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出境医 / 临床实验 / Involvement of the Physician in Primary Prevention and Pre-hospital Management of Stroke (PREVENTION AVC)

Involvement of the Physician in Primary Prevention and Pre-hospital Management of Stroke (PREVENTION AVC)

Study Description
Brief 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. 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

Condition or disease Intervention/treatment
Stroke Other: Patients With Stroke

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Involvement of the Physician in Primary Prevention and Pre-hospital Management of Stroke
Actual Study Start Date : June 7, 2019
Actual Primary Completion Date : July 29, 2019
Actual Study Completion Date : December 5, 2019
Arms and Interventions
Group/Cohort Intervention/treatment
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.
 Other: 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.
Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Study the different effective means of primary prevention [ Time Frame: Day 1 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient hospitalized in the neurology / neurovascular department within the GHPSJ following a stroke (first episode or recurrence)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations

Locations
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France
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
Layout table for investigator information
Principal Investigator: Marie BRUANDET, MD Groupe Hospitalier Paris Saint Joseph
Tracking Information
First Submitted Date May 24, 2019
First Posted Date June 5, 2019
Last Update Posted Date December 6, 2019
Actual Study Start Date June 7, 2019
Actual Primary Completion Date July 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2019) 		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.
Original Primary Outcome Measures
 (submitted: June 3, 2019) 		Delay between Stroke's symptoms and care in the hospital. [ 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.
Change History
Current Secondary Outcome Measures
 (submitted: June 3, 2019) 		Study the different effective means of primary prevention [ Time Frame: Day 1 ]
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Involvement of the Physician in Primary Prevention and Pre-hospital Management of Stroke
Official Title Involvement of the Physician in Primary Prevention and Pre-hospital Management of Stroke
Brief 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. 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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient hospitalized in the neurology / neurovascular department within the GHPSJ following a stroke (first episode or recurrence)
Condition Stroke
Intervention Other: 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.
Study Groups/Cohorts 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.
Intervention: Other: Patients With Stroke
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 5, 2019) 		18
Original Estimated Enrollment
 (submitted: June 3, 2019) 		200
Actual Study Completion Date December 5, 2019
Actual Primary Completion Date July 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03975218
Other Study ID Numbers PREVENTION AVC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Groupe Hospitalier Paris Saint Joseph
Study Sponsor Groupe Hospitalier Paris Saint Joseph
Collaborators Not Provided
Investigators
Principal Investigator: Marie BRUANDET, MD Groupe Hospitalier Paris Saint Joseph
PRS Account Groupe Hospitalier Paris Saint Joseph
Verification Date December 2019

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