NCT07331324尚未招募不适用
The Coma Family Program (COMA-F): A Multi-site Clinical Trial of a Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Hospital anxiety and depression scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •1. Serious mental illness, substance misuse, or active suicidal intent or plan - requires higher level of care
研究组 & 干预措施
Coma Family Program 1
Experimental
This arm provides skills training to manage distress, uncertainty, and long-term caregiving challenges.
干预措施: Coma Family Program 1 (Behavioral)
Coma Family Program 2
Placebo Comparator
This arm involves providing education about managing caregiving distress, uncertainty, and long-term challenges.
干预措施: Coma Family Program 2 (Behavioral)
结局指标
主要结局
Hospital anxiety and depression scale
时间窗: baseline, 6-weeks, and 3-month follow-up
Measures anxiety and depression. Anxiety and depression sub scales each range from 0 (minimum) to 21 (maximum) with higher scores meaning worse outcome.
次要结局
- Posttraumatic stress disorder checklist-5(baseline, 6-weeks, and 3-month follow-up)
- World Health Organization Quality of Life-Short Form(baseline, 6-weeks, and 3-month follow-up)
研究者
Alexander Presciutti
Member of the Faculty
Massachusetts General Hospital
研究点 (3)
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