NCT04979897: IMPACCT

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

Completed Results posted Last updated 12 July 2024

What this trial tests

trial testing Intensive care unit stay during the COVID-19 pandemic in Covid19 in 252 participants. Completed in 2 September 2022.

Timeline

20 October 2020

Primary endpoint
2 November 2021

2 September 2022

Quick facts

Lead sponsor	Universidad del Desarrollo
Status	Completed
Study type	OBSERVATIONAL
Enrollment	252
Start date	20 October 2020
Primary completion	2 November 2021
Estimated completion	2 September 2022
Sites	7 locations across Chile

Drugs / interventions tested

• Intensive care unit stay during the COVID-19 pandemic

Conditions studied

• Covid19 — all drugs for Covid19 →
• Critical Care — all drugs for Critical Care →
• Postintensive Care Syndrome — all drugs for Postintensive Care Syndrome →

Sponsor

Universidad del Desarrollo — full company profile →

Who can join

18 and older, any sex, with Covid19 or Critical Care. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Primary · 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

Group	Value	95% CI
Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic	5	2 – 18
Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic	13.5	2 – 23

Clinical Frailty Scale Secondary · 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

Group	Value	95% CI
Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic	2	2 – 3
Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic	3	2 – 3

Medical Research Council Sum Score (MRC-SS): Peripheral Muscle Strength Secondary · Within 72 hours from ICU discharge

the MRC-SS consists of a standardised examination of six muscle groups bilaterally (i.e. shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension and dorsiflexion). All muscle groups are scored using a 6-point scale between 0 and 5 (0 = no visible /palpable contraction; 1 = visible / palpable contraction or no limb movement; 2 = limb movement, but not against gravity; 3 = movement against the gravity over nearly the entire range of motion; 4 = motion against gravity and resistance, subjectively adjusted for gender and age; 5 = normal force). The score goes from 0 (no str

Group	Value	95% CI
Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic	52	46 – 57
Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic	50	44 – 57

Functional Status Score for the Intensive Care Unit (FSS-ICU) Secondary · 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. Each activity is scored using a 7-point scale ranging from 0 (not able to perform) to 7 (complete independence). The resulting overall score ranges from 0 to 35 points, where a higher scores indicates better performance.

Group	Value	95% CI
Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic	26	21 – 32
Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic	27	19 – 32

Montreal Cognitive Assessment-Blind (MoCA Blind) Secondary · 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. Each domain is scored separately for a total score ranging from 0 to 22 points. A score equal to or greater than 18 points is considered normal cognition.

Group	Value	95% CI
Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic	21	19 – 22
Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic	20	18 – 22

Hospital Anxiety and Depression Scale (HADS) Secondary · 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. The HADS has fourteen questions, seven for anxiety and seven for depressive symptoms. Each question is rated with a 4-point scale ranging from 0 ("absence") to 3 ("extreme presence"), resulting in a sum score of 21 points per subscale. For each subscale, a score \>8 indicates suspected anxiety or depression, while a score \>11 indicates clinical symptoms of anxiety or depression.

Depression subscale

Group	Value	95% CI
Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic	7	5 – 8
Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic	7	5 – 9

Anxiety subscale

Group	Value	95% CI
Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic	6	3 – 9
Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic	7	3 – 10

Impact of Events Scale-Revised (IES-R) Secondary · 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. It comprises 22 questions in three subscales: intrusion, avoidance, and hyperarousal. Questions are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The score goes from 0 to 88 points. Scores above 33 are indicative of post-traumatic stress symptoms.

Group	Value	95% CI
Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic	13.5	5 – 38
Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic	22	7 – 44

European Quality of Life Health Questionnaire (EQ-5D-3L) Secondary · 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. Each domain is scored based on 3 levels of severity: no problems, some problems, and extreme problems. Each combination of answers can be translated into a utility score, where 0 is similar to being dead and 1 represents the best possible quality of life. The utility scores were obtained using the Chilean Social valuation of EQ-5D health states (DOI: http:

Group	Value	95% CI
Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic	0.79	0.57 – 1.00
Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic	0.74	0.51 – 0.79

Employment Status Secondary · 6 months after the ICU discharge

The employment status was evaluated using the following questions: What is your current employment status? What working hours do you have? and has your employment situation changed after your ICU stay?

Group	Value	95% CI
Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic	18
Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic	17
Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic	3
Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic	3
Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic	4
Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic	9
Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic	4
Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic	8

Survival Secondary · 6 months after the ICU discharge

Number of patients who survived

Group	Value	95% CI
Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic	148
Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic	95

Cohort Retention Rate Secondary · Every month during one year

Number of patients who can be contacted and evaluated

Group	Value	95% CI
Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic	30
Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic	37

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Castro-Ávila AC, Merino-Osorio C, González-Seguel F, Camus-Molina A, et al · · 2021 · cited 5× · PMID 34497087 · DOI 10.1136/bmjopen-2021-053610
2. Six-month post-intensive care outcomes during high and low bed occupancy due to the COVID-19 pandemic: A multicenter prospective cohort study.
   Castro-Avila A, Merino-Osorio C, González-Seguel F, Camus-Molina A, et al · · 2023 · cited 4× · PMID 37972091 · DOI 10.1371/journal.pone.0294631
3. Abstracts
   · 2022 · cited 1×
4. Six-Month Post-Intensive Care Outcomes During High and Low Bed Occupancy due to the COVID-19 Pandemic: a Multicenter Prospective Cohort Study
   Castro-Ávila A, Merino-Osorio C, González-Seguel F, Camus-Molina A, et al · · 2023 · DOI 10.21203/rs.3.rs-3137590/v1