COPERIA-COGRandomised Clinical Trial to Evaluate the Efficacy of an Online Cognitive Rehabilitation Programme (COPERIA-COG) for Patients With Persistent COVID-19
Sessions of cognitive stimulation
COVID-19+9
+ Infections à Coronaviridae
+ Infections
Étude thérapeutique
Résumé
Date de début de l'étude : 14 décembre 2022
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.88 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 70 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 2 sites
Complexo Hospitalario Universitario de Ourense
Ourense, SpainOuvrir Complexo Hospitalario Universitario de Ourense dans Google MapsGalicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro
Vigo, Spain