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

Cognitive Assessment in COVID 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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: DANA app

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.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Psychiatry department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants must have a documented pulmonary illness due to COVID and being treated in the PACT clinic. They should have access to an internet-connected electronic device (e.g., Android or iOS phone or tablet) able to use the DANA app.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Post acute COVID-19; Severity of COVID-19 will be determined based on patient classification within the PACT (Johns Hopkins Post-acute COVID-19 Team) clinic. Specifically, patients followed in the PACT-ICU clinic required ICU stays of ≥48 hours and high-flow nasal cannula/non-invasive ventilation or mechanical ventilation. Those followed in the PACT-Base clinic have less severe disease that does not necessitate ≥48 hours in the ICU but does qualify for PACT clinic referral based on either (1) ongoing pulmonary and/or rehabilitation needs at the time of hospital discharge, or (2) persistent pulmonary or functional deficits at 4-6 weeks post infection without hospitalization.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
DANA validation	● Validate DANA results against traditional neuropsychological test results collected as part of routine clinical care.	upto 6 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: AnthroTronix, Inc.
• Investigators: Principal Investigator: Anupama Kumar, MBBS, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19 cognition
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IRB00271687

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No