The goal of this study is to determine whether the SuperCAP intervention program is superior to control in reducing disability from baseline to the post-intervention assessment in people with Post-COVID-19 Condition.
The main question it aims to answer is whether participants assigned to SuperCAP experience a greater reduction in disability, defined as an improvement of at least 5 points on the WHODAS 2.0 from baseline to the post-intervention visit, compared with participants in the control group.
Participants assigned to the SuperCAP intervention will undergo a series of sessions that include psychoeducation, adaptive cognitive training exercises, fatigue self-management strategies, and multidisciplinary content.
Diagnosis of PCC, defined as the presence of three or more symptoms associated with COVID-19 infection for at least three months, not explained by other diseases.
Age 18 to 65 years.
Willingness to participate in an app-based intervention program aimed at improving daily Functioning in People Living with PCC.
Evidence of patient-reported cognitive difficulties emerging after COVID-19, operationalized as a WHODAS 2.0 Cognition Domain (D1) score > 6 at baseline via RedCAP.
Inability to undergo neuropsychological tests or additional assessments.
Prior use of the SuperCAP program.
Current participation in a trial or program aimed at improving PCC symptoms.
Any condition that, in the investigator's opinion, could make participation unsafe, complicate interpretation of study results, interfere with achievement of study objectives, or otherwise affect the participant's ability to complete the study.
Parallel
SuperCAP intervention program
DeviceThe SuperCAP (Supervised Computerized Active Program) is an online, multidimensional therapeutic program integrated into eSalut, the Catalan Institute of Health's digital platform, designed to improve daily functioning and quality of life in individuals with PCC who experience cognitive symptoms
Psychoeducational intervention
Other interventionThe psychoeducational intervention is a non-pharmacological interventions that teach practical strategies to help individuals with the cognitive disorders and fatigue associated with long COVID and provide general guidelines on how to manage these symptoms so that they have the least possible impact on daily life.
To determine whether the SuperCAP intervention program is superior to control in reducing disability.
Change in total WHODAS 2.0 score from baseline to post-intervention.
To assess whether the SuperCAP intervention leads to greater improvements in quality of life compared with control.
Change in EuroQol 5 Dimensions (EQ-5D) score from -0,654 to 1 where higher scores mean better outcome.
To assess whether the SuperCAP intervention leads to greater improvements in instrumental daily functioning compared with control.
Change in Instrumental Activities of Daily Living (IADL) score from 0 to 8 where higher score mean better outcomes.
To evaluate whether the intervention improves performance-based cognitive measures.
Change in Montreal Cognitive Assessment (MoCA) total score from 0 to 30 where higher scores mean better outcomes.
To evaluate whether the intervention improves patient-reported cognitive functioning.
Change in subjective cognitive functioning in daily life by Memory Failures of Everyday Questionnaire (MFE-30) with scores from 0 to 120 where higher scores mean worse outcomes.
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Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Lead sponsor
Fundació Institut Germans Trias i Pujol
Collaborator
