No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
275 (estimated)
Sponsor
Columbia University · Other
Who this trial is looking for
This trial is looking for stroke patients aged 18-75 who have at least three social and health-related challenges. Participants will receive homecare support to help improve their recovery over 6 months to a year.
Are You a Good Fit for This Trial?
You may be able to join if
I have had an ischemic stroke or primary intracerebral hemorrhage.
I am African American/Black or Hispanic.
I am between 18 and 75 years old.
I have at least 3 social or health-related challenges.
I will go home after leaving the hospital or go to rehab before going home.
My pre-stroke disability score was 3 or less.
I live in New York City.
I can speak English or Spanish.
You may not be able to join if
I will be discharged to a long-term care facility.
I have been diagnosed with dementia or a serious cognitive issue.
I have active major depression.
I have severe difficulty speaking that prevents my assessment.
I have impaired consciousness when assessed.
I have had a subarachnoid hemorrhage.
I have been diagnosed with probable cerebral amyloid angiopathy.
I have a life expectancy of less than 1 year.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 tel…
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).
Trial Locations
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City
State
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Status
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 …
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
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