Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:31 PM
Study NCT ID:
NCT07448233
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-04
First Post:
2025-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of an AI-Based Health Management System in Long-Term Epilepsy Management in Rural Areas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-12-15', 'size': 121801, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-02-27T01:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2025-12-21', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seizure change', 'timeFrame': '12 months', 'description': 'Evaluation method: Calculate by comparing the frequency of attacks during the baseline period (12 months before enrollment) with the monthly average frequency of attacks during the intervention period (12 months)'}, {'measure': 'Epilepsy Self Management Scale Score', 'timeFrame': '12 months', 'description': 'Evaluation method: The Chinese version of the Epilepsy Self Management Scale was used. This scale includes multiple dimensions (such as drug management, information management, safety management, etc.), and a higher total score indicates stronger self-management ability.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsies', 'Remote Management of Epilepsy in Rural Areas']}, 'descriptionModule': {'briefSummary': 'This project, titled "Application of an AI-Based Health Management System in Long-Term Epilepsy Management in Rural Areas ", is led by the First Affiliated Hospital of Air Force Medical University, with Jiang Wen as the principal investigator. It is a prospective, multicenter, cluster-randomized controlled trial involving 756 patients from eight rural counties in China\'s northwest region. The study aims to evaluate the effectiveness of an AI-assisted remote healthcare system (via a WeChat mini-program) compared to standard care in reducing seizure frequency and improving self-management skills among adult epilepsy patients. Key components include patient and doctor interfaces for features like AI consultations, medication reminders, and online consultations. The trial runs from December 1, 2025, to November 30, 2027, with primary outcomes measured at 12 months and secondary outcomes assessing medication adherence, quality of life, and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets ILAE 2017 diagnostic criteria for epilepsy.\n* ≥1 bilateral tonic-clonic seizure in the past 12 months.\n* Aged 18-65 years.\n* Access to a smartphone patient/caregiver.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Pregnancy, lactation, or planned pregnancy.\n* Seizures with identifiable triggers e.g., alcohol withdrawal.\n* Allergy to phenobarbital/sodium valproate.\n* Severe comorbidities e.g., organ dysfunction, malignancy, psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT07448233', 'briefTitle': 'Application of an AI-Based Health Management System in Long-Term Epilepsy Management in Rural Areas', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Application of an AI-Based Health Management System in Long-Term Epilepsy Management in Rural Areas', 'orgStudyIdInfo': {'id': 'XJLL-KY-20252555'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Rural Epilepsy Management'}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced Management with Mobile App', 'interventionNames': ['Device: AI-enabled WeChat mini-program "Epilepsy Smart Monitoring and Diagnosis System":']}], 'interventions': [{'name': 'AI-enabled WeChat mini-program "Epilepsy Smart Monitoring and Diagnosis System":', 'type': 'DEVICE', 'description': 'Patient Module: Real-time monitoring, medication reminders, AI consultations, seizure logging, educational resources.\n\nPhysician Module: AI-assisted diagnostics, online consultations, data analytics dashboard.', 'armGroupLabels': ['Enhanced Management with Mobile App']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Department of Neurology, Xijing Hospital, Air Force Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared due to privacy constraints, contractual agreements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}