Impact of a COVID-19 Related ICU Stay on Mental Health for Patients and Their Relatives. An Exploratory 18-month Follow-up Study for COVID-19 ICU Survivors and Their Relatives.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Composite outcome: Prevalence of psychiatric symptoms among relatives of COVID-19 ICU survivors
研究概览
简要总结
As ICU mortality has been significantly decreased over the last two decades, the focus has been shifting from short term (such as ICU and hospital mortality) to long-term outcome. This evolution has led to a new entity that has been established in 2012 at a stakeholder conference: the Post-Intensive Care Syndrome (PICS). It is defined as impairments in physical, cognitive and mental health status arising after critical illness and persisting beyond acute care hospitalisation. As family members of ICU patients may also be affected by mental health impairment, the PICS-F (F for Family) has been introduced simultaneously.
It is expected that the COVID-19 pandemic will result in a significant increase of the proportion of patients and relatives suffering PICS and PICS-F, as there is during the COVID-19 related ICU-stay exposure to a high number of risk factors for developing these entities.
This Post Intensive Care Syndrome in COVID-19 survivors (PICOVIDS) study is an observational, single-center exploratory follow-up cohort study that aims to get insight into the mental impact of a COVID-19 related ICU stay for COVID-19 ICU survivors and their family members, 18 months after ICU discharge.
Specific research questions are:
- What is the prevalence of symptoms of depression, anxiety and Post Traumatic Stress Disorder (PTSD) and what is the prevalence of these specific disorders in COVID-19 ICU-survivors and their relatives 18 months after ICU-discharge?
- What are important risk factors for these symptoms and disorders?
- What is the satisfaction level of patient and caregiver about the ICU care: How did they experience ICU stay?
详细描述
Design:
The Post Intensive Care Syndrome in COVID-19 survivors (PICOVIDS) study is an observational, single-center exploratory follow-up cohort study in a non-university hospital with 31 ICU beds.
Objective:
The study aims to get insight into the mental impact of a COVID-19 related ICU stay for COVID-19 ICU survivors and their family members, 18 months after ICU discharge.
Specific research questions are:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •COVID-19 patient admitted to the ICU between 1st of March 2020 and 31st of May 2021
- •Surviving ICU and index hospitalisation
- •Respiratory failure due to COVID-19 with need for High Flow Oxygen Therapy (HFOT), non-invasive ventilation (NIV) or mechanical ventilation (MV)
- •Family member (caregiver) of eligible COVID-19
- •Written informed consent obtained from patient and family member
排除标准
- •ICU length of stay (ICU-LOS) </= 72h
- •Decease of the COVID-19 patient during 18-month follow-up period
- •Respiratory failure and admission to ICU was not primary related to COVID-19
- •Poor or moderate knowledge of Dutch, French or English language
- •Mentally not able to complete questionnaires or to give informed consent, due to a neurocognitive deficit
结局指标
主要结局
Composite outcome: Prevalence of psychiatric symptoms among relatives of COVID-19 ICU survivors
时间窗: 18 months after ICU discharge
symptoms of anxiety(1), depression(2) and PTSD(3) (1+2) anxiety and depression measured using the HADS symptom score (score range 0 (best) to 42 (worst)): presence of symptoms of anxiety if HADS anxiety subscale \> 7; presence of symptoms of depression if HADS depression subscale \> 8; (3) presence of PTSD-related symptoms measured using the PCL-5 COVID score (score range 17 (not all PTSD) to 85(most extreme form of PTSD): PTSD symptoms if score \> 32.
Composite outcome: Prevalence of psychiatric symptoms in COVID-19 ICU survivors
时间窗: 18 months after ICU discharge
symptoms of anxiety(1), depression(2) and PTSD(3) (1+2) anxiety and depression measured using the HADS symptom score (score range 0 (best) to 42 (worst)): presence of symptoms of anxiety if HADS anxiety subscale \> 7; presence of symptoms of depression if HADS depression subscale \> 8; (3) presence of PTSD-related symptoms measured using the PCL-5 COVID score (score range 17 (not all PTSD) to 85(most extreme form of PTSD): PTSD symptoms if score \> 32.
次要结局
- Composite outcome: Prevalence of psychiatric disorders among relatives of COVID ICU survivors.(18 months after ICU discharge)
- Patient and relatives' satisfaction level about continuity of care after hospital discharge(18 months after ICU discharge)
- Composite outcome: Prevalence of psychiatric disorders among COVID ICU survivors.(18 months after ICU discharge)
- Prevalence of cognitive impairment in COVID-19 ICU survivors and their relatives(18 months after ICU discharge)
- Impact of caring for COVID-19 ICU survivor after hospital discharge on the relative(18 months after ICU discharge)
研究者
Stoffel Lamote
Medical Doctor, Intensive Care Unit
General Hospital Groeninge