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Randomised Clinical Trial to Evaluate the Efficacy of an Online Cognitive Rehabilitation Programme (COPERIA-COG) for Patients With Persistent COVID-19 (COPERIA-COG)

Primary Purpose

COVID-19, Neuro-Degenerative Disease, Psychological

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Sessions of cognitive stimulation
Sponsored by
Fundacin Biomedica Galicia Sur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Cognitive rehabilitation, SARS-CoV-2, COVID, Long-term memory, Verbal learning, RAVLT

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 and ≤70 years old. Read and write. Diagnosis of persistent COVID according to WHO criteria. The patient reports cognitive dysfunction with self-assessed impact of at least grade 2 on the Post-Covid Functional Status (Chile) (Klok et al., 2020, Lorca et al., 2021). The patient does not present cognitive dysfunction to a degree equal to or greater than 1.5 SD assessed in the psychology consultation by means of the following instruments: RAVLT Rey Auditory Verbal Learning Test (Schmidt, 1996). Subtests of the Number Key, Symbol Search and Digit Span of the Scale for Measuring Adult and Adolescent Intelligence (WAIS III) (Wechsler, 1999). TMT Stroke Test (Reitan & Wolfson, 1993). Verbal fluency tests (Benton et al., 1989). In case of scores above 1.5 SD below the normative mean, they will be excluded from the study and referred for treatment to the Brain Injury Unit (Winblad et al., 2004). Patients with capacity to consent and agree to participate in the study. Patients who know how to use and have a Smartphone or Tablet and an Internet connection. Exclusion Criteria: Minors or persons legally incapacitated. Previous neurological or psychiatric pathology involving neuropsychological compromise. Active Covid19 infection. Home oxygen therapy > 16 hours or home CPAP-BiPAP. Be undergoing another cognitive rehabilitation process at the time of inclusion.

Sites / Locations

  • Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro
  • Complexo Hospitalario Universitario de Ourense

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Waiting list

Arm Description

They will perform an initial test of processing speed, attentional span and executive control. After this test, they will start the training programme. It consists of 40 sessions of cognitive stimulation, distributed over 8 weeks of treatment with a frequency of five sessions per week. In the last session, a final test will be performed, the same as the initial one.

They will perform an initial test of processing speed, attentional span and executive control. In the last session, 8 weeks after the initial test, a final test will be performed, the same as the initial one. They will have the opportunity to perform the same training as the experimental group after performing the final test. At 8 weeks, patients on the waiting list will be taught, if the wish, how to use the platform to perform the stimulation. They will be offered cognitive training with COPERIA-COG under the same conditions, periodicity, automatic reminders and calls from the psychologist as in the intervention group.

Outcomes

Primary Outcome Measures

RAVLT Rey Auditory Verbal Learning Test
An instrument that has proven useful in assessing verbal learning and memory. Easily administered test that assesses immediate memory span, new learning, susceptibility to interference and recognition memory.

Secondary Outcome Measures

Subtests of the Number Key, Symbol Search and Digit Search Scale for Measuring Adult and Adolescent Intelligence (WAIS III)
They allow the calculation of the processing speed index. The Spanish adaptation of the WAIS-III was used. Reliability coefficients (two halves) range from .77 to .96.
Trail Making Test (TMT)
The test consists of two parts, A and B. Part A assesses sustained attention, processing speed, motor skills and visuospatial visual search skills. Part B assesses alternating attention and cognitive flexibility. Its reliability is between 0.86% and 0.94% and its reliability is .66. Neuronorm scales are used in Spain
Verbal fluency tests
The investigators will use the phonemic fluency test, a task of oral production of words before phonetic commands (P-M-R) and the semantic fluency test (animals), a task of linguistic production that requires the implementation of the mechanisms of access to the lexicon. Neuronorm scales are used in Spain. The scale is made with scalar scores from 2 to 18, where 2 is the worst score and 18 is the best.
Memory Failures Everyday-30 (MFE-30)
It is a 30-item questionnaire that explores the relationships between the occurrence of memory complaints, prefrontal symptomatology and perceived stress. The scale has values between 0-120. Where 120 is indicative of more severe impairment in daily functioning and 0 indicates optimal functioning.
Hospital Anxiety and Depression Scale (HADS Scale)
The Hospital Anxiety and Depression Scale was originally designed as a screening instrument for the detection of patients with affective disorders in response to the drawbacks of widely used instruments such as the GHQ. It consists of two sets of seven items -one representing the anxiety subscale and the other the depression subscale- both of which are psychopathological concepts of anxiety and depression independent. There are two subscales (anxiety and depression) with a score from 0 to 21 each. Scores greater than 10 are considered indicative of morbidity, scores between 8-10 are considered bordeline and scores less than 8 indicate no significant morbidity.
Adherence to online treatment
Number of games played and total time of use will be extracted from the platform, analysing whether there are differences by age or gender or severity.

