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

Primary Purpose

Cognitive Impairment, Covid19, Cognitive Dysfunction

Status

Recruiting

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19

About this trial

This is an interventional treatment trial for Cognitive Impairment

Eligibility Criteria

8 Years - 88 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Livia Stocco Sanches ValentinRecruiting
Livia Stocco Sanches ValentinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Covid-19 Study Group

Covid-19 Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Assessment of cognitive functions after COVID-19

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.

Secondary Outcome Measures

Rehabilitation of cognitive functions after COVID-19

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.

Full Information

NCT ID

NCT04632719

First Posted

November 14, 2020

Last Updated

November 16, 2020

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT04632719

Brief Title

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

Acronym

MP-COVID

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Recruiting

Study Start Date

November 8, 2020 (Actual)

Primary Completion Date

December 29, 2020 (Anticipated)

Study Completion Date

December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Impairment, Covid19, Cognitive Dysfunction, Depression, Anxiety, Quality of Life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The study has two groups. The Study Group will be the group that was remissive for COVID-19 and has some of the mentioned comorbidities, even if controlled by drugs or treatments. The Control Group will be the group with remissive patients without the aforementioned comorbidities. We will assess whether comorbidities can worsen the impairment of cognitive functions after the remission of the symptoms of COVID-19. The purpose of the research is to verify; whether COVID-19 alone in moderate to severe cases causes cognitive impairment or whether predisposing factors for such comorbidities would cause further impairment in cognitive functions after COVID-19 contraction and remission.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Covid-19 Study Group

Arm Type

Experimental

Arm Description

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.

Arm Title

Covid-19 Control Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19

Intervention Description

Cognitive assessment and rehabilitation will be carried out on volunteers who have healed from COVID-19.

Primary Outcome Measure Information:

Title

Assessment of cognitive functions after COVID-19

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Rehabilitation of cognitive functions after COVID-19

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

88 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Livia S. Valentin, Ph.D.

Phone

+5511999959215

lssv@usp.br; livia.valentin@hc.fm.usp.br; dra.liviavalentin@gmail.com.br

First Name & Middle Initial & Last Name or Official Title & Degree

Julia S. Valentin, Fellow

Phone

+5511971958165

jssvtocco@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Livia S. Valentin, Ph.D

Organizational Affiliation

University of Sao Paulo School of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Luiz Antonio M Cesar, Ph.D

Organizational Affiliation

University of Sao Paulo School of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Luiz Aparecido Bortolotto, Ph.D

Organizational Affiliation

University of Sao Paulo School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Livia Stocco Sanches Valentin

City

São Paulo

State/Province

ZIP/Postal Code

02019-010

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Livia Stocco S Valentin, Ph.D

Phone

+5511999959215

lssv@usp.br

First Name & Middle Initial & Last Name & Degree

Julia S Valentin, Fellow

Phone

+5511971958165

jssvtocco@gmail.com

First Name & Middle Initial & Last Name & Degree

Luiz Antonio M Cesar, Ph.D

First Name & Middle Initial & Last Name & Degree

Luiz Aparecido Bortolotto, Ph.D

Facility Name

Livia Stocco Sanches Valentin

City

Sao Paulo

ZIP/Postal Code

02019010

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Livia SS Valentin, Ph.D

Phone

+5511999959215

lssv@usp.br

First Name & Middle Initial & Last Name & Degree

Julia SS Valentin, Bacharel

Phone

+5511971958165

jssvtocco@gmail.com

First Name & Middle Initial & Last Name & Degree

Luiz Antonio M Cesar, Ph.D

First Name & Middle Initial & Last Name & Degree

Luiz Aparecido Bortolotto, Ph.D

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

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

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