Psychological Impact of Medical Evacuations on Families of Patients Admitted to Intensive Care Unit for Severe COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Comparison of the prevalence of post-traumatic stress disorder, among families of patients with severe COVID-19 evacuated to another region (case) compared to families of matched patients with severe COVID-19 not evacuated to another region (controls).
研究概览
简要总结
At the "Métropole Savoie" hospital, to deal with the daily influx of severe patients during the second wave of COVID-19, 23 patients had to be transferred away from their home city and far from their families as part of a medical evacuation (EVASAN).
The purpose of the study is to investigate whether there is an association between medical evacuations and the occurrence of psychological disorders such as post-traumatic stress, anxiety or depression occurring within 6 to 10 months in families of evacuated patients.
The investigators want to compare the prevalence of psychological disorders in the families of patients evacuated for a serious form of COVID-19 (cases) compared to that of families of patients not evacuated (controls) hospitalized for a serious form of COVID-19.
详细描述
The case group is trusted person of evacuated patient. The control group is trusted person of not evacuated patient.
The trusted person of the group control will be matched to trusted patient of the case group on :
their relationship with the patient (spouse/ascendant/descendant/other) and on criteria specific to the patient: sex, age range ( <75 years or ≥ 75 years), invasive ventilation and becoming at 3 months post COVID-19 (survivor / non survivor)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Trusted person of patients admitted to the Adult Intensive Care Unit (ICU) of the "Metropole Savoie"hospital
- •during the second wave of COVID-19 in France
- •for a serious form of COVID-19
- •hospitalized more than 72 hours in ICU
- •the case group is trusted person of evacuated patient. the control group is trusted person of not evacuated patient.
- •Non -inclusion criteria :
- •Trusted Person Refusing patient Medical Evacuation
排除标准
- 未提供
结局指标
主要结局
Comparison of the prevalence of post-traumatic stress disorder, among families of patients with severe COVID-19 evacuated to another region (case) compared to families of matched patients with severe COVID-19 not evacuated to another region (controls).
时间窗: at 8months (+/-2 months) after medical evacuations for the case group, and at 8 months (+/-2 months) after ICU admission for the control group
the post-traumatic stress disorder of the trusted person is assessed by the Impact of Event Scale - Revised (IES-R), at 8months (+/-2 months) after medical evacuations for the case group, and at 8 months (+/-2 months) after Intensive Care Unit (ICU) admission for the control group
次要结局
- Qualitative analysis by a psychologist of a semi-structured interview of the testimony and specific experience of families at 8 months.(at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.)
- Prevalence of anxiety and/or depression symptoms questionnaire in families of patients hospitalized with severe COVID-19.(at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.)
- Quality of Life in families of patients with severe COVID-19(at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.)
- Satisfaction with the communication between the health care team and the family of the patient hospitalized with severe form of COVID19(at 8 months (+/- 2months) in families of patients hospitalized in intensive care for a serious form of COVID-19.)