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NCT Number: NCT06397937

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

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).

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Randolph S Marshall, MD

CONTACT

[email protected]

212 305 8389

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Stroke Impact Scale v3.0

    Time frame: baseline, 6 months and 1 year

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

Secondary outcomes

  1. Blood pressure

    Time frame: baseline, 6 months and 1 year

    change in blood pressure from baseline

  2. cognition

    Time frame: baseline, 6 months and 1 year

    Montreal Cognitive Assessment battery (MoCA)

  3. Stroke Specific Quality of Life (SSQOL)

    Time frame: 6 months and 1 year

    validated quality of life measure

Other outcomes

  1. Medication Adherence

    Time frame: 6 months and 1 year

    medication adherence

  2. 30-day readmission rate

    Time frame: 30 days post discharge

    incidence of readmission to the hospital within 30 days of discharge

  3. Epigenetic biomarkers of stress

    Time frame: baseline, 6 months and 1 year

    DNA methylation, telomere length

Study contacts

Contact information is provided by the study sponsor or research team.

Olajide Williams, MD

CONTACT

[email protected]

(212) 305-1710

Randolph S Marshall, MD

CONTACT

[email protected]

(212) 305-8389

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Acronym: SHIFT

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
May 3, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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