Clinical trial NCT04979897: Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Critical Care
Postintensive Care Syndrome
Keywords: Covid19
Critical care
Postintensive Care Syndrome
Rehabilitation
Follow-up
Lead sponsor: Universidad del Desarrollo
Sponsor class: OTHER
Collaborators: name: Clinica Alemana de Santiago
name: Clinica Indisa
name: Clinica Bupa Santiago
name: Hospital del Salvador
name: Hospital Clínico Regional De Antofagasta Dr Leonardo Guzman
name: Hospital San Pablo de Coquimbo
name: Hospital Metropolitano
First posted: 2021-07-28
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults who were mechanically ventilated in the ICU, either with the diagnosis of COVID-19 or other causes

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.


Eligibility 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)

Primary outcomes:
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: 6 months after the ICU discharge
Secondary outcomes:
measure: Clinical Frailty Scale
timeFrame: Within 72 hours from ICU discharge
measure: Medical Research Council Sum Score (MRC-SS): Peripheral Muscle Strength
timeFrame: Within 72 hours from ICU discharge
measure: Functional Status Score for the Intensive Care Unit (FSS-ICU)
timeFrame: Within 72 hours from ICU discharge
measure: Montreal Cognitive Assessment-Blind (MoCA Blind)
timeFrame: 6 months after the ICU discharge
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months after the ICU discharge
measure: Impact of Events Scale-Revised (IES-R)
timeFrame: 6 months after the ICU discharge
measure: European Quality of Life Health Questionnaire (EQ-5D-3L)
timeFrame: 6 months after the ICU discharge
measure: Employment Status
timeFrame: 6 months after the ICU discharge
measure: Survival
timeFrame: 6 months after the ICU discharge
Other outcomes:
measure: Cohort Retention Rate
timeFrame: Every month during one year
Locations:
city: Antofagasta
country: Chile
facility: Hospital Regional Dr. Leonardo Guzmán de Antofagasta
city: Coquimbo
country: Chile
facility: Hospital San Pablo de Coquimbo
city: Santiago
country: Chile
facility: Clínica Alemana de Santiago
city: Santiago
country: Chile
facility: Clínica BUPA
city: Santiago
country: Chile
facility: Clínica INDISA
city: Santiago
country: Chile
facility: Hospital del Salvador
city: Santiago
country: Chile
facility: Hospital Metropolitano
Study officials:
affiliation: Universidad del Desarrollo
name: Ana Castro-Ávila, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.