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

NCT05143333 | Completed

• 1 other identifier: IRB00271687
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19 cognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• DANA validation

  upto 6 months

Study Arms (1)

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

Interventions

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.

Post acute COVID-19

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead
• AnthroTronix, Inc.: collaborator

Study Sites (1)

Johns Hopkins Psychiatry department

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anupama Kumar, MBBS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 3, 2021
• Study Start: July 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

US (1)