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)
Columbia University
275 participants
Sep 15, 2024
INTERVENTIONAL
Conditions
Summary
Primary Goal: To 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).
Eligibility
Inclusion Criteria10
- Ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding diagnosis of probable cerebral amyloid angiopathy by Boston Criteria)
- African American/Black or Hispanic race-ethnicity
- Age 18-75 years old
- Have at least 3 SDOH barriers from within the 5 SDOH domains (Social and Community, Education, Economic, neighborhood/environment, Health Care)
- Have a discharge plan to 1) home with or without home services, or 2) acute rehabilitation with plan to return home after
- Pre-stroke Modified Rankin Scale score of ≤3
- Residence in New York City.
- English or Spanish speaking.
- Can provide informed consent and engage in the initial assessment prior to stroke discharge
- 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.
Exclusion Criteria8
- Discharge disposition to a long-term care facility.
- Diagnosis of dementia or other neurological diagnosis that affects cognition
- Diagnosis of active major depression
- Aphasia severe enough to preclude initial examination
- Impaired level of consciousness at initial cognitive assessment
- Subarachnoid hemorrhage
- Diagnosis of probable cerebral amyloid angiopathy by Boston criteria
- Life expectancy less than 1 year
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Interventions
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).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06397937