Clinical trial NCT06397937: SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes
Official title: The SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Mitigate Social Determinants of Stroke Outcomes and Build Community Capacity (The SHIFT Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Social Determinants of Health
Keywords: stroke
social determinants of health
health disparities
community health workers
home visits
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2024-05-03
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 3, randomized, blinded outcome
Primary purpose: PREVENTION

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).

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 criteria: Inclusion Criteria:

1. Ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding diagnosis of probable CAA)
2. Age 18-75 years old.
3. Have at least 3 SDOH barriers from within the 5 SDOH domains (Social and Community, Education, Economic, neighborhood/environment, Health Care).
4. Have a discharge plan to 1) home with or without home services, or 2) acute rehabilitation with plan to return home after.
5. Pre-stroke Modified Rankin Scale score of ≤3
6. Residence in New York City..
7. English or Spanish speaking.
8. Can provide informed consent and engage in the initial assessment prior to stroke discharge.
9. 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:

1. Discharge disposition to a long term care facility.
2. Diagnosis of dementia or other neurological neurological diagnosis that affects cognition.
3. Diagnosis of active major depression.
4. Aphasia severe enough to preclude initial examination.
5. Impaired level of consciousness at initial cognitive assessment.
6. Subarachnoid hemorrhage.
7. Diagnosis of probable cerebral amyloid angiopathy by Boston criteria.
8. Life expectancy less than 1 year.

Primary outcomes:
measure: Stroke Impact Scale v3.0
timeFrame: baseline, 6 months and 1 year
Secondary outcomes:
measure: Blood pressure
timeFrame: baseline, 6 months and 1 year
measure: cognition
timeFrame: baseline, 6 months and 1 year
measure: Stroke Specific Quality of Life (SSQOL)
timeFrame: 6 months and 1 year
Other outcomes:
measure: Medication Adherence
timeFrame: 6 months and 1 year
measure: 30-day readmission rate
timeFrame: 30 days post discharge
measure: Epigenetic biomarkers of stress
timeFrame: baseline, 6 months and 1 year
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: NINDS Office of Global Health and Health Disparities
name: Richard T Benson, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.