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Computer Cognitive Training for Post-acute COVID-19 Syndrome (PACS-Cog)

Primary Purpose

Corona Virus Infection, Cognitive Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training
Sponsored by
Nova Southeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corona Virus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Persons with a history of COVID-19 infection confirmed through screening of symptom pattern or testing and report of mental symptoms (difficulties in attention, memory, or executive functions such as coordinating two activities at once) more than 30 days after resolution of the initial acute infection.

Exclusion Criteria:

  • Cognitive or psychiatric conditions of a severity that precludes the person's ability to give informed consent for their participation or to attend and cooperate with assessment and training, as judged by the investigators.

Sites / Locations

  • Center for Collaborative Research, Nova Southeastern UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive Training

Arm Description

Participants in this condition will received game-based cognitive training.

Outcomes

Primary Outcome Measures

Technology Acceptance Model Questionnaire, Usefulness subscale
User self-report of their perception that an application serves a function that may be helpful The score is the average of several items rated by the user from 0 to 6, so that the final score itself can range from 0 to 6. Higher scores indicate that the user found the intervention more useful. Higher scores are better.

Secondary Outcome Measures

Cognitive Failures Questionnaire
A standard self-report measure of problems in memory, attention, and self-regulated behavior. This measures includes self-report ratings on 25 items, with ratings ranging from 0 to 4. The total score can thus range from 0 to 100, with higher scores indicating that the person experiences more problems with thinking and remembering.
Trail Making Test, Part B
This is a measure of how rapidly a person can remember alternating sequences of numbers and letters while connecting them on a paper with a pencil. The score is time in seconds to complete the task, with the provision that if a person cannot finish the task within three minutes, the task is discontinued and the person is assigned a score of 180 (for 3 minutes times 60 seconds). Lower scores indicate better performance.

Full Information

First Posted
April 14, 2022
Last Updated
July 10, 2023
Sponsor
Nova Southeastern University
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1. Study Identification

Unique Protocol Identification Number
NCT05338749
Brief Title
Computer Cognitive Training for Post-acute COVID-19 Syndrome
Acronym
PACS-Cog
Official Title
An Open-label Trial of Computer-delivered Cognitive Training in Persons With Post-acute COVID-19 Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Southeastern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will assess the acceptability, feasibility, and impact of game-based computer-delivered cognitive training on cognitive function in persons with cognitive symptoms that persist after recovery from acute coronavirus-19 (COVID) infection.
Detailed Description
Over the course of the past several years, it has become apparent that a number of individuals have residual symptoms after COVID-19 infection after they have recovered from the acute phase of the illness (Al-Aly, Xie, & Bowe, 2021; Davis et al., 2021; Greenhalgh, Knight, A'Court, Buxton, & Husain, 2020; Hewitt et al., 2021). The constellation of symptoms experienced by these individuals has been termed "post-acute COVID syndrome" or PACS (Nalbandian et al., 2021). A key part of helping affected individuals is supporting their efforts at self-management of these symptoms (National Institute for Health and Care Excellence, 2020; Wade, 2020). Although a diverse number of physical and psychological symptoms have been seen as sequelae of COVID (Davis et al., 2021), among the most troubling for patients have been difficulties in attention, concentration, working memory, and long-term memory, commonly referred to as "brain fog" (Graham et al., 2021; Hampshire et al., 2021; Hewitt et al., 2021). In the proposed study, we will complete a pilot study of game-based cognitive training in persons with symptoms of long COVID using a protocol that was useful and acceptable to participants in a previous study (Ownby & Kim, 2021). We will explore participants' views on the cognitive training intervention, its effects on their perceived cognitive functioning, and assess the intervention's impact on participants' processing speed. We will also explore their preferences for type of cognitive training activity and the impact of information about memory functioning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Infection, Cognitive Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open label
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Training
Arm Type
Experimental
Arm Description
Participants in this condition will received game-based cognitive training.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
Gamified cognitive training intervention to improve mental speed and attention.
Primary Outcome Measure Information:
Title
Technology Acceptance Model Questionnaire, Usefulness subscale
Description
User self-report of their perception that an application serves a function that may be helpful The score is the average of several items rated by the user from 0 to 6, so that the final score itself can range from 0 to 6. Higher scores indicate that the user found the intervention more useful. Higher scores are better.
Time Frame
Three weeks
Secondary Outcome Measure Information:
Title
Cognitive Failures Questionnaire
Description
A standard self-report measure of problems in memory, attention, and self-regulated behavior. This measures includes self-report ratings on 25 items, with ratings ranging from 0 to 4. The total score can thus range from 0 to 100, with higher scores indicating that the person experiences more problems with thinking and remembering.
Time Frame
Three weeks
Title
Trail Making Test, Part B
Description
This is a measure of how rapidly a person can remember alternating sequences of numbers and letters while connecting them on a paper with a pencil. The score is time in seconds to complete the task, with the provision that if a person cannot finish the task within three minutes, the task is discontinued and the person is assigned a score of 180 (for 3 minutes times 60 seconds). Lower scores indicate better performance.
Time Frame
Three weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Persons with a history of COVID-19 infection confirmed through screening of symptom pattern or testing and report of mental symptoms (difficulties in attention, memory, or executive functions such as coordinating two activities at once) more than 30 days after resolution of the initial acute infection. Exclusion Criteria: Cognitive or psychiatric conditions of a severity that precludes the person's ability to give informed consent for their participation or to attend and cooperate with assessment and training, as judged by the investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond L Ownby, MD, PhD
Phone
954-262-1481
Email
ro71@nova.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rosemary Davenport, ARNP
Phone
954-262-1804
Email
bap2@bellsouth.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond L Ownby, MD, PhD
Organizational Affiliation
Nova Southeastern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Collaborative Research, Nova Southeastern University
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosemary Davenport, MSN, ARNP
Phone
954-262-1804
Email
bap2@bellsouth.net
First Name & Middle Initial & Last Name & Degree
Raymond L Ownby, MD, PhD
Phone
9542621481
Email
ro71@nova.edu
First Name & Middle Initial & Last Name & Degree
Raymond L Ownby, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data sharing plan
IPD Sharing Time Frame
After completion of study
IPD Sharing Access Criteria
On request from any qualified investigator.
Citations:
PubMed Identifier
34867291
Citation
Ownby RL, Kim J. Computer-Delivered Cognitive Training and Transcranial Direct Current Stimulation in Patients With HIV-Associated Neurocognitive Disorder: A Randomized Trial. Front Aging Neurosci. 2021 Nov 15;13:766311. doi: 10.3389/fnagi.2021.766311. eCollection 2021.
Results Reference
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Computer Cognitive Training for Post-acute COVID-19 Syndrome

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