"Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers" "Impact Psychologique de l'épidémie COVID-19 Chez Les Patients, Familles et Soignants de Reanimation" "BURDENCOV"
试验速览
- 阶段
- 不适用
- 入组人数
- 1,464
- 试验地点
- 3
- 主要终点
- PTSD Family members sup 22
研究概览
简要总结
Coronavirus disease 2019 (COVID-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection is highly contagious requiring restrictive and stressful measures for patients, family members and ICU healthcare providers. To avoid contagion, patient isolation has become the rule. For patients, these measures add stress to the ICU environment and deprive them of unrestricted family visits. Family members are not only left with fear but also many unanswered questions. In end-of-life situations, many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process. The impact of exclusion or limited inclusion certainly needs to be explored. Moreover, ICU caregivers are having to face new challenges and to work in a unknown situation, juggling with both professional issues such as increased workload, working longer hours and safety issues, and personal issues such as child care and transport as well as family transmission of the virus.
The main objective of this study is to demonstrate that the COVID-19 pandemic, as compared to seasonal flu and community acquired pneumonia, significantly increases post-traumatic stress disorder (PTSD) in family members of critically ill patients.
PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge. The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. It will be compared across the three groups (COVID-19, FLU and CAP).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients:
- •Admission to the participating ICUs for any cause of acute respiratory failure during the COVID-19 pandemic
- •Having received invasive or noninvasive mechanical ventilation
- •Non-opposition to participate to the telephone interviews.
- •Family members:
- •Non-opposition to participate to the telephone interviews
- •One family member per patient: the family member the most implicated in the patient's care
- •Healthcare providers:
- •All nurses and physicians (including those in training) in the participating ICUs during the COVID-19 pandemic
排除标准
- •Patients:
- •Language barrier to be able to respond to the telephone interview
- •Cognitive disorders disabling patients to respond to the telephone interview
- •Person under legal protection (1121-8 of CSP, Public Health Code) Failure to obtain the non-opposition
- •Family members:
- •Language barrier to be able to respond to the telephone interview
- •Person under legal protection (1121-8 of CSP, Public Health Code)
- •Failure to obtain the non-opposition
- •Healthcare providers:
- •Failure to obtain the non-opposition
结局指标
主要结局
PTSD Family members sup 22
时间窗: 90 days
Proportion of Family members with IES-R\> 22 PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge of corresponding patient. It si a scale ranging from 0 to 88. Weiss, DS.; Marmar, CR. The impact of event scale - revised. In: Wilson, JP.; Keane, TM., editors.Assessing psychological trauma and PTSD. New York: Guilford Press; 1997. p. 399-411
次要结局
- SF36 Patients(90 days)
- PTSD Family members(90 days)
- HADS Family members(90 days)
- Questionnaire Family members(90 days)
- Questionnaire Patients(90 days)
- PTSD healthcare providers(2 months after official end of the Covid-19 peak)
- Questionnaire healthcare providers(2 months after official end of the Covid-19 peak)
- MBI healthcare providers(2 months after official end of the Covid-19 peak)
- Karasec instrument healthcare providers(2 months after official end of the Covid-19 peak)
- HADS Patients(90 days)
- PTSD Patients(90 days)