Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 7:26 PM
Study NCT ID:
NCT05143333
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2021-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Assessment in COVID-19 Positive Patients Using the DANA App
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Cognitive Assessment in COVID Positive Patients Using the DANA App
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: