The MentalPlus® for Assessment and Rehabilitation of Cognitive Function After Remission of the Symptoms of COVID-19
NCT ID: NCT04632719
Last Updated: 2024-03-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
200 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-11-08
Study Completion Date
2023-12-29
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Cognitive Impairment
Covid19
Cognitive Dysfunction
Depression, Anxiety
Quality of Life
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19
Intervention Type
DEVICE
Cognitive assessment and rehabilitation will be carried out on volunteers who have healed from COVID-19.
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.
Group Type
ACTIVE_COMPARATOR
The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19
Intervention Type
DEVICE
Cognitive assessment and rehabilitation will be carried out on volunteers who have healed from COVID-19.
Interventions
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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.
Intervention Type
DEVICE
Eligibility Criteria
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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.
Minimum Eligible Age
8 Years
Maximum Eligible Age
88 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Sao Paulo
OTHER
Sponsor Role
lead
Responsible Party
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Livia Stocco Sanches Valentin
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Livia S. Valentin, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo School of Medicine
Luiz Antonio M Cesar, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo School of Medicine
Luiz Aparecido Bortolotto, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo School of Medicine
Locations
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Livia Stocco Sanches Valentin
São Paulo, São Paulo, Brazil
Site Status
Livia Stocco Sanches Valentin
São Paulo, , Brazil
Site Status
Countries
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Brazil
References
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Other Identifiers
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MentalPlus®
Identifier Type: -
Identifier Source: org_study_id
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