NCT05629897

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

December 14, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

11 months

First QC Date

November 18, 2022

Last Update Submit

November 29, 2022

Conditions

COVID-19Neuro-Degenerative DiseasePsychologicalSARS CoV 2 Infection

Keywords

Cognitive rehabilitationSARS-CoV-2COVIDLong-term memoryVerbal learningRAVLT

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Secondary Outcomes (6)

  • Subtests of the Number Key, Symbol Search and Digit Search Scale for Measuring Adult and Adolescent Intelligence (WAIS III)

    8 weeks

  • Trail Making Test (TMT)

    8 weeks

  • Verbal fluency tests

    8 weeks

  • Memory Failures Everyday-30 (MFE-30)

    8 weeks

  • Hospital Anxiety and Depression Scale (HADS Scale)

    8 weeks

  • +1 more secondary outcomes

Other Outcomes (8)

  • Age

    8 weeks

  • Sex

    8 weeks

  • Level of education attained

    8 weeks

  • +5 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Sessions of cognitive stimulation

Waiting list

NO INTERVENTION

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.

Interventions

Sessions of cognitive stimulationOTHER

40 sessions of cognitive stimulation of approximately 20 minutes duration per session are carried out, using the COPERIA platform.

Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36213, Spain

Location

Complexo Hospitalario Universitario de Ourense

Ourense, 32002, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Alejandro García Caballero, MD

CONTACT

988 38 55 00alejandro.alberto.garcia.caballero@sergas.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The investigator performing the analysis will be blinded to which group is the active intervention group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention or waiting list
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2022

First Posted

November 29, 2022

Study Start

December 14, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

December 2, 2022

Record last verified: 2022-11

Locations

ES(2)