Cognitive Assessment in COVID-19 Positive Patients Using the DANA App

COVID-19 Clinical Trial

Official title:

Cognitive Assessment in COVID Positive Patients Using the DANA App

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05143333
• Other study ID #: IRB00271687
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• DANA app
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 their own homes without examiner supervision. Hence, the DANA battery bypasses several of the major limitations associated with in-person cognitive exams.

Locations

Country	Name	City	State
United States	Johns Hopkins Psychiatry department	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	AnthroTronix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive dysfunction trajectory	? 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.	upto 6 months
Secondary	DANA validation	? Validate DANA results against traditional neuropsychological test results collected as part of routine clinical care.	upto 6 months