Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-03 @ 11:15 AM
Study NCT ID:
NCT03975218
Status:
COMPLETED
Last Update Posted:
2019-12-06
First Post:
2019-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Involvement of the Physician in Primary Prevention and Pre-hospital Management of Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-05', 'studyFirstSubmitDate': '2019-05-24', 'studyFirstSubmitQcDate': '2019-06-03', 'lastUpdatePostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Time until patient's care in the hospital after stroke's symptoms", 'timeFrame': 'Day 1', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Study the different effective means of primary prevention', 'timeFrame': 'Day 1', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nThe 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.\n\nIn 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.\n\nSeveral questions arise:\n\n* 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?\n* What is the profile of patients who have not been affected by the different modes of primary prevention?\n* What are the effective means of information and those desired"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient hospitalized in the neurology / neurovascular department within the GHPSJ following a stroke (first episode or recurrence)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient whose age is ≥ 18 years\n* Patient hospitalized in the neurology / neurovascular department within the GHPSJ following a stroke (first episode or recurrence)\n* Francophone patient\n\nExclusion Criteria:\n\n* Patient with previously labeled cognitive impairment\n* Patient under tutorship or curatorship\n* Patient deprived of liberty\n* Patient unable to answer the questionnaire\n* Patient opposing participation in the study'}, 'identificationModule': {'nctId': 'NCT03975218', 'acronym': 'PREVENTION AVC', 'briefTitle': 'Involvement of the Physician in Primary Prevention and Pre-hospital Management of Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Involvement of the Physician in Primary Prevention and Pre-hospital Management of Stroke', 'orgStudyIdInfo': {'id': 'PREVENTION AVC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with stroke', 'description': 'In addition to the usual care, the patient will have to complete a questionnaire analyzing the regularity of his follow-up by a physician.', 'interventionNames': ['Other: Patients With Stroke']}], 'interventions': [{'name': 'Patients With Stroke', 'type': 'OTHER', 'description': 'In addition to the usual care, the patient will have to complete a questionnaire analyzing the regularity of his follow-up by a physician.', 'armGroupLabels': ['Patients with stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Paris Saint-Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Marie BRUANDET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Hôpital Saint-Joseph'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}