Homecare intervention to improve outcomes for stroke patients
Official title: The SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Mitigate Social Determinants of Stroke Outcomes and Build Community Capacity (The SHIFT Trial)
Run by Columbia University · NCT06397937 · Data updated 2026-11-12
This study is testing if a special homecare program with support from health workers can help stroke patients aged 18-75 who face multiple challenges feel better and recover more effectively compared to regular care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 275 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | September 15, 2024 |
| Main results expected | January 31, 2030 |
| Study ends | January 31, 2030 |
| Registry record updated | April 8, 2026 |
| Trial ID | NCT06397937 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are stroke patients aged 18-75 with at least three identified social determinants of health barriers.
✕Probably not a fit
Patients who do not have any social determinants of health barriers or those outside the specified age range may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The SHIFT trial aims to evaluate the effectiveness of a homecare intervention for stroke patients aged 18-75 who have three or more social determinants of health (SDOH) risk factors. This randomized, blinded trial will compare the outcomes of patients receiving the SHIFT intervention, which includes support from community health workers, social workers, and nurses, against those receiving usual care. The primary focus is on improving functional outcomes, physiological measures, and exploring epigenetic biomarkers over a period of six months to one year post-stroke.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance recovery and quality of life for stroke patients facing multiple social challenges.
How similar studies have gone: Previous studies have indicated that addressing social determinants of health can improve health outcomes, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Columbia University Medical Center
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Olajide Williams, MD — Columbia University
- Study coordinator: Olajide Williams, MD
- Email: ow11@cumc.columbia.edu
- Phone: (212) 305-1710
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Remote Ischaemic Conditioning for Fatigue After Stroke 2
Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.