SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes
Recruiting now · Not applicable
Conditions studied: Stroke, Social Determinants of Health
In brief
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).
Key facts
- Study ID
- NCT06397937
- Run by
- Columbia University
- People needed
- 275
- Starts
- 2024-09-15
- Expected to finish
- 2030-01-31
- Last updated by the study team
- 2026-04-08
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Columbia University Medical Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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