AI-assisted Migraine Education: Efficacy, Safety and Patients' Acceptance

Ente Ospedaliero Cantonale, Bellinzona140 enrolled

Overview

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.

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. Artificial 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. Moreover, 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. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

Conditions

Migraine

Interventions

AI-assisted migraine education (AIME)OTHER

AIME Group will undergo the established migraine education plus AI-assisted education.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Locations (1)

Ente Ospedaliero Cantonale - Ospedale Regionale di Lugano

Lugano, Switzerland

RECRUITING

Outcomes

Primary Outcomes

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 months

Secondary Outcomes

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 months

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 months

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 months

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 months

Central Contacts

Giulia Mallucci, Prof. Dr.ssa med.

CONTACT

+41 91 811 69 21 giulia.mallucci@eoc.ch

Data from ClinicalTrials.gov

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