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Completed

NCT Number: NCT06315894

Supervised Computerized Active Program for 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.

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Key information

Conditions

Post-COVID Condition COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Germans Trias I Pujol Hospital

Badalona, Barcelona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SuperCAP Program

Device

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.

Primary outcomes

  1. Change in Self-reported Cognitive Functioning

    Time frame: From Baseline to Week 12

    Understanding and Communicating Scale (D1) from WHODAS 2.0 questionnaire. Scores from 0 to 20. Lower scores indicate better functioning, higher scores worse functioning.

Secondary outcomes

  1. Change in Performance-based Cognitive Functioning

    Time frame: From Baseline to Week 12

    NPZ12, global neuropsychological measure. Scores from -5 to +5. Lower scores indicate worse functioning, higher scores better functioning.

  2. Change in Depression Symptoms

    Time frame: From Baseline to Week 12

    PHQ-9 questionnaire. Scores from 0 to 27. Lower scores indicate fewer symptoms, higher scores more symptoms.

  3. Change in Anxiety Symptoms

    Time frame: From Baseline to Week 12

    GAD-7 questionnaire. Scores from 0 to 21. Lower scores indicate fewer symptoms, higher scores more symptoms.

  4. Change in Daily Activities Functioning

    Time frame: From Baseline to Week 12

    IADL scale. Scores from 0 to 20. Lower scores indicate better functioning, higher scores worse functioning.

  5. Change in Physical Activity

    Time frame: From Baseline to Week 12

    IPAQ questionnaire. Scores from 0 to undetermined (total days, hours, minutes reported). Lower scores indicate worse activity, higher scores better activity.

  6. Change in Quality of Life

    Time frame: From Baseline to Week 12

    EuroQoL-5D scale. Scores from 0 to 100. Lower scores indicate worse quality of life, higher scores better quality of life.

Sponsors and collaborators

Lead sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Other

Collaborators

  • Germans Trias i Pujol Hospital
  • Institut de Recerca de la SIDA IrsiCaixa

Registry information

Official study title

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

Acronym: SuperCAP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2024
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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