SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes

Description

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).

Conditions

Stroke, Social Determinants of Health

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Study Overview

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Study Details

Study overview

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).

The SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Mitigate Structural Racism in Stroke Outcomes and Build Community Capacity (The SHIFT Trial)

SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes

Condition
Stroke
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding diagnosis of probable CAA)
  • 2. African American/Black or Hispanic race-ethnicity.
  • 3. Age 18-75 years old.
  • 4. Have at least 3 SDOH barriers from within the 5 SDOH domains (Social and Community, Education, Economic, neighborhood/environment, Health Care).
  • 5. Have a discharge plan to 1) home with or without home services, or 2) acute rehabilitation with plan to return home after.
  • 6. Pre-stroke Modified Rankin Scale score of ≤3
  • 7. Residence in New York City..
  • 8. English or Spanish speaking.
  • 9. Can provide informed consent and engage in the initial assessment prior to stroke discharge.
  • 10. 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.
  • 1. Discharge disposition to a long term care facility.
  • 2. Diagnosis of dementia or other neurological neurological diagnosis that affects cognition.
  • 3. Diagnosis of active major depression.
  • 4. Aphasia severe enough to preclude initial examination.
  • 5. Impaired level of consciousness at initial cognitive assessment.
  • 6. Subarachnoid hemorrhage.
  • 7. Diagnosis of probable cerebral amyloid angiopathy by Boston criteria.
  • 8. Life expectancy less than 1 year.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Columbia University,

Richard T Benson, MD, STUDY_DIRECTOR, NINDS Office of Global Health and Health Disparities

Study Record Dates

2029-01-31