NCT05338749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

April 26, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

1.6 years

First QC Date

April 14, 2022

Last Update Submit

March 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Three weeks

Secondary Outcomes (2)

  • Cognitive Failures Questionnaire

    Three weeks

  • Trail Making Test, Part B

    Three weeks

Study Arms (1)

Cognitive Training

EXPERIMENTAL

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

Behavioral: Cognitive Training

Interventions

Gamified cognitive training intervention to improve mental speed and attention.

Cognitive Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Collaborative Research, Nova Southeastern University

Fort Lauderdale, Florida, 33314, United States

Location

Related Publications (1)

  • 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.

    PMID: 34867291BACKGROUND

MeSH Terms

Conditions

Coronavirus InfectionsCognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Raymond L Ownby, MD, PhD

    Nova Southeastern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 21, 2022

Study Start

April 26, 2022

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

March 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Data sharing plan

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After completion of study
Access Criteria
On request from any qualified investigator.

Locations