Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-31 @ 2:28 AM
Study NCT ID:
NCT01807793
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2013-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Management Intervention for African-American Men With TIA or Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}], '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'}, {'id': 'D002545', 'term': 'Brain Ischemia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2013-03-06', 'studyFirstSubmitQcDate': '2013-03-07', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication adherence', 'timeFrame': 'Screening/baseline, 3 months, 6 months', 'description': 'The primary outcome will be change in medication treatment adherence with stroke risk reduction pharmacotherapies as measured by the Tablets Routines Questionnaire (TRQ)'}], 'secondaryOutcomes': [{'measure': 'Biological and health behaviors parameters', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Secondary outcomes are changes in biologic parameters of stroke risk (blood pressure, HbA1c, BMI, cholesterol and triglycerides) and in health behaviors (diet, exercise, smoking, substance use) using standardized instruments'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'TIA', 'African American'], 'conditions': ['Stroke', 'Transient Ischemic Attack (TIA)']}, 'descriptionModule': {'briefSummary': 'Stroke is the leading cause of disability, third leading cause of death, and one of the most resource-intensive diseases among Americans. African-Americans (AA) have a stroke rate nearly double that of Euro-Americans (EA), and AA who experience a first-ever stroke are younger, have greater stroke disability, more post-stroke complications, and slower recovery compared to EA.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-identified AA male\n* Between 22 and 64 years of age (\\> age 21 and \\< age 65).\n* Within 6 months of discharge for Stroke /TIA\n* Planned or recent home discharge\n* Barthel Index (BI) score of \\> 60\n* Available care partner willing to participate\n* Be able to speak and understand English\n\nExclusion Criteria:\n\n* Individuals who are unable or unwilling to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT01807793', 'acronym': 'TEAM', 'briefTitle': 'Targeted Management Intervention for African-American Men With TIA or Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': 'Targeted Management Intervention for African-American Men With TIA or Stroke.', 'orgStudyIdInfo': {'id': '1R21NR013001-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21NR013001-01A1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R21NR013001-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21NR013001-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Psychoeducation', 'description': 'Psychoeducation will include attending individual and group sessions.', 'interventionNames': ['Behavioral: Psychoeducation']}, {'type': 'NO_INTERVENTION', 'label': 'Care as usual', 'description': 'Receive care as usual'}], 'interventions': [{'name': 'Psychoeducation', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Psychoeducation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Western Reserve University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Martha Sajatovic, MD', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}