NCT06397937 SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes
| NCT ID | NCT06397937 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 275 participants |
| Start Date | 2024-09-15 |
| Primary Completion | 2030-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 275 participants in total. It began in 2024-09-15 with a primary completion date of 2030-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Olajide Williams, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT06397937 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06397937 currently recruiting?
Yes, NCT06397937 is actively recruiting participants. Contact the research team at ow11@cumc.columbia.edu for enrollment information.
Where is the NCT06397937 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06397937 clinical trial?
NCT06397937 is sponsored by Columbia University. The principal investigator is Olajide Williams, MD at Columbia University. The trial plans to enroll 275 participants.
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