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

April 30, 2023 updated by: José Raimundo Araujo de Azevedo, Hospital Sao Domingos

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment Scale (MOCA)
Time Frame: 6 months after hospital discharge

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)
Time Frame: 6 months after hospital discharge
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)
Time Frame: 6 months after hospital discharge

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
Time Frame: 6 months after hospital discharge
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sao Domingos

Investigators

  • Principal Investigator: JOAQUIM C LOBATO FILHO, MD, Hospital São Domingos
  • Study Chair: JOSE R AZEVEDO, MD, PhD, Hospital São Domingos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

February 10, 2024

Study Registration Dates

First Submitted

April 30, 2023

First Submitted That Met QC Criteria

April 30, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 30, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19 Post-Intensive Care Syndrome

Clinical Trials on Montreal cognitive assessment scale (MOCA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe