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Clinical Trials/NCT05019300
NCT05019300
Unknown
Not Applicable

Long-term Neurocognitive and Psychiatric Consequences of COVID-19 in Patients Discharged From Critical Care Units. A Cohort Study of the Advance Interdisciplinary Rehabilitation Register (AIRR) Covid-19 Working Group.

Pontificia Universidad Catolica de Chile1 site in 1 country80 target enrollmentMay 24, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Pontificia Universidad Catolica de Chile
Enrollment
80
Locations
1
Primary Endpoint
Cognitive impairment screening
Last Updated
4 years ago

Overview

Brief Summary

Long-term neurocognitive and psychiatric consequences of COVID-19 remain mostly unknown to date. It has been reported that coronaviruses cause direct central nervous system infection (Needham et al. 2020). Besides that, new or worsening cognitive impairment commonly occurs and persists in survivors of intensive care unit (ICU) stay (Hosey & Needham. 2020). The purpose of our study is to search and describe the cognitive and psychiatric long-term consequences of COVID-19 on patients who have been discharged from critical care units. This is an ambidirectional cohort study, that attempts to follow adults discharged from critical Care Units Adults due to COVID-19 up to 12 months after discharge, to evaluate the presence of cognitive impairment, linguistic and phonation function, depression, fatigue, functional gastroenterological symptoms, anxiety, or post traumatic disorder, and performance in activities of daily living and physical response to exercise as well.

Registry
clinicaltrials.gov
Start Date
May 24, 2021
End Date
October 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Constanza Caneo

Clinical Assistant Professor, C-L Psychiatrist, PI NPQCOVID, Advance Interdisciplinary Rehabilitation Register, (AIRR) Covid-19 Working group

Pontificia Universidad Catolica de Chile

Eligibility Criteria

Inclusion Criteria

  • Adults over 18 years of age who have been hospitalized at critical care units, who were admitted for a diagnosis of COVID-19 and who present a score on the MOCA® cognitive test of less than 26 points at the time of hospital discharge .

Exclusion Criteria

  • History of underlying cognitive disorder. History of underlying primary psychotic disorder. MOCA® cognitive test score greater than or equal to 26 points at the time of hospital discharge.

Outcomes

Primary Outcomes

Cognitive impairment screening

Time Frame: 12 months

Montreal Cognitive Assessment (MoCA®). Evaluation of cognitive domains (visuospatial, executive function; attention and memory; orientation; language). Min score: 0 Max score: 30 Cut-off for chilean population: \< 21 for mild cognitive impairment. \< 20 for dementia Setting: Home and online

Secondary Outcomes

  • Post Traumatic Stress Disorder(12 months)
  • Physical disability(12 months)
  • Quality of life related to health(12 months)
  • Neurological Soft Signs(12 months)
  • Pain severity(12 months)
  • Dysautonomia(12 months)
  • Fatigue(12 months)
  • Verbal fluency(12 months)
  • complex post-traumatic stress disorder(12 months)
  • irritable bowel syndrome(12 months)
  • Insomnia(12 months)
  • Cognitive performance(12 months)
  • Global functionality(12 months)
  • Anxiety(12 months)
  • Depressive syndrome(12 months)
  • Exercise endurance(12 months)
  • Muscle strength(12 months)
  • Spontaneous Speech(12 months)
  • Dyspnea(12 months)

Study Sites (1)

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