Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Covid19, Critical Care, Postintensive Care Syndrome

Intervention / Treatment
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* Other: Intensive care unit stay during the COVID-19 pandemic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (≥18 years old) Mechanically ventilated for at least 48 hours Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intensive care unit stay during high bed occupancy in the COVID-19 pandemic<br>Adult patients (≥18 years old) who are mechanically ventilated for at least 48 hours in one of the participating ICUs during a high bed occupancy in the pandemic | Other: Intensive care unit stay during the COVID-19 pandemic<br>* Patients will be screened daily for a potential ICU discharge. Each site coordinator, which is a clinician physiotherapist responsible for the site, will check that the patient is delirium-free (CAM-ICU negative) and cooperative (i.e. using 5 standardised questions: open [close] your eyes; look at me; open your mouth and stick out your tongue; nod your head; raise your eyebrows when I have counted up to five) within 72 hours from ICU discharge. Every patient deemed eligible will be invited to participate through a face-to-face visit by the assigned evaluator, receiving verbal and written information about the study<br>|
| Intensive care unit stay during low bed occupancy in the COVID-19 pandemic<br>Adult patients (≥18 years old) who are mechanically ventilated for at least 48 hours in one of the participating ICUs during a low bed occupancy in the pandemic | Other: Intensive care unit stay during the COVID-19 pandemic<br>* Patients will be screened daily for a potential ICU discharge. Each site coordinator, which is a clinician physiotherapist responsible for the site, will check that the patient is delirium-free (CAM-ICU negative) and cooperative (i.e. using 5 standardised questions: open [close] your eyes; look at me; open your mouth and stick out your tongue; nod your head; raise your eyebrows when I have counted up to five) within 72 hours from ICU discharge. Every patient deemed eligible will be invited to participate through a face-to-face visit by the assigned evaluator, receiving verbal and written information about the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | 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) | 6 months after the ICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Frailty Scale | The CFS evaluates specific domains including physical functioning, activities of daily living (ADL), instrumental ADL, assistance for personal care, comorbidities, and cognition to generate a frailty score using a 9-point scale ranging from 1 (very fit) to 9 (terminally ill). A score greater than 4 is considered fragile | Within 72 hours from ICU discharge | 
| Medical Research Council Sum Score (MRC-SS) | standardised examination of six muscle groups bilaterally (i.e. shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension and dorsiflexion) | Within 72 hours from ICU discharge | 
| Functional Status Score for the Intensive Care Unit (FSS-ICU) | The FSS-ICU is a mobility instrument to score the level of physical assistance required when performing five functional activities: rolling, transfer from supine to sit, sitting at the edge of the bed, transfer from sitting to stand, and walking | Within 72 hours from ICU discharge | 
| Montreal Cognitive Assessment-Blind (MoCA blind) | The MoCA blind is a cognitive screening tool designed to detect cognitive dysfunction in five areas: memory, attention, language, abstraction and orientation. It requires 5 minutes to be completed | Within 72 hours from ICU discharge, 3 months, and 6 months after the ICU discharge | 
| Hospital Anxiety and Depression Scale (HADS) | The HADS is an interviewer or self-administered questionnaire designed to identify anxiety and depressive symptoms in a wide variety of in-hospital patients, which requires between 2 and 5 minutes to be completed | Within 72 hours from ICU discharge, 3 months, and 6 months after the ICU discharge | 
| Impact of Events Scale-Revised (IES-R) | The IES-R is an interviewer or self-administered questionnaire designed to measure the subjective distress caused by traumatic events that has been validated for critical illness survivors | Within 72 hours from ICU discharge, 3 months, and 6 months after the ICU discharge | 
| European Quality of Life Health Questionnaire (EQ-5D-3L) | The EQ-5D-3L is an interviewer or self-administered questionnaire of health status or health-related quality of life, including five domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression and global health state | 3 months, and 6 months after the ICU discharge | 
| Employment status | The employment status will be evaluated using tailored questions regarding current occupation, working hours, and any changes to their employment situation as it has been used elsewhere | Within 72 hours from ICU discharge, 3 months, and 6 months after the ICU discharge | 
| Survival | Number of patients who survived | Within 72 hours from ICU discharge, 3 months, and 6 months after the ICU discharge | 
| Actigraphy | To measure sedentary behaviour and physical activity | 6 months after the ICU discharge | 
| Global Physical Activity Questionnaire (GPAQ) | To measure sedentary behaviour and physical activity | 6 months after the ICU discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid19, Critical care, Postintensive Care Syndrome, Rehabilitation, Follow-up