Viewing Study NCT05839327



Ignite Creation Date: 2024-05-06 @ 6:56 PM
Last Modification Date: 2024-10-26 @ 2:57 PM
Study NCT ID: NCT05839327
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-05-03
First Post: 2023-04-30

Brief Title: Impact of Mental Health and Cognitive Disorders on Quality of Life in Severe Covid-19 Survivors
Sponsor: Hospital Sao Domingos
Organization: Hospital Sao Domingos

Study Overview

Official Title: Impact of Mental Health and Cognitive Disorders on Quality of Life in Severe Covid-19
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 httpscoronavirusjhuedumaphtml 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None