Clinical trial NCT04632719: The MentalPlus® for Assessment and Rehabilitation of Cognitive Function After Remission of the Symptoms of COVID-19
Official title: MentalPlus® for Assessment and Rehabilitation of Cognitive Functions After Remission of Symptoms of COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Covid19
Cognitive Dysfunction
Depression, Anxiety
Quality of Life
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 88
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assessment of cognitive functions after COVID-19
timeFrame: 1 year
Secondary outcomes:
measure: Rehabilitation of cognitive functions after COVID-19
timeFrame: 1 year
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Livia Stocco Sanches Valentin
state: SP
city: Sao Paulo
country: Brazil
facility: Livia Stocco Sanches Valentin
Study officials:
affiliation: University of Sao Paulo School of Medicine
name: Livia S. Valentin, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo School of Medicine
name: Luiz Antonio M Cesar, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo School of Medicine
name: Luiz Aparecido Bortolotto, Ph.D
role: PRINCIPAL_INVESTIGATOR
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