The Psychological Impact of Surviving an Intensive Care Admission Due to Coronavirus Disease 2019 (COVID-19) on Patients in the United Kingdom
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,620
- 试验地点
- 50
- 主要终点
- Depression
研究概览
简要总结
Psychological distress is commonly experienced by survivors of an intensive care admission, including patients treated during previous pandemics. Whilst data emerges about the short-term impact of COVID-19 on patients and healthcare systems, the long term impact remains unclear.
The purpose of this trainee-led, multi-centre longitudinal study is to assess the short- and long-term psychological impact on patients who have survived an admission to intensive care due to COVID-19, and identify possible predictors of anxiety, depression and trauma symptoms in this patient group.
详细描述
The primary objective is to identify the proportion of patients surviving an admission to intensive care due to COVID-19 who experience anxiety, depression and/or trauma symptoms in the 6 months post discharge.
Whilst the secondary objectives are to identify demographic, clinical, physical and/or psychosocial predictors of depression, anxiety and/or trauma symptoms at 3-, 6- and 12-months post discharge from ICU. And to assess the feasibility of using a self-reported online questionnaire to assess anxiety, depression and/or trauma symptoms in patients following ICU admission.
An amendment was approved by the East Midlands - Derby Research Ethics Committee on 17 March 2022, to conduct three sub-studies:
- Semi-structured interviews - to explore the experiences of critical care survivors following COVID-19 infection during their recovery phase, including perceptions about the care received and support available to them.
- Survey of follow-up services offered to ICU survivors - to assess geographical differences in the availability and structure of follow-up services offered to patients with critical COVID-19 after hospital discharge.
- Survey of study team members - to gain feedback from the study team members on their involvement in the study.
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
- •Adult patients ≥18 years
- •Survival to intensive care / high dependency unit discharge following an admission of ≥24 hours
- •Treated for COVID-19
排除标准
- •Unable to complete questionnaires
- •Unable or unwilling to consent
- •Unable to speak, understand or communicate in English
- •Patients with diagnosed, pre-existing cognitive impairment (at the time of ICU admission)
- •Patients without a fixed abode, at which postal questionnaires might be received, and who have no access to a personal email address.
结局指标
主要结局
Depression
时间窗: 6 months post ICU discharge
Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case).
Symptoms of trauma
时间窗: 6 months post ICU discharge
Impact of Event Scale-6 (IES-6) where the mean score ranges between 0 and 4 and the cut off score is 1.75.
Anxiety
时间窗: 6 months post intensive care unit (ICU) discharge
Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case).
次要结局
- Depression(3 and/or 12 months post ICU discharge)
- Metacognitive beliefs and processes(3, 6 and/or 12 months post ICU discharge)
- Anxiety(3 and/or 12 months post ICU discharge)
- Symptoms of trauma(3 and/or 12 months post ICU discharge)
- Feasibility of using self-reported questionnaire to assess psychological outcomes in ICU survivors with COVID-19(Study duration, up to 1 year)
- Health-related quality of life(3, 6 and/or 12 months post ICU discharge)
研究者
Alicia Waite
Postdoctoral Clinical Research Fellow
Royal Liverpool University Hospital