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

F

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

Status

Completed

Conditions

Post-COVID Condition

Treatments

Device: SuperCAP Program

Study type

Interventional

Funder types

Other

Identifiers

NCT06315894
PI-22-191

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Experimental
Experimental group
Description:
People with post-COVID syndrome following the intervention
Treatment:
Device: SuperCAP Program
Control
No Intervention group
Description:
People with post-COVID syndrome not following the intervention

Trial contacts and locations

1

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Central trial contact

Jose A. Muñoz Moreno, MD,PhD

Data sourced from clinicaltrials.gov

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