Actively Recruiting
SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes
Led by Columbia University · Updated on 2026-04-08
275
Participants Needed
1
Research Sites
280 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosis of ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding probable cerebral amyloid angiopathy)
- African American/Black or Hispanic ethnicity
- At least 3 social determinants of health barriers from social/community, education, economic, neighborhood/environment, or health care domains
- Discharge plan to home (with or without home services) or acute rehabilitation with plan to return home
- Pre-stroke Modified Rankin Scale score of 3 or less
- Residence in New York City
- English or Spanish speaker
- Able to provide informed consent and participate in initial assessment before discharge
- Lives in a household with a telephone
- Has a caregiver (family member or Home Health Aide) if not fully independent at discharge, with caregiver willing to assist during home visits if needed
You will not qualify if you...
- Discharge to a long-term care facility
- Diagnosis of dementia or other neurological condition affecting cognition
- Diagnosis of active major depression
- Severe aphasia preventing initial examination
- Impaired consciousness at initial cognitive assessment
- Subarachnoid hemorrhage
- Probable cerebral amyloid angiopathy by Boston criteria
- Life expectancy less than 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
O
Olajide Williams, MD
CONTACT
R
Randolph S Marshall, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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