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| Name | Class |
|---|---|
| Institut de Recerca de la SIDA IrsiCaixa | UNKNOWN |
| Germans Trias i Pujol Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | People with post-COVID syndrome following the intervention |
|
| Control | No Intervention | People with post-COVID syndrome not following the intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Germans Trias I Pujol Hospital | Badalona | Barcelona | 08916 | Spain |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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Randomized Controlled Trial
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|
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 |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |