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

NCT ID: NCT05839327

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-02-10

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.

Conditions

COVID-19 Post-Intensive Care Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Hospital anxiety and depression scale ( HADS); Post-traumatic stress disorder checklist civilian version (PCL-C); Short form health survey 36 (SF-36)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Sao Domingos

OTHER

Sponsor Role: lead

Responsible Party

José Raimundo Araujo de Azevedo

ICU Assistent Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JOAQUIM C LOBATO FILHO, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Sao Domingos

JOSE R AZEVEDO, MD, PhD

Role: STUDY_CHAIR

Hospital Sao Domingos

Central Contacts

JOSE R AZEVEDO, MD, PhD

Role: CONTACT

jrazevedo47@gmail.com

+559832168110

JOAQUIM C LOBATO FILHO, MD

Role: CONTACT

joaquimhclobato@gamil.com

+559832168110

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Other Identifiers

15/2023

Identifier Type: -

Identifier Source: org_study_id