Full Information

First Posted
November 18, 2022
Last Updated
November 29, 2022
Sponsor
Fundacin Biomedica Galicia Sur
Collaborators
Centro de Investigación Biomédica en Red de Salud Mental, Galician South Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05629897
Brief Title
Randomised Clinical Trial to Evaluate the Efficacy of an Online Cognitive Rehabilitation Programme (COPERIA-COG) for Patients With Persistent COVID-19
Acronym
COPERIA-COG
Official Title
Randomised Clinical Trial to Evaluate the Efficacy of an Online Cognitive Rehabilitation Programme (COPERIA-COG) for Patients With Persistent COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 14, 2022 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacin Biomedica Galicia Sur
Collaborators
Centro de Investigación Biomédica en Red de Salud Mental, Galician South Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The pandemic caused by SARS-CoV-2 infection has led to the emergence of diffuse and heterogeneous persistent symptoms in addition to the well-known acute symptoms, which have come to be referred to as persistent COVID. In particular, one of the frequent complaints of patients with a previous diagnosis of COVID is impaired cognitive ability. Various cognitive rehabilitation programmes have benefited from incorporating the methodology of so-called "serious games" are designed to train or change behaviour while entertaining players. The design of the online rehabilitation programme (COPERIA-COG) took into account the principles of neuropsychological rehabilitation (neuropsychological pre-assessment, operational goal setting, task prioritisation and continuous feedback system) and combined different individual techniques, such as restitution and compensation. Patients treated with COPERIA-COG will show neuropsychological improvements in verbal memory compared to the waiting list group. The main objective is to identify differences in long-term memory in patients treated with COPERIA-COG vs. patients on the waiting list. For this purpose, both groups will be evaluated through RAVLT, taking the long-term memory subtest as a reference, comparing the results before and after the active group performs the online training with COPERIA-COG. The COPERIA platform is a cloud platform that provides a range of ICT tools for monitoring and aiding the recovery of patients with persistent COVID. To achieve this goal, the platform will store patient data to which Artificial Intelligence techniques will be applied to perform an assessment of the affected person.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Neuro-Degenerative Disease, Psychological, SARS CoV 2 Infection
Keywords
Cognitive rehabilitation, SARS-CoV-2, COVID, Long-term memory, Verbal learning, RAVLT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention or waiting list
Masking
Outcomes Assessor
Masking Description
The investigator performing the analysis will be blinded to which group is the active intervention group.
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
They will perform an initial test of processing speed, attentional span and executive control. After this test, they will start the training programme. It consists of 40 sessions of cognitive stimulation, distributed over 8 weeks of treatment with a frequency of five sessions per week. In the last session, a final test will be performed, the same as the initial one.
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
They will perform an initial test of processing speed, attentional span and executive control. In the last session, 8 weeks after the initial test, a final test will be performed, the same as the initial one. They will have the opportunity to perform the same training as the experimental group after performing the final test. At 8 weeks, patients on the waiting list will be taught, if the wish, how to use the platform to perform the stimulation. They will be offered cognitive training with COPERIA-COG under the same conditions, periodicity, automatic reminders and calls from the psychologist as in the intervention group.
Intervention Type
Other
Intervention Name(s)
Sessions of cognitive stimulation
Intervention Description
40 sessions of cognitive stimulation of approximately 20 minutes duration per session are carried out, using the COPERIA platform.
Primary Outcome Measure Information:
Title
RAVLT Rey Auditory Verbal Learning Test
Description
An instrument that has proven useful in assessing verbal learning and memory. Easily administered test that assesses immediate memory span, new learning, susceptibility to interference and recognition memory.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Subtests of the Number Key, Symbol Search and Digit Search Scale for Measuring Adult and Adolescent Intelligence (WAIS III)
Description
They allow the calculation of the processing speed index. The Spanish adaptation of the WAIS-III was used. Reliability coefficients (two halves) range from .77 to .96.
Time Frame
8 weeks
Title
Trail Making Test (TMT)
Description
The test consists of two parts, A and B. Part A assesses sustained attention, processing speed, motor skills and visuospatial visual search skills. Part B assesses alternating attention and cognitive flexibility. Its reliability is between 0.86% and 0.94% and its reliability is .66. Neuronorm scales are used in Spain
