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SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes | Clinical Trials | Clareo Health

RECRUITINGNA

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

The SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Mitigate Social Determinants of Stroke Outcomes and Build Community Capacity (The SHIFT Trial)

NCT06397937•Columbia University

View on ClinicalTrials.gov

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).

Detailed Description

Adverse Social Determinants of Health (SDOH) have been shown increase stroke risk in a dose dependent manner. The SDOH-Homecare Intervention Focus Team (SHIFT) trial is a Phase 3, randomized, blinded outcome trial that tests the hypothesis that a homecare intervention shortly after discharge from an acute stroke unit by a team comprising a community health worker (CHW), a community social worker (CSW) and a community nurse (CN) can improve health outcomes among stroke patients with three or more SDOH compared with UC.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Columbia University Medical Center

New York, New York, United States

Key Dates

Start Date

September 15, 2024

Primary Completion Date

January 31, 2029

Completion Date

January 31, 2029

Last Updated

March 12, 2026

Enrollment

275

ESTIMATED participants

Conditions

StrokeSocial Determinants of Health

Interventions

SHIFT team intervention

BEHAVIORAL

Contacts

Olajide Williams, MD

CONTACT

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

Randolph S Marshall, MD

CONTACT

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

Cerebellar Stimulation for Aphasia Rehabilitation

NCT05093673

Stroke

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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants

NCT07371455

Ischemic Stroke

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Effects of Circuit Training Combining Different Types of Distal Robot-assisted and Task-oriented Therapy on Motor Control, Motor and Daily Functions, and Quality of Life After Stroke

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Cerebellar Stimulation for Aphasia Rehabilitation

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants

Effects of Circuit Training Combining Different Types of Distal Robot-assisted and Task-oriented Therapy on Motor Control, Motor and Daily Functions, and Quality of Life After Stroke

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Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

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