SuperCAP Program to Improve Cognition and Daily Functioning in Post-COVID-19 Condition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SuperCAP intervention program, Psychoeducational intervention.
- Who it may be relevant to
- Registry conditions: Post COVID Condition. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Controlled Trial to Assess the Efficacy of a Supervised Computerized Active Program (SuperCAP) to Improve Cognition and Daily Functioning in People With Post-COVID-19 Condition
Overview
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
- Device SuperCAP 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 - Other Psychoeducational 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.
Primary outcome measures
- To determine whether the SuperCAP intervention program is superior to control in reducing disability. [Time frame: From baseline (week 0) to the post-intervention assessment (week 13).]
Secondary outcome measures (12)
- To assess whether the SuperCAP intervention leads to greater improvements in quality of life compared with control. [Time frame: From baseline (week 0) to post-intervention (week 13)]
- To assess whether the SuperCAP intervention leads to greater improvements in instrumental daily functioning compared with control. [Time frame: From baseline (week 0) to post-intervention (week 13).]
- To evaluate whether the intervention improves performance-based cognitive measures. [Time frame: From baseline (week 0) to post-intervention (week 13).]
- To evaluate whether the intervention improves patient-reported cognitive functioning. [Time frame: From baseline (week 0) to post-intervention (week 13).]
- To assess reductions in depressive symptoms following the intervention. [Time frame: From baseline (week 0) to post-intervention (week 13)]
- To assess reductions in anxiety symptoms following the intervention. [Time frame: From baseline (week 0) to post-intervention (week 13).]
- To determine whether improvements in functional outcomes are sustained at follow-up. [Time frame: From post-intervention (week 13) to follow-up (week 25).]
- To determine whether improvements in cognitive outcomes are sustained at follow-up. [Time frame: From post-intervention (week 13) to follow-up (week 25).]
- To determine whether improvements in emotional outcomes are sustained at follow-up. [Time frame: From post-intervention (week 13) to follow-up (week 25).]
- To evaluate feasibility of implementation, including adherence to the program. [Time frame: From post-intervention (week 13) to follow-up (week 25)]
- To evaluate feasibility of implementation, including usability. [Time frame: From post-intervention (week 13) to follow-up (week 25)]
- To evaluate feasibility of implementation, including satisfaction and retention. [Time frame: From post-intervention (week 13) to follow-up (week 25).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Fundació Lluita contra les Infeccions - Hospital Universitari Germans Trias i Pujol — Badalona
Identifiers
NCT: NCT07530757 · SuperCAP Trial