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临床试验/NCT05143333
NCT05143333已完成不适用

Cognitive Assessment in COVID Positive Patients Using the DANA App

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Cognitive dysfunction trajectory

研究概览

简要总结

The Defense Automated Neurobehavioral Assessment (DANA) is a battery of cognitive tests delivered via an electronic tablet or smartphone. The overarching goal of this study is to evaluate the post-acute trajectory of cognitive functioning in patients hospitalized for COVID-19 using the DANA.

详细描述

The sequelae of COVID-19 are increasingly appreciated to be systemic and persistent among certain populations. Retrospective review of severe COVID-19 cases revealed increased altered mental status, encephalitis, psychosis, and neurocognitive abnormalities in the three weeks following discharge. During severe COVID-19 infection, there is additional evidence of cerebrovascular events, including ischemic stroke and intracerebral hemorrhage. The most common long-term neurological sequelae are loss of taste/smell, headache, and vertigo. However, there is additional evidence for cognitive impairment among those with severe COVID-19, with 33% of patients discharged from one intensive care unit (ICU) exhibiting clinically relevant inattention, disorientation, and poorly organized movements. Another study utilizing a three-week telephone cognitive screening four weeks after discharge showed that 42% of those who experienced delirium during ICU stay had lasting lower cognitive scores compared to those who did not experience delirium.

The majority of currently available knowledge about neurocognitive symptoms associated with COVID-19 comes from cross-sectional studies of patients in the acute setting. Existing data suggests that following hospitalization, COVID-19 survivors may most frequently demonstrate deficits in letter-cued verbal fluency and executive function. However, this body of research is in its early stages and further investigation is needed. The model of traditional face-to-face cognitive testing using paper and pencil instruments is poorly suited to a global infectious disease pandemic. The Defense Automated Neurobehavioral Assessment (DANA) is a battery of cognitive tests delivered via an electronic tablet or smartphone. The platform allows higher temporal precision and frequency of measurement than traditional neuropsychological methods while including previously standardized cognitive tests and allowing individuals to repeatedly self-administer the battery in the individuals' own homes without examiner supervision. Hence, the DANA battery bypasses several of the major limitations associated with in-person cognitive exams.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have documented pulmonary illness treated in the PACT clinic.
  • Have access to an internet-connected electronic device (e.g., Android or iOS phone or tablet) able to perform DANA.
  • Agree to participate in seven DANA assessments.
  • Be proficient in use of the English language.
  • Willing and able to consent to the study.

排除标准

  • During the testing phase, plans to undergo treatment with documented lasting neurocognitive effects that will confound DANA assessments, including but not limited to: neurosurgery, chemotherapy, radiation therapy, electroconvulsive therapy, and cardiac surgery.
  • During the testing phase, sustains injury or disease state unrelated to reason for PACT admission with documented lasting neurocognitive effects that will confound DANA assessments, including but not limited to: traumatic brain injury (as determined by study clinician).

结局指标

主要结局

Cognitive dysfunction trajectory

时间窗: upto 6 months

● Characterize the nature (i.e., pattern of cognitive deficits) and trajectory of cognitive dysfunction among those treated for COVID-19 with high temporal resolution repeatedly for up to 6 months using the DANA.

次要结局

  • DANA validation(upto 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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