Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-10 @ 2:51 PM
Study NCT ID:
NCT03831451
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2019-01-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stroke Ready: A Stroke Preparedness Brief Intervention
Sponsor:
Organization:
Raw JSON
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It will be delivered in-person by a research team member. The intervention focuses on recognizing stroke symptoms and the importance of calling 911.\n\nStroke preparedness intervention: Face-to-face interaction with research staff lasting between 5-10 minutes', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Lifestyle Intervention', 'description': 'The Healthy lifestyle stroke risk reduction educational intervention is based on patient materials from the American Heart Association. It will be delivered in-person by a research team member. The intervention focuses on stroke risk reduction.\n\nHealthy lifestyle stroke risk reduction intervention: Face-to-face interaction with research staff lasting between 5-10 minutes', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Behavioral Intent to Call 911', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stroke Preparedness Intervention', 'description': 'The stroke preparedness educational intervention was designed with input from the community where it is being tested. It will be delivered in-person by a research team member. The intervention focuses on recognizing stroke symptoms and the importance of calling 911.\n\nStroke preparedness intervention: Face-to-face interaction with research staff lasting between 5-10 minutes'}, {'id': 'OG001', 'title': 'Healthy Lifestyle Intervention', 'description': 'The Healthy lifestyle stroke risk reduction educational intervention is based on patient materials from the American Heart Association. It will be delivered in-person by a research team member. The intervention focuses on stroke risk reduction.\n\nHealthy lifestyle stroke risk reduction intervention: Face-to-face interaction with research staff lasting between 5-10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately (up to 10 minutes) before the brief intervention and then immediately (up to 10 minutes) after completing the brief intervention', 'description': 'Change in Behavioral intent to call 911 using a self-administered survey. The survey is the Stroke Action test which was modified based on community input. Scores range from 0-12 for stroke. A higher score means greater stroke behavioral intent to call 911 for a stroke while a low score means lower behavioral intent to call 911 for a stroke.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean changes from pre-intervention to post-intervention'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stroke Preparedness Intervention', 'description': 'The stroke preparedness educational intervention was designed with input from the community where it is being tested. It will be delivered in-person by a research team member. The intervention focuses on recognizing stroke symptoms and the importance of calling 911.\n\nStroke preparedness intervention: Face-to-face interaction with research staff lasting between 5-10 minutes'}, {'id': 'FG001', 'title': 'Healthy Lifestyle Intervention', 'description': 'The Healthy lifestyle stroke risk reduction educational intervention is based on patient materials from the American Heart Association. It will be delivered in-person by a research team member. The intervention focuses on stroke risk reduction.\n\nHealthy lifestyle stroke risk reduction intervention: Face-to-face interaction with research staff lasting between 5-10 minutes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Stroke Preparedness Intervention', 'description': 'The stroke preparedness educational intervention was designed with input from the community where it is being tested. It will be delivered in-person by a research team member. The intervention focuses on recognizing stroke symptoms and the importance of calling 911.\n\nStroke preparedness intervention: Face-to-face interaction with research staff lasting between 5-10 minutes'}, {'id': 'BG001', 'title': 'Healthy Lifestyle Intervention', 'description': 'The Healthy lifestyle stroke risk reduction educational intervention is based on patient materials from the American Heart Association. It will be delivered in-person by a research team member. The intervention focuses on stroke risk reduction.\n\nHealthy lifestyle stroke risk reduction intervention: Face-to-face interaction with research staff lasting between 5-10 minutes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '13', 'groupId': 'BG000'}, {'value': '61', 'spread': '15', 'groupId': 'BG001'}, {'value': '61', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-10', 'size': 1266448, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-01T11:49', 'hasProtocol': True}, {'date': '2019-01-10', 'size': 744378, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-11-01T12:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Subjects will be randomized to a brief face-to-face stroke preparedness intervention compared to a healthy lifestyle stroke risk reduction intervention. After completing the outcome assessment, subjects will have the opportunity to receive the intervention that they were not initially randomized too.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-01', 'studyFirstSubmitDate': '2019-01-24', 'resultsFirstSubmitDate': '2019-09-04', 'studyFirstSubmitQcDate': '2019-02-03', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-01', 'studyFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Behavioral Intent to Call 911', 'timeFrame': 'Immediately (up to 10 minutes) before the brief intervention and then immediately (up to 10 minutes) after completing the brief intervention', 'description': 'Change in Behavioral intent to call 911 using a self-administered survey. The survey is the Stroke Action test which was modified based on community input. Scores range from 0-12 for stroke. A higher score means greater stroke behavioral intent to call 911 for a stroke while a low score means lower behavioral intent to call 911 for a stroke.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke preparedness', 'behavioral intervention'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '33238728', 'type': 'DERIVED', 'citation': 'Robles MC, Springer MV, Corches CL, Burke JF, Lin CC, Oliver A, Skolarus LE. Stroke Ready Very Brief Intervention Improves Immediate Postintervention Stroke Preparedness. Circ Cardiovasc Qual Outcomes. 2020 Dec;13(12):e006643. doi: 10.1161/CIRCOUTCOMES.120.006643. Epub 2020 Nov 26. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled behavioral intervention trial to assess the efficacy of a brief intervention to increase stroke preparedness.', 'detailedDescription': 'This is a randomized controlled behavioral intervention trial to assess the efficacy of a brief intervention to increase stroke preparedness. Subjects will be randomized to a brief face-to-face stroke preparedness intervention compared to a healthy lifestyle stroke risk reduction intervention. The primary outcome is behavioral intent to call 911 using a self-administered survey'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years of age\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03831451', 'briefTitle': 'Stroke Ready: A Stroke Preparedness Brief Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Stroke Ready: A Stroke Preparedness Brief Intervention', 'orgStudyIdInfo': {'id': 'U01MD010579-substudy'}, 'secondaryIdInfos': [{'id': 'U01MD010579', 'link': 'https://reporter.nih.gov/quickSearch/U01MD010579', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stroke Preparedness Intervention', 'description': 'The stroke preparedness educational intervention was designed with input from the community where it is being tested. It will be delivered in-person by a research team member. The intervention focuses on recognizing stroke symptoms and the importance of calling 911.', 'interventionNames': ['Behavioral: Stroke preparedness intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy lifestyle intervention', 'description': 'The Healthy lifestyle stroke risk reduction educational intervention is based on patient materials from the American Heart Association. It will be delivered in-person by a research team member. The intervention focuses on stroke risk reduction.', 'interventionNames': ['Behavioral: Healthy lifestyle stroke risk reduction intervention']}], 'interventions': [{'name': 'Stroke preparedness intervention', 'type': 'BEHAVIORAL', 'description': 'Face-to-face interaction with research staff lasting between 5-10 minutes', 'armGroupLabels': ['Stroke Preparedness Intervention']}, {'name': 'Healthy lifestyle stroke risk reduction intervention', 'type': 'BEHAVIORAL', 'description': 'Face-to-face interaction with research staff lasting between 5-10 minutes', 'armGroupLabels': ['Healthy lifestyle intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48505', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hamilton Community Health Network', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '48505', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hasselbring Senior Center', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}], 'overallOfficials': [{'name': 'Lesli Skolarus, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Neurology', 'investigatorFullName': 'Lesli E. Skolarus, MD', 'investigatorAffiliation': 'University of Michigan'}}}}