SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorColumbia University
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- SHIFT team intervention
Treatment groups
275 Participants
are divided into 2 treatment groupsSponsors and collaborators
Columbia University
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov