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

Covid19 Clinical Trial

— IMPACCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04979897
• Other study ID #: 2020-78
• Status: Recruiting
• Start date: October 5, 2020
• Est. completion date: February 2, 2022

Study information

• Verified date: July 2021
• Source: Universidad del Desarrollo
• Contact: Felipe González-Seguel, MSc
• Phone: 989540683
• Email: feligonzalezs[@]udd.cl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: February 2, 2022
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Covid19
• Critical Care
• Postintensive Care Syndrome
• Syndrome

Intervention

Other:
• Intensive care unit stay during the COVID-19 pandemic
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

Locations

Country	Name	City	State
Chile	Hospital Regional Dr. Leonardo Guzmán de Antofagasta	Antofagasta
Chile	Hospital San Pablo de Coquimbo	Coquimbo
Chile	Clínica Alemana de Santiago	Santiago
Chile	Clínica BUPA	Santiago
Chile	Clínica INDISA	Santiago
Chile	Hospital del Salvador	Santiago
Chile	Hospital Metropolitano	Santiago

Sponsors (8)

Lead Sponsor	Collaborator
Universidad del Desarrollo	Clinica Alemana de Santiago, Clínica BUPA, Clínica INDISA, Hospital del Salvador, Hospital Metropolitano, Hospital Regional Dr. Leonardo Guzmán de Antofagasta, Hospital San Pablo de Coquimbo

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Consent rate	Number of patients who agreed to participate divided by the number of patients who meet selection criteria	Every month during one year
Other	Cohort retention rate	Number of patients who can be contacted and evaluated	Every month during one year
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Survival	Number of patients who survived	Within 72 hours from ICU discharge, 3 months, and 6 months after the ICU discharge
Secondary	Actigraphy	To measure sedentary behaviour and physical activity	6 months after the ICU discharge
Secondary	Global Physical Activity Questionnaire (GPAQ)	To measure sedentary behaviour and physical activity	6 months after the ICU discharge

External Links

•   Custom-made study web site