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Completed

NCT Number: NCT05143333

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Psychiatry department

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

DANA app

Other

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.

Primary outcomes

  1. Cognitive dysfunction trajectory

    Time frame: 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.

Secondary outcomes

  1. DANA validation

    Time frame: upto 6 months

    ● Validate DANA results against traditional neuropsychological test results collected as part of routine clinical care.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • AnthroTronix, Inc.

Registry information

Official study title

Cognitive Assessment in COVID Positive Patients Using the DANA App

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 3, 2021
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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