Clinical trial for Stroke
Official title SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes
ClinicalTrials.gov ID: NCT06397937
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding diagnosis of probable cerebral amyloid angiopathy by Boston...
- 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
You likely can't join 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.