Supervised Computerized Active Program for People With Post-COVID Syndrome (SuperCAP Study) (SuperCAP)

Design and Implementation of a Supervised Computerized Active Program (SuperCAP) for Improvement of Cognitive, Emotional, and Functional Status in People With Post-COVID Syndrome. SuperCAP Study

SuperCAP study is a project aimed at designing and implementing an online program for improvement of cognitive, emotional, and functional status in post-COVID condition.

Study Overview

• Status: Completed
• Conditions: Post-COVID Condition
• Intervention / Treatment: Device: SuperCAP Program

Detailed Description

SuperCAP study will include 2 stages.

Stage 1 will involve the composition of a focus group previous to the effectiveness study development.

The work with this focus group will have several aims, among them, mainly, to participate in the design of the intervention program, and to provide feedback on the study follow-up.

Stage 2 will include the effectiveness study. This stage will comprise the initiation of the intervention program, study follow-up, and dissemination of the results in the end of the project.

Two study groups will participate: the Intervention Group and the Control Group.

The Intervention Group will be comprised by people with post-COVID condition who will follow the intervention program proposed.

The Control Group will be comprised by people with post-COVID condition who will not follow the program.

Both groups will fulfill the same study participation criteria.

The intervention will consist of the follow-up of a distance program via mobile/tablet. This program will integrate different games and exercises always with the objective of stimulating the cognitive functioning and the emotional status.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Germans Trias i Pujol Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Presenting Post-COVID Syndrome, defined as presenting 3 or more symptoms associated with post-COVID condition for at least 3 months.
• Age of 18-65 years old.
• Presence of self-reported cognitive complaints associated with post-COVID infection.
• Positive and favorable attitude on the use of electronic devices.
• Will to participate in a stimulation program for improvement of cognitive symptoms.
• Availability of cell phone and computer or tablet with the minimum technical features considered.

Exclusion Criteria:

• Inability to undergo the neuropsychological tests or complementary study assessments.
• Current participation in a trial or program for improvement of post-COVID symptoms.
• Any condition that in the opinion of the investigator would make study participation unsafe, complicate interpretation of study outcome data, interfere with achieving the study objectives, or otherwise could impair the subject's ability to complete the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; People with post-COVID syndrome following the intervention	Device: SuperCAP Program; Distance program including tasks and exercises to improve cognitive, emotional, and functional status. The intervention will be applied via cell phone and will have a duration of 3 months (12 weeks). Tasks and exercises will be performed 5 days per week. Contents of the program will include daily exercises, daily games, daily videos, and weekly videos. They will address cognitive functions, daily habits, and lifestyle factors in general. Compliance will be monitored to control the adherence to the intervention. The program has been designed specifically for people with post-COVID syndrome.
No Intervention: Control; People with post-COVID syndrome not following the intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-reported Cognitive Functioning	Understanding and Communicating Scale (D1) from WHODAS 2.0 questionnaire. Scores from 0 to 20. Lower scores indicate better functioning, higher scores worse functioning.	From Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Performance-based Cognitive Functioning	NPZ12, global neuropsychological measure. Scores from -5 to +5. Lower scores indicate worse functioning, higher scores better functioning.	From Baseline to Week 12
Change in Depression Symptoms	PHQ-9 questionnaire. Scores from 0 to 27. Lower scores indicate fewer symptoms, higher scores more symptoms.	From Baseline to Week 12
Change in Anxiety Symptoms	GAD-7 questionnaire. Scores from 0 to 21. Lower scores indicate fewer symptoms, higher scores more symptoms.	From Baseline to Week 12
Change in Daily Activities Functioning	IADL scale. Scores from 0 to 20. Lower scores indicate better functioning, higher scores worse functioning.	From Baseline to Week 12
Change in Physical Activity	IPAQ questionnaire. Scores from 0 to undetermined (total days, hours, minutes reported). Lower scores indicate worse activity, higher scores better activity.	From Baseline to Week 12
Change in Quality of Life	EuroQoL-5D scale. Scores from 0 to 100. Lower scores indicate worse quality of life, higher scores better quality of life.	From Baseline to Week 12

Collaborators and Investigators

• Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Collaborators: Germans Trias i Pujol Hospital; Institut de Recerca de la SIDA IrsiCaixa

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): September 5, 2024
• Study Completion (Actual): September 5, 2024

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Post-Acute Sequelae of COVID-19 (PASC); Post-Acute COVID-19 Syndrome (PACS); Long COVID (LC); Post-Acute Sequelae of SARS-CoV-2 (PASS); Post-COVID Condition (PCC); Post-COVID Syndrome (PCS)
• Additional Relevant MeSH Terms: Post-Infectious Disorders; COVID-19; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: PI-22-191

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No