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Идёт набор NCT06188364

Improving Traumatic Brain Injury Rehab Care With Comm Health Services: a Research Project Within the TBI Model System

Ранняя фаза I С лечением Traumatic Brain Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Standard of Care, Experimental.
Кому может быть актуально
Состояния в реестре: Traumatic Brain Injury. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Improving Traumatic Brain Injury Rehabilitation Care Transitions With Community Health Services: A Randomized Clinical Trial (CHW Intervention for TBI Care Transitions [CHWI for TBI]), a Research Project Within the TBI Model System

Обзор

TBI rehabilitation care transitions refer to the processes of preparing patients, families, and community-based healthcare providers for the patient's passage from inpatient rehabilitation to the home and community or to another level of care. Persons with TBI have heterogenous neurological impairment (cognitive and behavioral foremost, along with motor, sensory, and balance), that limits their functional independence and participation, and increases their risk for secondary medical conditions, injuries, rehospitalizations and early mortality

Подробное описание

Once people with TBI and their care partners enter the post-acute care landscape, they must navigate fragmented health care systems, interact with providers who may be unfamiliar with TBI, and discover their own services and supports. Inpatient rehabilitation provides high levels of structure and professional support that are impossible to replicate when constructing a home environment to independently manage day-to-day care. Once home, the person with TBI's physical, cognitive, behavioral, and medical needs can easily overwhelm even the most committed care partners. Community health workers (CHWs) through a combination of care coordination, advocacy, and direct service delivery, have the potential to address TBI care partners' needs, particularly those from low income and/or traditionally underserved minority groups. CHWs are well-suited to fill resource gaps that TBI care partners have difficulty finding, including: (1) finding diagnostic, treatment, and social services; (2) assisting with referrals; (3) providing health education and motivational interviewing to support behavioral health change; (4) collecting and managing clinical data; (5) facilitating productive relationships between health services and communities, and (6) offering psychosocial support.

Вмешательства

  • Другое Standard of Care
    The usual Transition Supports and Services (USS) that prepare care partners of persons with TBI for post-rehabilitation discharge, so the the delivery of traditional CHW outreach services such as finding health, community and social determinants referrals, problem-solving, and connecting care partners to long-term supports/services
  • Другое Experimental
    Novel aspects of the CHW experimental intervention for TBI care partners include: 1. CHW services begin prior to inpatient rehabilitation discharge; 2. care partners get timely, useful health management materials; 3. encounters focus on unlimited, brief, situation-focused calls to help care partners assess and resolve pressing concerns; and 4. long-term support capacity for care partners is built by establishing a reliable referral network of medical, community, and social services that become

Первичные конечные точки

  • Managing Your loved Ones Health - Care Partner Activation [Срок оценки: Measured at 12-weeks post-discharge]
Вторичные конечные точки (2)
  • Caregiver Well-Being Scale - Short Form (CWBS-SF) - Care Partner Well-Bing [Срок оценки: Measured at 24-weeks post-discharge]
  • Patient Health Questionnaire - 4 (PHQ-4) - Care Partner Emotional Distress [Срок оценки: Measured at 12- and 24-weeks post-discharge.]

Критерии участия

Критерии включения

  • Participants must be adults (age 18 or older).
  • Must be primary person responsible for supervision/care needs of person with TBI post-IRF discharge.
  • The person with TBI must have been admitted to the Brain Injury Service Unit at SAI.
  • If the care partner does not live in the same residence as the person with TBI, they must provide multiple daily check-ins on day-to-day care.
  • Must agree to use mHealth (texts, calls) and possess or be eligible to acquire a smart phone.

Критерии исключения

  • Any severe cognitive impairment that precludes the ability to provide informed consent or safely function as the care partner for a vulnerable adult with TBI.

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
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Virginia Commonwealth University — Richmond

Идентификаторы

NCT: NCT06188364 · HM20027800

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