Clinical trial NCT05839327: Impact of Mental Health and Cognitive Disorders on Quality of Life in Severe Covid-19 Survivors
Official title: Impact of Mental Health and Cognitive Disorders on Quality of Life in Severe Covid-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Post-Intensive Care Syndrome
Keywords: COVID-19
Critically ill patients
Cognitive disorders
Post-traumatic stress disorder
Anxiety
Depression
Post-intensive care syndrome
Lead sponsor: Hospital Sao Domingos
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with coronavirus disease 2019 (COVID-19) admitted to intensive care unit requiring invasive and non-invasive respiratory support evaluated at least 3 months after hospital discharge for cognitive and psycological components of post-intensive care syndrome and the impact on quality of life.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Montreal Cognitive Assessment Scale (MOCA)
timeFrame: 6 months after hospital discharge
measure: Hospital Anxiety and depression scale (HADS)
timeFrame: 6 months after hospital discharge
measure: Post-traumatic Stress Disorder Checklist: Civilian Version (PCL-C)
timeFrame: 6 months after hospital discharge
Secondary outcomes:
measure: Mental Component Summary (MCS) of Short Form- 36 (SF-36) Instrument
timeFrame: 6 months after hospital discharge
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Sao Domingos
name: JOAQUIM C LOBATO FILHO, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Sao Domingos
name: JOSE R AZEVEDO, MD, PhD
role: STUDY_CHAIR
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