Post COVID Condition
Conditions
Keywords
Post COVID Condition, Long COVID, SuperCAP
Brief summary
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.
Detailed description
-COVID-19 Condition (PCC) is a major public health challenge, with cognitive impairment and fatigue among its most prevalent and disabling symptoms, leading to substantial limitations in quality of life and daily functioning. Digital health solutions provide an opportunity to expand access to structured, evidence-informed care. SuperCAP was developed as a multidisciplinary digital therapeutic program to support cognitive and functional recovery in individuals with PCC. A randomized pilot study demonstrated its feasibility and acceptability, supporting the conduct of a larger randomized controlled trial to evaluate its efficacy on disability and cognitive outcomes. Participants will be randomized (1:1) to receive the digital intervention (SuperCAP) or Standard of Care (SoC) during 13 weeks, followed by a 12-week observation period. The primary objective is to determine whether the SuperCAP intervention program is superior to control in reducing disability from baseline to the post-intervention assessment. The secondary objectives include evaluating the effects of SuperCAP on quality of life, daily functioning, cognitive and emotional outcomes, the durability of these effects at follow-up, and the feasibility and acceptability of program implementation.
Interventions
DEVICESuperCAP intervention program
The 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
OTHERPsychoeducational intervention
The 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.
Sponsors
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Fundació Institut Germans Trias i Pujol
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Digital proficiency defined as scoring ≥4 on MDPQ-16 item 2a (sending emails) and ≥3 on item 6a (using the device's app store) via RedCAP. * Self-reported ability to use a mobile application for approximately 15 minutes per day, 5 days per week, considering their current symptoms. * Possession of a personal smartphone compatible with the study mobile application (eSalut), with sufficient storage space and operating system version required for installation.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine whether the SuperCAP intervention program is superior to control in reducing disability. | From baseline (week 0) to the post-intervention assessment (week 13). | Change in total WHODAS 2.0 score from baseline to post-intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess whether the SuperCAP intervention leads to greater improvements in quality of life compared with control. | From baseline (week 0) to post-intervention (week 13) | 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. | From baseline (week 0) to post-intervention (week 13). | 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. | From baseline (week 0) to post-intervention (week 13). | 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. | From baseline (week 0) to post-intervention (week 13). | 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. |
| To assess reductions in depressive symptoms following the intervention. | From baseline (week 0) to post-intervention (week 13) | Change in Patient Health Questionnaire-9 (PHQ-9) with scores from 0 to 27 where higher scores means worse outcomes. |
| To assess reductions in anxiety symptoms following the intervention. | From baseline (week 0) to post-intervention (week 13). | Change in Generalized Anxiety Disorder-7 (GAD-7) score from 0 to 21 where higher scores mean worse outcomes. |
| To determine whether improvements in functional outcomes are sustained at follow-up. | From post-intervention (week 13) to follow-up (week 25). | Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) score from 0 to 144 where higher scores mean worse outcomes. |
| To determine whether improvements in cognitive outcomes are sustained at follow-up. | From post-intervention (week 13) to follow-up (week 25). | Change in Montreal Cognitive Assessment (MoCA) score from 0 to 30 where higher scores mean better outcomes. |
| To determine whether improvements in emotional outcomes are sustained at follow-up. | From post-intervention (week 13) to follow-up (week 25). | Change in EuroQol 5 Dimensions (EQ-5D) score from -0,654 to 1 where higher scores mean better outcomes. |
| To evaluate feasibility of implementation, including adherence to the program. | From post-intervention (week 13) to follow-up (week 25) | Program adherence captured through platform telemetry. |
| To evaluate feasibility of implementation, including usability. | From post-intervention (week 13) to follow-up (week 25) | Usability measured by System Usability Score (SUS) score from 0 to 100 where higher scores mean better outcomes. |
| To evaluate feasibility of implementation, including satisfaction and retention. | From post-intervention (week 13) to follow-up (week 25). | Participant satisfaction and perceived benefit will be assessed through a brief set of items evaluating overall satisfaction with the program, perceived usefulness and perceived improvement in daily functioning. |
| To explore indicators of acceptability. | From post-intervention (week 13) to follow-up (week 25). | Acceptability assessed using the Acceptability of Intervention Measure (AIM) scale which goes from 1 to 5 and higher scores mean better outcomes. |
| To explore indicators of appropriateness. | From post-intervention (week 13) to follow-up (week 25). | Appropriateness assessed using Intervention Appropriateness Measure (IAM) scale which goes from 1 to 5 where higher scores mean better outcomes. |
| To explore indicators of implementation. | From post-intervention (week 13) to follow-up (week 25). | Feasibility assessed using the Feasibility of Intervention Measure (FIM) scale which goes from 1 to 5 and higher scores mean better outcomes. |
| To explore preliminary economic feasibility indicators. | From post-intervention (week 13) to follow-up (week 25). | Economic feasibility will be explored through resource-use variables professional time required for support or monitoring, number and type of user support contacts or technical incidents requiring intervention). |
Countries
Spain
Contacts
CONTACTAnna Prats, PhD
CONTACTDavid Rovira
PRINCIPAL_INVESTIGATORAnna Prats, PhD
Fundació Lluita contra les Infeccions
Outcome results
None listed