Набор скоро начнётся NCT07331324

The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury

Без фазы С лечением Caregiver Distress Emotional Distress Caregivers Resilience

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: Coma Family Program 1, Coma Family Program 2.
Кому может быть актуально: Состояния в реестре: Caregiver Distress, Emotional Distress, Caregivers, Resilience. 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 →

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Официальное название

The Coma Family Program (COMA-F): A Multi-site Clinical Trial of a Resilience Program for Caregivers of Patients With Severe Acute Brain Injury

Обзор

The purpose of this research study is to determine whether COMA-F is more efficacious at reducing emotional distress in caregivers of patients with severe acute brain injuries, compared to health education control.

Вмешательства

Поведенческое Coma Family Program 1
This intervention provides skills training to manage distress, uncertainty, and long-term caregiving challenges.
Поведенческое Coma Family Program 2
This involves education (but no skills training) about managing caregiving distress, uncertainty, and long-term challenges.

Первичные конечные точки

Hospital anxiety and depression scale [Срок оценки: baseline, 6-weeks, and 3-month follow-up]

Вторичные конечные точки (2)

Posttraumatic stress disorder checklist-5 [Срок оценки: baseline, 6-weeks, and 3-month follow-up]
World Health Organization Quality of Life-Short Form [Срок оценки: baseline, 6-weeks, and 3-month follow-up]

Критерии участия

Критерии включения

18 years or older - study population
English fluency and literacy - measures and intervention are in English
Screens positive for emotional distress on either depression or anxiety subscales (>7) of the Hospital Anxiety and Depression scale - study population (caregivers must be at-risk for chronic distress via heightened acute distress)
Confirmed by the clinical team as the primary caregiver of a patient who has been admitted to an intensive care unit (ICU) with a severe acute brain injury with the following characteristics:

18 years or older - study population
Admitted with ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, traumatic brain injury, or hypoxic-ischemic encephalopathy - study population
Glasgow Coma Scale score below 9 (in judgement of the clinical team) while not intubated or an inability to follow meaningful commands while intubated at any point during the hospitalization for > 24 consecutive hours due to the brain injury itself and not a confounding factor (e.g., sedation or seizures) - study population
Still alive in ICU at the time the clinical team approaches the caregiver about possible recruitment - excludes caregivers of those that passed away as would require a different intervention (e.g., grieving intervention)
Has been committed to or has already received long-term life-sustaining treatments including tracheostomy and/or percutaneous endoscopic or surgical gastrostomy tube placement (trach or PEG) - study population; at time of enrollment patients can be in various early stages of cognitive/functional recovery from initial coma, but all were severe enough to require trach and/or PEG
Has a prognosis for survival of greater than 3 months and does not have a concurrent diagnosis of a terminal illness or injury as judged by the clinical team - as in "d"; such caregivers would require different intervention
Is still in ICU or has been transferred to a lower level of care (e.g., stepdown) for <7 days at the time of consent - study population; we aim to begin the intervention when caregivers are acutely distressed in the context of the patient's ICU stay or shortly after the ICU stay (i.e., within 7 days of leaving)