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

NCT05839327 | Unknown

• 1 other identifier: 15/2023
• Study Type: observational
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  6 months after hospital discharge

Secondary Outcomes (1)

• Mental Component Summary (MCS) of Short Form- 36 (SF-36) Instrument

  6 months after hospital discharge

Interventions

Montreal cognitive assessment scale (MOCA) DIAGNOSTIC_TEST

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Still hospitalized or inpatient in rehabilitation facility
• Previous cognitive impairmant

Sponsors & Collaborators

• Hospital Sao Domingos: lead

Related Publications (13)

• Lambermont B, Rousseau AF, Seidel L, Thys M, Cavalleri J, Delanaye P, Chase JG, Gillet P, Misset B. Outcome Improvement Between the First Two Waves of the Coronavirus Disease 2019 Pandemic in a Single Tertiary-Care Hospital in Belgium. Crit Care Explor. 2021 May 19;3(5):e0438. doi: 10.1097/CCE.0000000000000438. eCollection 2021 May.

  PMID: 34079951 BACKGROUND

• Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.

  PMID: 21946660 RESULT

• Nalbandian A, Sehgal K, Gupta A, Madhavan MV, McGroder C, Stevens JS, Cook JR, Nordvig AS, Shalev D, Sehrawat TS, Ahluwalia N, Bikdeli B, Dietz D, Der-Nigoghossian C, Liyanage-Don N, Rosner GF, Bernstein EJ, Mohan S, Beckley AA, Seres DS, Choueiri TK, Uriel N, Ausiello JC, Accili D, Freedberg DE, Baldwin M, Schwartz A, Brodie D, Garcia CK, Elkind MSV, Connors JM, Bilezikian JP, Landry DW, Wan EY. Post-acute COVID-19 syndrome. Nat Med. 2021 Apr;27(4):601-615. doi: 10.1038/s41591-021-01283-z. Epub 2021 Mar 22.

  PMID: 33753937 RESULT

• Martillo MA, Dangayach NS, Tabacof L, Spielman LA, Dams-O'Connor K, Chan CC, Kohli-Seth R, Cortes M, Escalon MX. Postintensive Care Syndrome in Survivors of Critical Illness Related to Coronavirus Disease 2019: Cohort Study From a New York City Critical Care Recovery Clinic. Crit Care Med. 2021 Sep 1;49(9):1427-1438. doi: 10.1097/CCM.0000000000005014.

  PMID: 33769771 RESULT

• Mongodi S, Salve G, Tavazzi G, Politi P, Mojoli F; COVID-19 Post-ICU team; COVID-19 Pavia Crisis Unit. High prevalence of acute stress disorder and persisting symptoms in ICU survivors after COVID-19. Intensive Care Med. 2021 May;47(5):616-618. doi: 10.1007/s00134-021-06349-7. Epub 2021 Mar 17. No abstract available.

  PMID: 33730197 RESULT

• Ramani C, Davis EM, Kim JS, Provencio JJ, Enfield KB, Kadl A. Post-ICU COVID-19 Outcomes: A Case Series. Chest. 2021 Jan;159(1):215-218. doi: 10.1016/j.chest.2020.08.2056. Epub 2020 Aug 21. No abstract available.

  PMID: 32835708 RESULT

• Valent A, Dudoignon E, Ressaire Q, Depret F, Plaud B. Three-month quality of life in survivors of ARDS due to COVID-19: A preliminary report from a French academic centre. Anaesth Crit Care Pain Med. 2020 Dec;39(6):740-741. doi: 10.1016/j.accpm.2020.10.001. Epub 2020 Oct 10. No abstract available.

  PMID: 33049394 RESULT

• Writing Committee for the COMEBAC Study Group; Morin L, Savale L, Pham T, Colle R, Figueiredo S, Harrois A, Gasnier M, Lecoq AL, Meyrignac O, Noel N, Baudry E, Bellin MF, Beurnier A, Choucha W, Corruble E, Dortet L, Hardy-Leger I, Radiguer F, Sportouch S, Verny C, Wyplosz B, Zaidan M, Becquemont L, Montani D, Monnet X. Four-Month Clinical Status of a Cohort of Patients After Hospitalization for COVID-19. JAMA. 2021 Apr 20;325(15):1525-1534. doi: 10.1001/jama.2021.3331.

  PMID: 33729425 RESULT

• McCue C, Cowan R, Quasim T, Puxty K, McPeake J. Long term outcomes of critically ill COVID-19 pneumonia patients: early learning. Intensive Care Med. 2021 Feb;47(2):240-241. doi: 10.1007/s00134-020-06313-x. Epub 2020 Nov 9. No abstract available.

  PMID: 33169214 RESULT

• Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.

  PMID: 33428867 RESULT

• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 RESULT

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 RESULT

• Jenkinson C, Layte R, Jenkinson D, Lawrence K, Petersen S, Paice C, Stradling J. A shorter form health survey: can the SF-12 replicate results from the SF-36 in longitudinal studies? J Public Health Med. 1997 Jun;19(2):179-86. doi: 10.1093/oxfordjournals.pubmed.a024606.

  PMID: 9243433 RESULT

MeSH Terms

Conditions

COVID-19 post-intensive care syndrome; COVID-19; Cognitive Dysfunction; Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression; postintensive care syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavioral Symptoms; Behavior

Study Officials

• JOAQUIM C LOBATO FILHO, MD

  Hospital Sao Domingos

  PRINCIPAL INVESTIGATOR

• JOSE R AZEVEDO, MD, PhD

  Hospital Sao Domingos

  STUDY CHAIR

Central Study Contacts

JOSE R AZEVEDO, MD, PhD

CONTACT

+559832168110; jrazevedo47@gmail.com

JOAQUIM C LOBATO FILHO, MD

CONTACT

+559832168110; joaquimhclobato@gamil.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ICU Assistent Physician

Study Record Dates

• First Submitted: April 30, 2023
• First Posted: May 3, 2023
• Study Start: June 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: February 10, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share