Clinical trial NCT06315894: Supervised Computerized Active Program for People With Post-COVID Syndrome (SuperCAP Study)
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-COVID Condition
Keywords: Long COVID (LC)
Post-Acute COVID-19 Syndrome (PACS)
Post-Acute Sequelae of COVID-19 (PASC)
Post-Acute Sequelae of SARS-CoV-2 (PASS)
Post-COVID Condition (PCC)
Post-COVID Syndrome (PCS)
Lead sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Sponsor class: OTHER
Collaborators: name: Institut de Recerca de la SIDA IrsiCaixa
name: Germans Trias i Pujol Hospital
First posted: 2024-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Self-reported Cognitive Functioning
timeFrame: From Baseline to Week 12
Secondary outcomes:
measure: Change in Performance-based Cognitive Functioning
timeFrame: From Baseline to Week 12
measure: Change in Depression Symptoms
timeFrame: From Baseline to Week 12
measure: Change in Anxiety Symptoms
timeFrame: From Baseline to Week 12
measure: Change in Daily Activities Functioning
timeFrame: From Baseline to Week 12
measure: Change in Physical Activity
timeFrame: From Baseline to Week 12
measure: Change in Quality of Life
timeFrame: From Baseline to Week 12
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Germans Trias I Pujol Hospital
state: Barcelona
Study officials:
References: