Clinical trial NCT05629897: Randomised Clinical Trial to Evaluate the Efficacy of an Online Cognitive Rehabilitation Programme (COPERIA-COG) for Patients With Persistent COVID-19
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
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Neuro-Degenerative Disease
Psychological
SARS CoV 2 Infection
Keywords: Cognitive rehabilitation
SARS-CoV-2
COVID
Long-term memory
Verbal learning
RAVLT
Lead sponsor: Fundacin Biomedica Galicia Sur
Sponsor class: OTHER
Collaborators: name: Centro de Investigación Biomédica en Red de Salud Mental
name: Galician South Health Research Institute
First posted: 2022-11-29
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention or waiting list
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: RAVLT Rey Auditory Verbal Learning Test
timeFrame: 8 weeks
Secondary outcomes:
measure: Subtests of the Number Key, Symbol Search and Digit Search Scale for Measuring Adult and Adolescent Intelligence (WAIS III)
timeFrame: 8 weeks
measure: Trail Making Test (TMT)
timeFrame: 8 weeks
measure: Verbal fluency tests
timeFrame: 8 weeks
measure: Memory Failures Everyday-30 (MFE-30)
timeFrame: 8 weeks
measure: Hospital Anxiety and Depression Scale (HADS Scale)
timeFrame: 8 weeks
measure: Adherence to online treatment
timeFrame: 8 weeks
Other outcomes:
measure: Age
timeFrame: 8 weeks
measure: Sex
timeFrame: 8 weeks
measure: Level of education attained
timeFrame: 8 weeks
measure: Employment status
timeFrame: 8 weeks
measure: Current treatment
timeFrame: 8 weeks
measure: Date of the SARS-CoV-2 PCR+
timeFrame: 8 weeks
measure: Epidemic wave
timeFrame: 8 weeks
measure: Vaccination status at the time of infection
timeFrame: 8 weeks
Locations:
city: Vigo
country: Spain
facility: Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro
state: Pontevedra
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
Study officials:
References: