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

NCT06397937 | Recruiting

• 3 other identifiers: ACYY0520U01NS135533AAAV1743
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Stroke Impact Scale v3.0

  a validated measure of disability and health-related quality of life after stroke

  baseline, 6 months and 1 year

Secondary Outcomes (3)

• Blood pressure

  baseline, 6 months and 1 year

• cognition

  baseline, 6 months and 1 year

• Stroke Specific Quality of Life (SSQOL)

  6 months and 1 year

Other Outcomes (3)

• Medication Adherence

  6 months and 1 year

• 30-day readmission rate

  30 days post discharge

• Epigenetic biomarkers of stress

  baseline, 6 months and 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: SHIFT team intervention

Usual Care

NO INTERVENTION

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 BEHAVIORAL

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).

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Related Publications (2)

• Harris J, Boehme A, Chan L, Moats H, Dugue R, Izeogu C, Pavol MA, Naqvi IA, Williams O, Marshall RS. Allostatic load predicts racial disparities in intracerebral hemorrhage cognitive outcomes. Sci Rep. 2022 Oct 3;12(1):16556. doi: 10.1038/s41598-022-20987-x.

  PMID: 36192526 BACKGROUND

• Mallaiah J, Williams O, Allegrante JP. Development and Validation of a Stroke Literacy Assessment Test for Community Health Workers. Health Educ Behav. 2024 Oct;51(5):764-774. doi: 10.1177/10901981241245050. Epub 2024 Apr 22.

  PMID: 38646736 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Olajide Williams, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olajide Williams, MD

CONTACT

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

Randolph S Marshall, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Model Details: Phase 3, randomized, blinded outcome

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): January 31, 2030
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: As per NIH/NINDS requirements
• Access Criteria: All items required by NIH/NINDS will be publicly shared.

Locations

US (1)