: Day 1
The delay between the observation of signs of stroke and specialized neurovascular management at the hospital will be measured. This measures the impact of physician's prevention on the management of stroke.
1 secondary outcome
Study the different effective means of primary prevention
Time frame: Day 1
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 6 Dec 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Marie BRUANDET, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Fondation Hôpital Saint-Joseph 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 3 inclusion and 5 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 6 Dec 2019. 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?
Time until patient's care in the hospital after stroke's symptoms (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2019.