Supervised Computerized Active Program for People With Post-COVID Syndrome (SuperCAP Study)
- Conditions
- Post-COVID Condition
- Interventions
- Device: SuperCAP Program
- Registration Number
- NCT06315894
- Lead Sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental SuperCAP Program People with post-COVID syndrome following the intervention
- Primary Outcome Measures
Name Time Method Change in Self-reported Cognitive Functioning 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 Outcome Measures
Name Time Method Change in Physical Activity 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.
Change in Depression Symptoms From Baseline to Week 12 PHQ-9 questionnaire. Scores from 0 to 27. Lower scores indicate fewer symptoms, higher scores more symptoms.
Change in Anxiety Symptoms From Baseline to Week 12 GAD-7 questionnaire. Scores from 0 to 21. Lower scores indicate fewer symptoms, higher scores more symptoms.
Change in Daily Activities Functioning From Baseline to Week 12 IADL scale. Scores from 0 to 20. Lower scores indicate better functioning, higher scores worse functioning.
Change in Performance-based Cognitive Functioning From Baseline to Week 12 NPZ12, global neuropsychological measure. Scores from -5 to +5. Lower scores indicate worse functioning, higher scores better functioning.
Change in Quality of Life 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.
Trial Locations
- Locations (1)
Germans Trias I Pujol Hospital
🇪🇸Badalona, Barcelona, Spain