AI-assisted Migraine Education: Efficacy, Safety and Patients' Acceptance
ConditionMigraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEnte Ospedaliero Cantonale, Bellinzona
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged between 18 and 65 years at the time of signing the informed consent
Newly diagnosis of migraine, confirmed through the medical chart
The participant must be capable of giving signed informed consent
Access to a laptop, computer, smartphone, or tablet
Disqualifiers
Insufficient knowledge of the protocol language (italian)
Patients with cognitive impairment and/or unable to use or access the AI-powered learning platform developed in this study.
Vulnerable participants (e.g. minors, participants incapable of judgment or participants under tutelage)
Trial design
Design model
Parallel
Treatments tested in this trial
AI-assisted migraine education (AIME)
Other interventionAIME Group will undergo the established migraine education plus AI-assisted education.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: AIME - AI-assisted migraine educationExperimental treatment 1 intervention
Group B: SME -Standard Migraine EducationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
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.
Time frame
3 monthsSecondary outcomes
1
Investigate if the two types of educations have persistent effect over time up to 6 months.
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.
Time frame
6 months2
Evaluate the participants' subjective perception of each education experience
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
Time frame
6 months3
Investigate migraine clinical course following either education interventions
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.
Time frame
6 months4
Evaluate the frequency and the quality of adverse events (AEs) occurring during education interventions
To describe frequency and type of AEs occurring during the study period in SME and AIME groups.education interventions
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov