NCT06397937Recruiting
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)
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 275 (estimated)
- First submitted
- 30 Apr 2024
- Start date
- 15 Sept 2024
- Primary completion date
- 31 Jan 2030
- Lead sponsor
- Columbia University
- Diseases
- Stroke
- NCT number
- NCT06397937
What you commit to
- Study type: Interventional
- Planned participants: 275
- From 15 Sept 2024 to the primary completion date, 31 Jan 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of dementia or other neurological diagnosis that affects cognition
- Subarachnoid hemorrhage
Other
- Discharge disposition to a long-term care facility.
- Diagnosis of active major depression
- Aphasia severe enough to preclude initial examination
- Impaired level of consciousness at initial cognitive assessment
- Diagnosis of probable cerebral amyloid angiopathy by Boston criteria
- Life expectancy less than 1 year
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.