Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-02-25 @ 2:41 AM
Study NCT ID:
NCT06507150
Status:
RECRUITING
Last Update Posted:
2025-02-27
First Post:
2024-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI-assisted Migraine Education: Efficacy, Safety and Patients' Acceptance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2024-07-04', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The primary objective of this study is to ascertain if the addition of AI-assisted migraine education to standard migraine education yields a superior improvement in the patients' understanding of their condition.", 'timeFrame': '3 months', 'description': 'Difference in the proportion of correct responses to a set of 20 migraine-related questions via the Migraine Intel Quotient test score (MiQ score) between Standard Migraine Education (SME Group) and the AI-assisted migraine education added to Standard Migraine Education (AIME group) at 3 months after baseline.'}], 'secondaryOutcomes': [{'measure': 'Investigate if the two types of educations have persistent effect over time up to 6 months.', 'timeFrame': '6 months', 'description': 'To assess changes in the MiQ score from baseline to 3 months and to 6 months, and from 3 months to 6 months in the SME group and AIME group.'}, {'measure': "Evaluate the participants' subjective perception of each education experience", 'timeFrame': '6 months', 'description': "To report patients' evaluation of learning experience at 3 and 6 months after baseline in both SME and AIME groups by 10 Visual Analog Scale (VAS) scoring, and comparison between groups at each timepoint"}, {'measure': 'Investigate migraine clinical course following either education interventions', 'timeFrame': '6 months', 'description': 'To assess changes in the number of monthly migraine days, migraine intensity, and migraine duration as well as the HIT-6 and MIDAS scores at 3 and 6 months after baseline in SME and AIME groups, and between SME and AIME groups at each time point.'}, {'measure': 'Evaluate the frequency and the quality of adverse events (AEs) occurring during education interventions', 'timeFrame': '6 months', 'description': 'To describe frequency and type of AEs occurring during the study period in SME and AIME groups.education interventions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': "Migraine affects 1 in 7 people globally, significantly impacting quality of life and economic productivity. Despite its prevalence, limited awareness leads to misdiagnosis, inadequate treatment, and stigmatization. AI can enhance migraine management through improved diagnosis, prediction, and personalized education. The primary objective of this study is to determine if adding AI-assisted migraine education to standard education improves patients' understanding of their condition more effectively.", 'detailedDescription': "Migraine affecting approximately 1 in 7 individuals globally, significantly impacts quality of life and economic productivity due to its associated healthcare and social burdens. Despite its prevalence, awareness and understanding of migraine remain limited, contributing to misdiagnosis, inadequate treatment, and the perpetuation of stigmatization.\n\nArtificial Intelligence (AI) may advance migraine management by improving diagnosis, prediction, and educational outreach. AI applications are currently being employed in diagnosing migraines more accurately by analyzing comprehensive patient data, thus differentiating migraine from other types of headaches. Additionally, AI algorithms predict migraine episodes, enabling preemptive measures. They also streamline medication management through reminders and monitor patient adherence, which is crucial for preventing medication overuse and optimizing treatment outcomes.\n\nMoreover, AI can bridge the educational gap in migraine understanding. By using adaptive learning technologies, AI platforms can deliver personalized educational content, tailored to an individual's knowledge level and learning pace, enhancing understanding and engagement. This approach not only facilitates better management of the condition but also promotes a broader societal awareness essential for destigmatizing migraine.\n\nThe primary objective of this study is to ascertain if the addition of AI-assisted migraine education to standard migraine education yields a superior improvement in the patients' understanding of their condition."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 18 and 65 years at the time of signing the informed consent\n* Newly diagnosis of migraine, confirmed through the medical chart\n* The participant must be capable of giving signed informed consent\n* Access to a laptop, computer, smartphone, or tablet\n\nExclusion Criteria:\n\n* Insufficient knowledge of the protocol language (italian)\n* Patients with cognitive impairment and/or unable to use or access the AI-powered learning platform developed in this study.\n* Vulnerable participants (e.g. minors, participants incapable of judgment or participants under tutelage)'}, 'identificationModule': {'nctId': 'NCT06507150', 'briefTitle': "AI-assisted Migraine Education: Efficacy, Safety and Patients' Acceptance", 'organization': {'class': 'OTHER', 'fullName': 'Ente Ospedaliero Cantonale, Bellinzona'}, 'officialTitle': "AI-assisted Migraine Education: Efficacy, Safety and Patients' Acceptance", 'orgStudyIdInfo': {'id': 'EOC.NSI.HA.2401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AIME - AI-assisted migraine education', 'description': 'Intervention group: it receives AI-assisted migraine education in addition to standard migraine education', 'interventionNames': ['Other: AI-assisted migraine education (AIME)']}, {'type': 'NO_INTERVENTION', 'label': 'SME -Standard Migraine Education', 'description': 'Control group: it receives standard migraine education only'}], 'interventions': [{'name': 'AI-assisted migraine education (AIME)', 'type': 'OTHER', 'description': 'AIME Group will undergo the established migraine education plus AI-assisted education.', 'armGroupLabels': ['AIME - AI-assisted migraine education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lugano', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Mallucci', 'role': 'CONTACT', 'email': 'giulia.mallucci@eoc.ch', 'phone': '+41 91 811 69 21'}], 'facility': 'Ente Ospedaliero Cantonale - Ospedale Regionale di Lugano', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}], 'centralContacts': [{'name': 'Giulia Mallucci, Prof. Dr.ssa med.', 'role': 'CONTACT', 'email': 'giulia.mallucci@eoc.ch', 'phone': '+41 91 811 69 21'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ente Ospedaliero Cantonale, Bellinzona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof, dr', 'investigatorFullName': 'Chiara Zecca', 'investigatorAffiliation': 'Ente Ospedaliero Cantonale, Bellinzona'}}}}