Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2026-01-04 @ 8:46 AM
Study NCT ID:
NCT02346266
Status:
UNKNOWN
Last Update Posted:
2015-01-26
First Post:
2015-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMART (School-aged Children Making Healthy Choices And Recognizing 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-23', 'studyFirstSubmitDate': '2015-01-20', 'studyFirstSubmitQcDate': '2015-01-23', 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child Improved Stroke Literacy', 'timeFrame': '3 weeks', 'description': 'A school-based stroke literacy program targeting children in grades 9th through 12th will be successful in improving stroke literacy.'}], 'secondaryOutcomes': [{'measure': 'Adult Improved Stroke Literacy', 'timeFrame': '3 weeks', 'description': 'If school-aged children, grades 9th through 12th are taught the F.A.S.T. acronym, additional signs and symptoms of stroke and the immediate activation of EMS by calling 911, they will improve the stroke literacy of their parents.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'Stroke Prevention', 'Children', 'Education'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'A stroke awareness program for school-aged children to learn the signs/symptoms of stroke, teach their parents and make healthy life-style choices.', 'detailedDescription': "1. To educate school-aged children, grades 9th through 12th on the F.A.S.T. (Face, Arm, Speech and Time) acronym, additional signs and symptoms of stroke and the need for immediate activation of Emergency Medical Services (EMS) by calling 911.\n2. To improve adults' stroke literacy through educating their children in grades 9th through 12th."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High-school student\n\nExclusion Criteria:\n\n* Not a high-school student'}, 'identificationModule': {'nctId': 'NCT02346266', 'acronym': 'SMART', 'briefTitle': 'SMART (School-aged Children Making Healthy Choices And Recognizing sTroke)', 'organization': {'class': 'OTHER', 'fullName': 'Los Amigos Research and Education Institute'}, 'officialTitle': 'SMART (School-aged Children Making Healthy Choices And Recognizing sTroke): A Pilot Trial of a Stroke Awareness Program', 'orgStudyIdInfo': {'id': '176'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SMART', 'description': 'The intervention group of school-aged children will receive education on the F.A.S.T. (Face, Arm, Speech and Time) acronym, additional signs and symptoms of stroke and the need for immediate activation of Emergency Medical Services (EMS) by calling 911.', 'interventionNames': ['Other: SMART Education']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'This group will not receive stroke education.'}], 'interventions': [{'name': 'SMART Education', 'type': 'OTHER', 'armGroupLabels': ['SMART']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Los Amigos Research and Education Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}