Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06397937

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

Led by Columbia University · Updated on 2026-04-08

275

Participants Needed

1

Research Sites

280 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 75 years
  • Diagnosis of ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding probable cerebral amyloid angiopathy)
  • African American/Black or Hispanic ethnicity
  • At least 3 social determinants of health barriers from social/community, education, economic, neighborhood/environment, or health care domains
  • Discharge plan to home (with or without home services) or acute rehabilitation with plan to return home
  • Pre-stroke Modified Rankin Scale score of 3 or less
  • Residence in New York City
  • English or Spanish speaker
  • Able to provide informed consent and participate in initial assessment before discharge
  • Lives in a household with a telephone
  • Has a caregiver (family member or Home Health Aide) if not fully independent at discharge, with caregiver willing to assist during home visits if needed
Not Eligible

You will not qualify if you...

  • Discharge to a long-term care facility
  • Diagnosis of dementia or other neurological condition affecting cognition
  • Diagnosis of active major depression
  • Severe aphasia preventing initial examination
  • Impaired consciousness at initial cognitive assessment
  • Subarachnoid hemorrhage
  • Probable cerebral amyloid angiopathy by Boston criteria
  • Life expectancy less than 1 year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

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Research Team

O

Olajide Williams, MD

CONTACT

R

Randolph S Marshall, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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