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

• ClinicalTrials.gov Identifier: NCT04979897
• Recruitment Status: Recruiting
• First Posted: July 28, 2021
• Last Update Posted: July 28, 2021
• Sponsor: Universidad del Desarrollo
• Collaborators: Clinica Alemana de Santiago; Clínica INDISA; Clínica BUPA; Hospital del Salvador; Hospital Regional Dr. Leonardo Guzmán de Antofagasta; Hospital San Pablo de Coquimbo; Hospital Metropolitano
• Information provided by (Responsible Party): Ana Cristina Castro, Universidad del Desarrollo

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Covid19; Critical Care; Postintensive Care Syndrome	Other: Intensive care unit stay during the COVID-19 pandemic

Study Design

• Study Type: Observational
• Estimated Enrollment: 450 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: October 5, 2020
• Estimated Primary Completion Date: November 2, 2021
• Estimated Study Completion Date: February 2, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
Intensive care unit stay during high bed occupancy in the COVID-19 pandemic; 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; 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
Intensive care unit stay during low bed occupancy in the COVID-19 pandemic; 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; 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

Outcome Measures

Primary Outcome Measures :

1. World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: 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)

Secondary Outcome Measures :

1. Clinical Frailty Scale [ Time Frame: Within 72 hours from ICU discharge ]
   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
2. Medical Research Council Sum Score (MRC-SS) [ Time Frame: Within 72 hours from ICU discharge ]
   standardised examination of six muscle groups bilaterally (i.e. shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension and dorsiflexion)
3. Functional Status Score for the Intensive Care Unit (FSS-ICU) [ Time Frame: Within 72 hours from ICU discharge ]
   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
4. Montreal Cognitive Assessment-Blind (MoCA blind) [ Time Frame: Within 72 hours from ICU discharge, 3 months, and 6 months after the ICU discharge ]
   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
5. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Within 72 hours from ICU discharge, 3 months, and 6 months after the ICU discharge ]
   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
6. Impact of Events Scale-Revised (IES-R) [ Time Frame: Within 72 hours from ICU discharge, 3 months, and 6 months after the ICU discharge ]
   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
7. European Quality of Life Health Questionnaire (EQ-5D-3L) [ Time Frame: 3 months, and 6 months after the ICU discharge ]
   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
8. Employment status [ Time Frame: Within 72 hours from ICU discharge, 3 months, and 6 months after the ICU discharge ]
   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
9. Survival [ Time Frame: Within 72 hours from ICU discharge, 3 months, and 6 months after the ICU discharge ]
   Number of patients who survived
10. Actigraphy [ Time Frame: 6 months after the ICU discharge ]
    To measure sedentary behaviour and physical activity
11. Global Physical Activity Questionnaire (GPAQ) [ Time Frame: 6 months after the ICU discharge ]
    To measure sedentary behaviour and physical activity

Other Outcome Measures:

1. Consent rate [ Time Frame: Every month during one year ]
   Number of patients who agreed to participate divided by the number of patients who meet selection criteria
2. Cohort retention rate [ Time Frame: Every month during one year ]
   Number of patients who can be contacted and evaluated

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Adults who were mechanically ventilated in the ICU, either with the diagnosis of COVID-19 or other causes

Criteria

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)

Contacts and Locations

Contacts

Contact: Felipe González-Seguel, MSc; 989540683; feligonzalezs@udd.cl

Contact: Ana Castro-Ávila, PhD; anacastro@udd.cl

Locations

Chile

Hospital Regional Dr. Leonardo Guzmán de Antofagasta; Recruiting

Antofagasta, Chile

Contact: Yerko Villagra

Principal Investigator: Yerko Villagra

Sub-Investigator: Pilar Castro

Hospital San Pablo de Coquimbo; Recruiting

Coquimbo, Chile

Contact: Eduardo González

Principal Investigator: Eduardo González

Clínica Alemana de Santiago; Recruiting

Santiago, Chile

Contact: Agustín Camus-Molina, MSc

Principal Investigator: Agustín Camus-Molina, MSc

Sub-Investigator: Felipe González-Seguel, MSc

Clínica BUPA; Recruiting

Santiago, Chile

Contact: Javiera Aguilera

Principal Investigator: Javiera Aguilera

Sub-Investigator: Joaquín Olave

Clínica INDISA; Recruiting

Santiago, Chile

Contact: Felipe Muñoz-Muñoz, MSc

Principal Investigator: Felipe Muñoz-Muñoz, MSc

Hospital del Salvador; Recruiting

Santiago, Chile

Contact: Camilo Cáceres

Principal Investigator: Camilo Cáceres

Sub-Investigator: Macarena Leiva-Corvalán

Hospital Metropolitano; Recruiting

Santiago, Chile

Contact: Fernanda Baus

Principal Investigator: Fernanda Baus

Sponsors and Collaborators

Universidad del Desarrollo

Clinica Alemana de Santiago

Clínica INDISA

Clínica BUPA

Hospital del Salvador

Hospital Regional Dr. Leonardo Guzmán de Antofagasta

Hospital San Pablo de Coquimbo

Hospital Metropolitano

Investigators

• Principal Investigator: Ana Castro-Ávila, PhD; Universidad del Desarrollo

More Information

Additional Information:

Custom-made study web site 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Castro-Avila AC, Merino-Osorio C, Gonzalez-Seguel F, Camus-Molina A, Leppe J; IMPACCT COVID-19 study group. Impact on Mental, Physical and Cognitive functioning of a Critical care sTay during the COVID-19 pandemic (IMPACCT COVID-19): protocol for a prospective, multicentre, mixed-methods cohort study. BMJ Open. 2021 Sep 8;11(9):e053610. doi: 10.1136/bmjopen-2021-053610.

• Responsible Party: Ana Cristina Castro, Visiting lecturer, Universidad del Desarrollo
• ClinicalTrials.gov Identifier: NCT04979897
• Other Study ID Numbers: 2020-78
• First Posted: July 28, 2021
• Last Update Posted: July 28, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ana Cristina Castro, Universidad del Desarrollo:

Covid19; Critical care; Postintensive Care Syndrome; Rehabilitation; Follow-up

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases