The SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Mitigate Social Determinants of Stroke Outcomes and Build Community Capacity (The SHIFT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Stroke Impact Scale v3.0
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: SHIFT team intervention (Behavioral)
Usual Care
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.
结局指标
主要结局
Stroke Impact Scale v3.0
时间窗: baseline, 6 months and 1 year
a validated measure of disability and health-related quality of life after stroke
次要结局
- Blood pressure(baseline, 6 months and 1 year)
- Stroke Specific Quality of Life (SSQOL)(6 months and 1 year)
- cognition(baseline, 6 months and 1 year)
研究者
Olajide Williams
Professor of Neurology
Columbia University