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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое SHIFT team intervention
  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 rac

Первичные конечные точки

• Stroke Impact Scale v3.0 [Срок оценки: baseline, 6 months and 1 year]

Вторичные конечные точки (3)

• Blood pressure [Срок оценки: baseline, 6 months and 1 year]
• cognition [Срок оценки: baseline, 6 months and 1 year]
• Stroke Specific Quality of Life (SSQOL) [Срок оценки: 6 months and 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Columbia University Medical Center — New York

Публикации

• 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
• 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

Идентификаторы

NCT: NCT06397937 · ACYY0520 · U01NS135533 · AAAV1743

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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