[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546668":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":56,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":18,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Columbia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","The SHIFT intervention team, comprising a community health worker (CHW), community social worker (CSW), and community nurse (CN),will make a first home visit within 72 hours of hospital discharge, and make regular visits to address SDOH barriers identified for each patient, provide individualized counseling, and assist with medication management, risk factor control, and health literacy.",[13],"Behavioral: SHIFT team intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","NO_INTERVENTION","All patients will be given standard discharge information, including culturally\u002Fracially sensitive stroke education materials for post-stroke care, signs and symptoms of acute stroke, and management of stroke risk factors. Homecare referrals and other rehabilitation services will continue to be provided to discharged patients according to standard-of-care and treating physician referrals. Follow up clinic appointments at 4-6 weeks post discharge will be made with a stroke neurologist per clinical protocol. Thus the only difference between intervention and usual care will be the SHIFT intervention.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","SHIFT team intervention","The SHIFT team, comprising a community health worker (CHW), community social worker (CHW), and community nurse (CN) will visit the participant starting within 72 hours of hospital discharge and provide social service referrals related to food insecurity, housing, immigration, and employment, and assist with medical appointment preparation (CHW), deliver individualized counseling focused on coping skills, reducing caregiver strain, and the psychological distress associated with experiences of racism and SDOH (CSW), and address health literacy and review of treatment goals and medications (CN).",[9],[26],{"name":27,"affiliation":5,"role":28},"Olajide Williams, MD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","(212) 305-1710","ow11@cumc.columbia.edu",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Randolph S Marshall, MD","(212) 305-8389","rsm2@cumc.columbia.edu",[39],{"facility":40,"status":41,"city":42,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Columbia University Medical Center","RECRUITING","New York","10032","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-74.00597,40.71427,{"lat":50,"lon":49},[53],{"name":35,"role":31,"phone":54,"phoneExt":18,"email":55},"212 305 8389","rsm2@columbia.edu",{"type":28,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Olajide Williams","Professor of Neurology",[60],{"name":61,"class":62},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH","100546668","sdoh-homecare-intervention-focus-team-shift-trial-to-improve-stroke-outcomes-100546668",false,"NCT06397937","SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes","The SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Mitigate Social Determinants of Stroke Outcomes and Build Community Capacity (The SHIFT Trial)","SHIFT","Inclusion Criteria:\n\n* Ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding diagnosis of probable cerebral amyloid angiopathy by Boston Criteria)\n* African American\u002FBlack or Hispanic race-ethnicity\n* Age 18-75 years old\n* Have at least 3 SDOH barriers from within the 5 SDOH domains (Social and Community, Education, Economic, neighborhood\u002Fenvironment, Health Care)\n* Have a discharge plan to 1) home with or without home services, or 2) acute rehabilitation with plan to return home after\n* Pre-stroke Modified Rankin Scale score of ≤3\n* Residence in New York City.\n* English or Spanish speaking.\n* Can provide informed consent and engage in the initial assessment prior to stroke discharge\n* Lives in a household with a telephone, and has a caregiver (family member or Home Health Aide) if not fully independent on discharge. If the patient requires a family member to assist with activities of daily living or decision-making, the family member must state a willingness to be present at home visits where their assistance is needed.\n\nExclusion Criteria:\n\n* Discharge disposition to a long-term care facility.\n* Diagnosis of dementia or other neurological diagnosis that affects cognition\n* Diagnosis of active major depression\n* Aphasia severe enough to preclude initial examination\n* Impaired level of consciousness at initial cognitive assessment\n* Subarachnoid hemorrhage\n* Diagnosis of probable cerebral amyloid angiopathy by Boston criteria\n* Life expectancy less than 1 year","ALL","18 Years","75 Years",{"count":75,"type":76},275,"ESTIMATED","INTERVENTIONAL",[79],"NA","Primary Goal:\n\nTo test the hypothesis that among stroke patients 18-75 years with ≥3 SDOH risk factors, SHIFT will improve: (1) functional outcomes as measured by the SIS (Primary Outcome), (2) physiological outcomes as measured by changes in blood pressure and cognition, (secondary outcomes) and (3) epigenetic allostatic load biomarkers (exploratory outcome) such as DNA methylation (DNAm) and telomere length, at 6 months and 1-year post-stroke, compared with usual care (UC).",[82,83],"Stroke","Social Determinants of Health",[85,86,87,88,89],"stroke","social determinants of health","health disparities","community health workers","home visits","2026-04-03",{"date":92,"type":93},"2026-04-08","ACTUAL",{"date":95,"type":93},"2024-09-15",{"date":97,"type":76},"2030-01-31",{"name":5,"class":6},1]