跳至主要内容
临床试验/NCT05019300
NCT05019300Unknown不适用

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 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年5月24日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Cognitive impairment screening

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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 .

排除标准

  • 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.

结局指标

主要结局

Cognitive impairment screening

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Constanza Caneo

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

Pontificia Universidad Catolica de Chile

研究点 (1)

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