The MentalPlus® for Assessment and Rehabilitation of Cognitive Function After Remission of the Symptoms of COVID-19 (MP-COVID)

March 5, 2024 updated by: Livia Stocco Sanches Valentin, University of Sao Paulo

MentalPlus® for Assessment and Rehabilitation of Cognitive Functions After Remission of Symptoms of COVID-19

This study evaluates and rehabilitates the cognitive functions of attention, memory, visual perception, language, and executive by the mentalPlus® digital game of COVID-19 surviving patients after remission of symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects who contracted COVID-19 and present remission of symptoms will be studied, with different age groups, illiterate or literate, of both genders and with different socio-demographic characteristics. The volunteers will be submitted to the application of MentalPlus® to assess cognitive functions and SF-8® to assess Quality of Life.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 02019010
        • Livia Stocco Sanches Valentin
    • SP
      • São Paulo, SP, Brazil, 02019-010
        • Livia Stocco Sanches Valentin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 84 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients affected by COVID-19 with or without comorbidity for cardiovascular diseases, diabetes mellitus, hypertension, cancer, asthma between the ages of 8 and 88 years of both sexes and illiterate or literate.

Exclusion Criteria:

  • Disability for the instrument's use: limitation for the mobility of the upper limbs, presence of significant mental retardation that compromises the understanding of the instructions for the use of MentalPlus®, significant lowering of visual acuity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Covid-19 Study Group
The Study Group will be the group that was remiss for COVID-19 and has some of the mentioned comorbidities as asthma, cardiovascular disease, cancer even if controlled by drugs or treatments.
Device: The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19
Cognitive assessment and rehabilitation will be carried out on volunteers who have healed from COVID-19.
Active Comparator: Covid-19 Control Group
The Control Group will be the group with remissive patients without the aforementioned comorbidities. We will assess whether comorbidities can worsen cognitive functions' impairment after the remission of the symptoms of COVID-19.
Device: The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19
Cognitive assessment and rehabilitation will be carried out on volunteers who have healed from COVID-19.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of cognitive functions after COVID-19
Time Frame: 1 year
The evaluation of cognitive functions by the digital game MentalPlus® (a scale of assessment and cognitive rehabilitation) will take place as follows: Scores range from 0 [Not improved] to 10 [fully improved] at cognitive functions memory, attention and executive after training with Scale. This game is already validated and standardized for the global population. The test takes 25 minutes to play, is playful and self-explanatory. It has twelve themes with cognitive functions: short and long-term memory; selective, alternate and concentrated attention, inhibitory control of executive function and visual perception. MentalPlus® is completely randomized in its phases and themes. Therefore, the game can be used for cognitive assessment with a single theme (25 minutes of execution) or rehabilitation on 10 more themes and a final theme for reassessment of cognitive functions.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rehabilitation of cognitive functions after COVID-19
Time Frame: 1 year
Rehabilitation of cognitive functions: executive, attention, memory, visual perception, language, after the remission of the symptoms of COVID-19. MentalPlus® will be used in order to rehabilitate the cognitive functions of patients who have dysfunctions after COVID-19. The patient will play on alternate days (every other day) a theme of the game and will be rehabilitated through its 10 themes. At the end of these 10 themes, the patient will be reassessed by the last theme of the game, comprising a total of 12 themes. Each theme lasts for 25 minutes each.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Livia S. Valentin, Ph.D, University of Sao Paulo School of Medicine
  • Principal Investigator: Luiz Antonio M Cesar, Ph.D, University of Sao Paulo School of Medicine
  • Principal Investigator: Luiz Aparecido Bortolotto, Ph.D, University of Sao Paulo School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2020

Primary Completion (Actual)

December 29, 2020

Study Completion (Actual)

December 29, 2023

Study Registration Dates

First Submitted

November 14, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MentalPlus®

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study will be shared with researchers from international centers. Therefore, the information will be made available between centers so that everyone can follow the same research protocol.

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

Access will be made available by MentalPlus® APP and email.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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