Time Frame
8 weeks
Title
Verbal fluency tests
Description
The investigators will use the phonemic fluency test, a task of oral production of words before phonetic commands (P-M-R) and the semantic fluency test (animals), a task of linguistic production that requires the implementation of the mechanisms of access to the lexicon. Neuronorm scales are used in Spain. The scale is made with scalar scores from 2 to 18, where 2 is the worst score and 18 is the best.
Time Frame
8 weeks
Title
Memory Failures Everyday-30 (MFE-30)
Description
It is a 30-item questionnaire that explores the relationships between the occurrence of memory complaints, prefrontal symptomatology and perceived stress. The scale has values between 0-120. Where 120 is indicative of more severe impairment in daily functioning and 0 indicates optimal functioning.
Time Frame
8 weeks
Title
Hospital Anxiety and Depression Scale (HADS Scale)
Description
The Hospital Anxiety and Depression Scale was originally designed as a screening instrument for the detection of patients with affective disorders in response to the drawbacks of widely used instruments such as the GHQ. It consists of two sets of seven items -one representing the anxiety subscale and the other the depression subscale- both of which are psychopathological concepts of anxiety and depression independent. There are two subscales (anxiety and depression) with a score from 0 to 21 each. Scores greater than 10 are considered indicative of morbidity, scores between 8-10 are considered bordeline and scores less than 8 indicate no significant morbidity.
Time Frame
8 weeks
Title
Adherence to online treatment
Description
Number of games played and total time of use will be extracted from the platform, analysing whether there are differences by age or gender or severity.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Age
Description
Years
Time Frame
8 weeks
Title
Sex
Description
Male, Female
Time Frame
8 weeks
Title
Level of education attained
Description
School, High school, College, Superior
Time Frame
8 weeks
Title
Employment status
Description
Employed, unemployed, retired
Time Frame
8 weeks
Title
Current treatment
Description
Treatment taken by the patient at the time of the study.
Time Frame
8 weeks
Title
Date of the SARS-CoV-2 PCR+
Description
DD-MMM-YYYY
Time Frame
8 weeks
Title
Epidemic wave
Description
Of the 7 waves of COVID-19 that have occurred in Spain, a description will be given of the wave to which the infection of each patient included belonged. First, second, third, fourth, fifth, sixth, seventh, eighth, ninth or tenth wave.
Time Frame
8 weeks
Title
Vaccination status at the time of infection
Description
Number of vaccine doses at the time of infection
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 and ≤70 years old. Read and write. Diagnosis of persistent COVID according to WHO criteria. The patient reports cognitive dysfunction with self-assessed impact of at least grade 2 on the Post-Covid Functional Status (Chile) (Klok et al., 2020, Lorca et al., 2021). The patient does not present cognitive dysfunction to a degree equal to or greater than 1.5 SD assessed in the psychology consultation by means of the following instruments: RAVLT Rey Auditory Verbal Learning Test (Schmidt, 1996). Subtests of the Number Key, Symbol Search and Digit Span of the Scale for Measuring Adult and Adolescent Intelligence (WAIS III) (Wechsler, 1999). TMT Stroke Test (Reitan & Wolfson, 1993). Verbal fluency tests (Benton et al., 1989). In case of scores above 1.5 SD below the normative mean, they will be excluded from the study and referred for treatment to the Brain Injury Unit (Winblad et al., 2004). Patients with capacity to consent and agree to participate in the study. Patients who know how to use and have a Smartphone or Tablet and an Internet connection. Exclusion Criteria: Minors or persons legally incapacitated. Previous neurological or psychiatric pathology involving neuropsychological compromise. Active Covid19 infection. Home oxygen therapy > 16 hours or home CPAP-BiPAP. Be undergoing another cognitive rehabilitation process at the time of inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro García Caballero, MD
Phone
988 38 55 00
Email
alejandro.alberto.garcia.caballero@sergas.es
Facility Information:
Facility Name
Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36213
Country
Spain
Facility Name
Complexo Hospitalario Universitario de Ourense
City
Ourense
ZIP/Postal Code
32002
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro García Caballero, MD
Email
alejandro.alberto.garcia.caballero@sergas.es
First Name & Middle Initial & Last Name & Degree
Alejandro García Caballero, MD
First Name & Middle Initial & Last Name & Degree
María Bustillo Casado, MD
First Name & Middle Initial & Last Name & Degree
María Dolores Díaz López, MD
First Name & Middle Initial & Last Name & Degree
Pablo López Mato, MD
First Name & Middle Initial & Last Name & Degree
Luis Docasar Bertolo, MD
First Name & Middle Initial & Last Name & Degree
Beatriz Gómez Gómez, MD

12. IPD Sharing Statement

Learn more about this trial

Randomised Clinical Trial to Evaluate the Efficacy of an Online Cognitive Rehabilitation Programme (COPERIA-COG) for Patients With Persistent COVID-19

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