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

NCT ID: NCT05629897

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-14
• Study Completion Date: 2023-11-30

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.

Conditions

COVID-19; Neuro-Degenerative Disease; Psychological; SARS CoV 2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Sessions of cognitive stimulation

Intervention Type: OTHER

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

Waiting list

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sessions of cognitive stimulation

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 and ≤70 years old.

2. Read and write.

3. Diagnosis of persistent COVID according to WHO criteria.

4. 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).

5. 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).

6. Patients with capacity to consent and agree to participate in the study.

7. Patients who know how to use and have a Smartphone or Tablet and an Internet connection.

Exclusion Criteria

1. Minors or persons legally incapacitated.

2. Previous neurological or psychiatric pathology involving neuropsychological compromise.

3. Active Covid19 infection.

4. Home oxygen therapy > 16 hours or home CPAP-BiPAP.

5. Be undergoing another cognitive rehabilitation process at the time of inclusion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro de Investigación Biomédica en Red de Salud Mental

NETWORK

Sponsor Role: collaborator

Galician South Health Research Institute

NETWORK

Sponsor Role: collaborator

Fundacin Biomedica Galicia Sur

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Vigo, Pontevedra, Spain

Complexo Hospitalario Universitario de Ourense

Ourense, , Spain

Countries

Spain

Central Contacts

Alejandro García Caballero, MD

Role: CONTACT

alejandro.alberto.garcia.caballero@sergas.es

988 38 55 00

Facility Contacts

Alejandro García Caballero, MD

Role: primary

alejandro.alberto.garcia.caballero@sergas.es

Other Identifiers

COPERIA-COG

Identifier Type: -

Identifier Source: org_study_id