Impact of Mental Health and Cognitive Disorders on Quality of Life in Severe Covid-19 Survivors

Study Overview
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Brief Summary
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The objective of this single-center retrospective observational study is to describe cognitive and psychological outcomes and their impact on quality of life after at least 3 months of intensive care unit (ICU) discharge in severe COVID-19 survivors.

Detailed Description
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Background: The COVID-19 pandemic has already affected more than 600 million people worldwide and resulted in at least 6 million deaths (https:coronavirus.jhu.edu/map.html). The pandemic has also resulted in a growing population of individuals recovering from acute SARS-CoV-2 infection. Accumulating observational data suggest that these patients often experience a wide range of symptoms after recovery from acute illness. The dysfunctions ranging from motor, cognitive disability, anxiety, depression and post-traumatic stress disorder. However, there is still unknown data about the occurrence of mental health manifestations after a critical illness and their consequences in mid term quality of life. Purpose: Many patients with coronavirus disease 2019 (COVID-19) required critical care. Mid-term outcomes of the survivors need to be assessed. The objective of this single-center retrospective observational study is to describe their cognitive and psychological outcomes and their impact on quality of life afer at least 3 months following intensive care unit (ICU)-discharge. Objectives: Our objective will be to evaluate the incidence of non-physical post-intensive care syndrome, such as symptoms of anxiety, depression, cognitive and post-traumatic stress disorder (PTSD) after hospital discharge in our severe COVID-19 population, as well as determining their long-term consequences in quality of life (QoL). Methods: An observational retrospective study will be conducted, including all patients with severe COVID-19 admitted to the intensive care unit of a private tertiary hospital from April 2020 to October 2021. Patients were routinely assessed after 3 months of ICU discharge in our multidisciplinary follow-up clinic. A trained research team routinely applied the Montreal Cognitive Assessment Scale (MOCA), Hospital Anxiety and Depression Scale (HADS), PCL-C (Post-traumatic Stress Disorder Checklist: Civilian Version) and Short Form Health Survey 36 (SF-36), during the follow-up evaluation.

Official Title
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Impact of Mental Health and Cognitive Disorders on Quality of Life in Severe Covid-19

Conditions
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COVID-19 Post-Intensive Care Syndrome

Intervention / Treatment
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* Diagnostic Test: Montreal cognitive assessment scale (MOCA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All 18 years and older patients with severe COVID-19, confirmed by real-time reverse transcriptase-polymerase chain reaction., admitted to a 15- bed intensive care unit of a tertiary hospital from April 2020 to October 2021. Exclusion Criteria: Still hospitalized or inpatient in rehabilitation facility Previous cognitive impairmant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Montreal cognitive assessment scale (MOCA)|Tests to evaluate cognitive disorders (MOCA), anxiety and depression (HADS) Pos-traumatic stress disorder (PCL-C) and quality of life (SF-36)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment Scale (MOCA) | The MoCA total score was used for analysis: it ranges from 0 to 30, the lower scores indicating worse cognitive performances. The validated cut-off of 26 was used to distinguish light cognitive disorders (≥ 26) and proven cognitive impairments (< 26) The MoCA total score was used for analysis: it ranges from 0 to 30, the lower scores indicating worse cognitive performances. The validated cut-off of 26 was used to distinguish light cognitive disorders (≥ 26) and proven cognitive impairments (< 26) The MoCA total score was used for analysis: it ranges from 0 to 30, the lower scores indicating worse cognitive performances. The validated cut-off of 26 was used to distinguish light cognitive disorders (≥ 26) and proven cognitive impairments (< 26) The MOCA total score was used for analysis: it ranges from 0 to 30, the lower scores indicating worse cognitive performances. The validated cut-off of 26 was used to distinguish light cognitive disorder (> 26) and | 6 months after hospital discharge | 
| Hospital Anxiety and depression scale (HADS) | The HADS consists of two 7-item subscales evaluating symptoms of depression (seven items-HADS-D subscale) and symptoms of anxiety (seven items-HADS-A subscale). The standard cutoff threshold value of > 7 out of 21 on either subscale was used to define a borderline status (score 8 to 10) or clinically significant status (score 11 to 21) of depression or anxiety, respectively. | 6 months after hospital discharge | 
| Post-traumatic Stress Disorder Checklist: Civilian Version (PCL-C) | PCL-C is an instrument designed to assess the consequences of a number of different types of traumatic experience. To complete the questionnaire, the subject should gauge to what extent they have been disturbed by the symptoms described during the previous month, using a scale of severity from 1 to 5 (not at all to very much). It defines a score greater than or equal to 3 (average) for any of the 17 items as clinically significant. PCL-C is an instrument designed to assess the consequences of a number of different types of traumatic experience. To complete the questionnaire, the subject should gauge to what extent they have been disturbed by the symptoms described during the previous month, using a scale of severity from 1 to 5 (not at all to very much). It defines a score greater than or equal to 3 (average) for any of the 17 items as clinically significant. | 6 months after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Component Summary (MCS) of Short Form- 36 (SF-36) Instrument | MCS is composed of scales assessing mental function, role limitations caused by mental problems, bodily pain and general health. The result scale ranges from 0 to 100, with 0 being the worst result and 100 the best. | 6 months after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Critically ill patients, Cognitive disorders, Post-traumatic stress disorder, Anxiety, Depression, Post-intensive care syndrome