An observational study in COVID-19 Post-Intensive Care Syndrome, sponsored by Hospital Sao Domingos. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Hospital Sao Domingos · Observational
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.
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 65 is below the median of 268 across 3,208 observational studies indexed under COVID-19.
Browse COVID-19 studies →Hospital Sao Domingos is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
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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.
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Exclusion Criteria:
Tests to evaluate cognitive disorders (MOCA), anxiety and depression (HADS) Pos-traumatic stress disorder (PCL-C) and quality of life (SF-36)
Also known as: Hospital anxiety and depression scale ( HADS), Post-traumatic stress disorder checklist civilian version (PCL-C), Short form health survey 36 (SF-36)
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
Time frame: 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.
Time frame: 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.
Time frame: 6 months after hospital discharge
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.
Time frame: 6 months after hospital discharge
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jun 2023; primary completion for Sep 2023, 3 months later.
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This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Hospital Sao Domingos