Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic (IMPACCT COVID-19): a Prospective, Multicentre, Mixed-methods Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 7
- 主要终点
- World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
研究概览
简要总结
Intensive care unit (ICU) survivors and their families frequently present mental, cognitive and physical impairments lasting years. The ongoing pandemic could affect the duration, variety, and severity of these impairments. Our aim is to determine the impact of the COVID-19 pandemic on the physical, mental, and cognitive health of survivors, the experience of their families and their treating healthcare professionals in the long-term.
This is a prospective, multicentre, mixed-methods cohort study in seven Chilean ICUs. The perceptions of family members regarding the ICU stay and the later recovery will be explored 3 months after discharge. Health care professionals will be invited to discuss the challenges faced during the pandemic using semi-structured interviews.
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 old)
- •Mechanically ventilated for at least 48 hours
排除标准
- •Unable to walk independently 2 weeks prior to ICU admission (with or without a gait aid)
- •S5q < 5 or CAM-ICU positive within 72 hours after ICU discharge
- •Patient who do not understand or speak Spanish
- •Patient unable to communicate verbally
- •Burn or severe trauma as admission diagnosis
- •Any neurological disorder (i.e. spinal cord injury, stroke and brain tumours) as admission diagnosis
- •Transferred to a non-participating study centre before ICU discharge assessment
- •Recent prolonged hospital stay (extended by more than 3 months)
结局指标
主要结局
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
时间窗: 6 months after the ICU discharge
The WHODAS 2.0 is a self-reported disability questionnaire based on the International Classification of Functioning, Disability, and Health (ICF). It includes 36 questions, organised under six domains (cognition, mobility, self-care, getting along, life activities and participation). Each question must be answered based on the perceived difficulty for performing activities using a 5-point scale (none, mild, moderate, severe and extreme). The overall score of each domain, it is transformed into a score between 0 and 100, where 0 means no disability and 100 is complete disability
次要结局
- Medical Research Council Sum Score (MRC-SS): Peripheral Muscle Strength(Within 72 hours from ICU discharge)
- Clinical Frailty Scale(Within 72 hours from ICU discharge)
- Survival(6 months after the ICU discharge)
- Hospital Anxiety and Depression Scale (HADS)(6 months after the ICU discharge)
- Employment Status(6 months after the ICU discharge)
- Montreal Cognitive Assessment-Blind (MoCA Blind)(6 months after the ICU discharge)
- Impact of Events Scale-Revised (IES-R)(6 months after the ICU discharge)
- Functional Status Score for the Intensive Care Unit (FSS-ICU)(Within 72 hours from ICU discharge)
- European Quality of Life Health Questionnaire (EQ-5D-3L)(6 months after the ICU discharge)
研究者
Ana Cristina Castro
Visiting lecturer
Universidad del Desarrollo