SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes
- Conditions
- StrokeSocial Determinants of Health
- Interventions
- Behavioral: SHIFT team intervention
- Registration Number
- NCT06397937
- Lead Sponsor
- Columbia University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- Ischemic stroke (arterial subtypes) or primary intracerebral hemorrhage (excluding diagnosis of probable CAA)
- 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.
- Discharge disposition to a long term care facility.
- Diagnosis of dementia or other neurological 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention SHIFT team 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.
- Primary Outcome Measures
Name Time Method Stroke Impact Scale v3.0 baseline, 6 months and 1 year a validated measure of disability and health-related quality of life after stroke
- Secondary Outcome Measures
Name Time Method Blood pressure baseline, 6 months and 1 year change in blood pressure from baseline
Stroke Specific Quality of Life (SSQOL) 6 months and 1 year validated quality of life measure
cognition baseline, 6 months and 1 year Montreal Cognitive Assessment battery (MoCA)
Trial Locations
- Locations (1)
Columbia University Medical Center
🇺🇸New York, New York, United States