Recruiting

SHIFT

Sponsor:

Columbia University

Code:

NCT06397937

Conditions

Stroke

Social Determinants of Health

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SHIFT team intervention

Study Details

Brief summary:

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

Study ID

NCT06397937

Start date

Sep 15, 2024

Status verified date

Mar, 2026

Completion date

Jan 31, 2030

Anticipated

Primary completion date

Jan 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

275 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention

The SHIFT intervention team, comprising a community health worker (CHW), community social worker (CSW), and community nurse (CN),will make a first home visit within 72 hours of hospital discharge, and make regular visits to address SDOH barriers identified for each patient, provide individualized counseling, and assist with medication management, risk factor control, and health literacy.

no intervention: Usual Care

All patients will be given standard discharge information, including culturally/racially sensitive stroke education materials for post-stroke care, signs and symptoms of acute stroke, and management of stroke risk factors. Homecare referrals and other rehabilitation services will continue to be provided to discharged patients according to standard-of-care and treating physician referrals. Follow up clinic appointments at 4-6 weeks post discharge will be made with a stroke neurologist per clinical protocol. Thus the only difference between intervention and usual care will be the SHIFT intervention.

Interventions

SHIFT team intervention

The SHIFT team, comprising a community health worker (CHW), community social worker (CHW), and community nurse (CN) will visit the participant starting within 72 hours of hospital discharge and provide social service referrals related to food insecurity, housing, immigration, and employment, and assist with medical appointment preparation (CHW), deliver individualized counseling focused on coping skills, reducing caregiver strain, and the psychological distress associated with experiences of racism and SDOH (CSW), and address health literacy and review of treatment goals and medications (CN).

Primary outcome measure

  • Stroke Impact Scale v3.0 [ Time Frame: baseline, 6 months and 1 year ]

Central Contacts and Locations

Central contacts

Olajide Williams, MD

(212) 305-1710ow11@cumc.columbia.edu

Randolph S Marshall, MD

(212) 305-8389rsm2@cumc.columbia.edu

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Randolph S Marshall, MD

212 305 8389rsm2@columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Apr 8, 2026

Last verified

Mar, 2026

Keywords

  • stroke
  • social determinants of health
  • health disparities
  • community health workers
  • home visits

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-04-08.