Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT06315894
Status:
RECRUITING
Last Update Posted:
2024-11-14
First Post:
2024-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supervised Computerized Active Program for People With Post-COVID Syndrome (SuperCAP Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-03-15', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Self-reported Cognitive Functioning', 'timeFrame': 'From Baseline to Week 12', 'description': 'Understanding and Communicating Scale (D1) from WHODAS 2.0 questionnaire. Scores from 0 to 20. Lower scores indicate better functioning, higher scores worse functioning.'}], 'secondaryOutcomes': [{'measure': 'Change in Performance-based Cognitive Functioning', 'timeFrame': 'From Baseline to Week 12', 'description': 'NPZ12, global neuropsychological measure. Scores from -5 to +5. Lower scores indicate worse functioning, higher scores better functioning.'}, {'measure': 'Change in Depression Symptoms', 'timeFrame': 'From Baseline to Week 12', 'description': 'PHQ-9 questionnaire. Scores from 0 to 27. Lower scores indicate fewer symptoms, higher scores more symptoms.'}, {'measure': 'Change in Anxiety Symptoms', 'timeFrame': 'From Baseline to Week 12', 'description': 'GAD-7 questionnaire. Scores from 0 to 21. Lower scores indicate fewer symptoms, higher scores more symptoms.'}, {'measure': 'Change in Daily Activities Functioning', 'timeFrame': 'From Baseline to Week 12', 'description': 'IADL scale. Scores from 0 to 20. Lower scores indicate better functioning, higher scores worse functioning.'}, {'measure': 'Change in Physical Activity', 'timeFrame': 'From Baseline to Week 12', 'description': 'IPAQ questionnaire. Scores from 0 to undetermined (total days, hours, minutes reported). Lower scores indicate worse activity, higher scores better activity.'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'From Baseline to Week 12', 'description': 'EuroQoL-5D scale. Scores from 0 to 100. Lower scores indicate worse quality of life, higher scores better quality of life.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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)'], 'conditions': ['Post-COVID Condition']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'SuperCAP study will include 2 stages.\n\nStage 1 will involve the composition of a focus group previous to the effectiveness study development.\n\nThe 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.\n\nStage 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.\n\nTwo study groups will participate: the Intervention Group and the Control Group.\n\nThe Intervention Group will be comprised by people with post-COVID condition who will follow the intervention program proposed.\n\nThe Control Group will be comprised by people with post-COVID condition who will not follow the program.\n\nBoth groups will fulfill the same study participation criteria.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presenting Post-COVID Syndrome, defined as presenting 3 or more symptoms associated with post-COVID condition for at least 3 months.\n* Age of 18-65 years old.\n* Presence of self-reported cognitive complaints associated with post-COVID infection.\n* Positive and favorable attitude on the use of electronic devices.\n* Will to participate in a stimulation program for improvement of cognitive symptoms.\n* Availability of cell phone and computer or tablet with the minimum technical features considered.\n\nExclusion Criteria:\n\n* Inability to undergo the neuropsychological tests or complementary study assessments.\n* Current participation in a trial or program for improvement of post-COVID symptoms.\n* 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."}, 'identificationModule': {'nctId': 'NCT06315894', 'acronym': 'SuperCAP', 'briefTitle': 'Supervised Computerized Active Program for People With Post-COVID Syndrome (SuperCAP Study)', 'organization': {'class': 'OTHER', 'fullName': 'Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PI-22-191'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'People with post-COVID syndrome following the intervention', 'interventionNames': ['Device: SuperCAP Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'People with post-COVID syndrome not following the intervention'}], 'interventions': [{'name': 'SuperCAP Program', 'type': 'DEVICE', 'description': 'Distance program including tasks and exercises to improve cognitive, emotional, and functional status.\n\nThe intervention will be applied via cell phone and will have a duration of 3 months (12 weeks).\n\nTasks and exercises will be performed 5 days per week. Contents of the program will include daily exercises, daily games, daily videos, and weekly videos.\n\nThey will address cognitive functions, daily habits, and lifestyle factors in general.\n\nCompliance will be monitored to control the adherence to the intervention. The program has been designed specifically for people with post-COVID syndrome.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose A MUñoz-Moreno, MD,PhD', 'role': 'CONTACT', 'email': 'jmuñoz@lluita.org', 'phone': '93 465 7897'}, {'name': 'Jose A. Muñoz-Moreno, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Germans Trias I Pujol Hospital', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}], 'centralContacts': [{'name': 'Jose A. Muñoz Moreno, MD,PhD', 'role': 'CONTACT', 'email': 'jmuñoz@lluita.org', 'phone': '93 4657897'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut de Recerca de la SIDA IrsiCaixa', 'class': 'UNKNOWN'}, {'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}