Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-26 @ 1:29 AM
Study NCT ID:
NCT06412094
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2024-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of a Mobile Health App in Managing Pediatric Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-11', 'studyFirstSubmitDate': '2024-05-05', 'studyFirstSubmitQcDate': '2024-05-11', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Oriented Eczema Measure (POEM)', 'timeFrame': 'At baseline (screening visit, Day 1) and every 3 months thereafter (visits 1 and 2).', 'description': 'A subjective tool that focuses on severity of atopic dermatitis as experienced by the patient. POEM scores can range from 0 to 28 (higher score reflects worse severity)'}, {'measure': 'SCORAD (SCORing Atopic Dermatitis)', 'timeFrame': 'At baseline (screening visit, Day 1) and every 3 months thereafter (visits 1 and 2).', 'description': 'A clinical tool for assessing the disease severity and subjective symptoms of atopic dermatitis. The SCORAD score range is between 0 and 103 points (higher score reflects worse severity).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'A randomized controlled study in children with AD, divided into three groups: a control group without access to the app, an experimental observational group with the app, and an experimental interventional group with potential investigator supervision. Outcome measures included the SCORAD and the POEM scores.', 'detailedDescription': 'Three study groups: a control group that did not use the mobile health Atopic App, an experimental observational group provided with the mobile app without supervision by the investigators and experimental interventional group provided with the mobile app with potential supervision by the investigators. Upon study enrollment, participants receive recommended treatment plans and instructions for contacting the doctor via messenger for any questions during treatment. Virtual oversight disclosed to participant of the intervention arm, including registration status and regularity of use of the app.\n\nOutcome endpoints are objective severity assessment using the SCORAD scale, and subjective assessment of effectiveness using the POEM scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '4 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with AD and their parents that provided an informed consent to participate in the study\n\nExclusion Criteria:\n\n* previous experience with the Atopic App\n* participation in affiliated online Atopic School program\n* presence of concomitant skin disease or pathological conditions that may affect the assessment of effectiveness (severe somatic diseases, mental disorders, oncologic or acute infectious diseases, etc.)\n* avoidance from registration during consecutive 5 days following the screening visit (for participants in groups 2 or 3,)'}, 'identificationModule': {'nctId': 'NCT06412094', 'briefTitle': 'Use of a Mobile Health App in Managing Pediatric Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avanta Trading Ltd.'}, 'officialTitle': 'A Comparative Controlled Study of the Effectiveness of Using a Mobile Application in Managing Pediatric Atopic Dermatitis', 'orgStudyIdInfo': {'id': '242-SSMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Standard care', 'description': 'Upon enrollment in the study at the end of the screening visit, participants in all groups receive a recommended treatment plan, according to the clinical severity of the AD, and. are instructed to contact the doctor via messenger for any questions related to their treatment.', 'interventionNames': ['Other: Standard care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care with access to the "AtopicApp" mobile application', 'description': 'Subjects in the experimental and observational groups receive access to the "AtopicApp" mobile application, in addition to receiving standard medical care.', 'interventionNames': ['Other: Standard care', 'Behavioral: Access to the "AtopicApp" mobile application']}, {'type': 'EXPERIMENTAL', 'label': 'Standard care with access to the "AtopicApp" mobile application with potential virtual oversight', 'description': "The experimental group receives standard medical care, the AtopicApp mobile application, and information about doctor's virtual oversight through the app (monitoring registration and usage).", 'interventionNames': ['Other: Standard care', 'Behavioral: Access to the "AtopicApp" mobile application', 'Behavioral: Virtual oversight through the AtopicApp']}], 'interventions': [{'name': 'Standard care', 'type': 'OTHER', 'description': 'Recommendation of standard treatment plan, according to the clinical severity of the AD, and. are instruction to contact the doctor via messenger for any questions related to treatment recommendations.', 'armGroupLabels': ['Standard care', 'Standard care with access to the "AtopicApp" mobile application', 'Standard care with access to the "AtopicApp" mobile application with potential virtual oversight']}, {'name': 'Access to the "AtopicApp" mobile application', 'type': 'BEHAVIORAL', 'description': 'Access to the "AtopicApp" mobile application with 1 day after enrollment.', 'armGroupLabels': ['Standard care with access to the "AtopicApp" mobile application', 'Standard care with access to the "AtopicApp" mobile application with potential virtual oversight']}, {'name': 'Virtual oversight through the AtopicApp', 'type': 'BEHAVIORAL', 'description': "Notification of doctor's virtual oversight through the AtopicApp mobile application.", 'armGroupLabels': ['Standard care with access to the "AtopicApp" mobile application with potential virtual oversight']}]}, 'contactsLocationsModule': {'locations': [{'zip': '443079', 'city': 'Samara', 'country': 'Russia', 'facility': 'Samara State Medical University', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}], 'overallOfficials': [{'name': 'Natalia Migacheva, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samara State Medical University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'March 2024', 'ipdSharing': 'YES', 'description': 'De-identified IPD will be available to qualified researchers upon request by email to the principal investigator.', 'accessCriteria': 'Upon request from an interested researcher'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avanta Trading Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}