Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-03 @ 7:21 PM
Study NCT ID:
NCT01900756
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2013-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tailored Hospital-based Risk Reduction to Impede Vascular Events After 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2013-07-12', 'studyFirstSubmitQcDate': '2013-07-12', 'lastUpdatePostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reduction of disability and enhanced quality of life.', 'timeFrame': '1 year'}], 'primaryOutcomes': [{'measure': 'Reduction in systolic blood pressure', 'timeFrame': '1 year', 'description': 'Reduction in systolic blood pressure at one year post-discharge in stroke patients.'}], 'secondaryOutcomes': [{'measure': 'Reduced rate of subsequent primary vascular event', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '31805787', 'type': 'DERIVED', 'citation': 'Owolabi MO, Gebregziabher M, Akinyemi RO, Akinyemi JO, Akpa O, Olaniyan O, Salako BL, Arulogun O, Tagge R, Uvere E, Fakunle A, Ovbiagele B. Randomized Trial of an Intervention to Improve Blood Pressure Control in Stroke Survivors. Circ Cardiovasc Qual Outcomes. 2019 Dec;12(12):e005904. doi: 10.1161/CIRCOUTCOMES.119.005904. Epub 2019 Dec 6.'}, {'pmid': '25042605', 'type': 'DERIVED', 'citation': 'Owolabi MO, Akinyemi RO, Gebregziabher M, Olaniyan O, Salako BL, Arulogun O, Ovbiagele B. Randomized controlled trial of a multipronged intervention to improve blood pressure control among stroke survivors in Nigeria. Int J Stroke. 2014 Dec;9(8):1109-16. doi: 10.1111/ijs.12331. Epub 2014 Jul 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a culturally-sensitive multipronged post-discharge intervention can significantly reduce blood pressure, enhance achievement of guideline recommended targets for risk factor control, and lower recurrent vascular events in a low-income and middle-income (LMIC). The study will have 2 Phases - a qualitative phase (Phase 1) lasting less than one year involving development of the intervention through focus group methodologies and structured interviews, and a clinical trial phase (Phase 2)lasting 3 years involving a randomized trial testing the efficacy of the intervention.', 'detailedDescription': 'This research seeks to develop an effective and sustainable way of reducing the devastating and deadly impact of stroke in a low-income region of the world with poor medical infrastructure. It will do so by focusing on improving the treatment of the condition most closely tied to stroke, hypertension, using novel methods that incorporate the input of the local community. If successful, the strategy could serve as a ready model to be adapted by decision-makers in other under-resourced areas for lessening the burden of stroke(and other major public health challenges).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Phase 1: Inclusion Criteria:\n\nAge ≥ 18 years Stroke within one year access to mobile phone.\n\nExclusion Criteria:\n\nAny medical condition that would limit participation in follow up assessments, Severe cognitive impairment/dementia (MMSE ≤24) Severe global disability (modified Rankin Score ≥ 3).'}, 'identificationModule': {'nctId': 'NCT01900756', 'acronym': 'THRIVES', 'briefTitle': 'Tailored Hospital-based Risk Reduction to Impede Vascular Events After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Tailored Hospital-based Risk Reduction to Impede Vascular Events After Stroke', 'orgStudyIdInfo': {'id': '1U01NS079179', 'link': 'https://reporter.nih.gov/quickSearch/1U01NS079179', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Behavioral', 'description': '1. Pre-appointment phone text\n2. In-clinic educational video\n3. Patient report card\n4. Post-clinic phone text\n5. Outpatient stroke registry', 'interventionNames': ['Behavioral: THRIVES']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'Routine and customary management.'}], 'interventions': [{'name': 'THRIVES', 'type': 'BEHAVIORAL', 'description': 'Pre-appointment phone text In-clinic educational video Patient report card Post-clinic phone text Outpatient stroke registry', 'armGroupLabels': ['Behavioral']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abeokuta', 'state': 'Ogun State', 'country': 'Nigeria', 'facility': 'Sacred Heart Hospital', 'geoPoint': {'lat': 7.15571, 'lon': 3.34509}}, {'city': 'Abeokuta', 'country': 'Nigeria', 'facility': 'Federal Medical Centre', 'geoPoint': {'lat': 7.15571, 'lon': 3.34509}}, {'city': 'Ibadan', 'country': 'Nigeria', 'facility': 'University College Hospital', 'geoPoint': {'lat': 7.37756, 'lon': 3.90591}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}