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

NCT ID: NCT06507150

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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AIME - AI-assisted migraine education

Intervention group: it receives AI-assisted migraine education in addition to standard migraine education

Group Type EXPERIMENTAL

AI-assisted migraine education (AIME)

Intervention Type OTHER

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

SME -Standard Migraine Education

Control group: it receives standard migraine education only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AI-assisted migraine education (AIME)

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ente Ospedaliero Cantonale, Bellinzona

OTHER

Sponsor Role lead

Responsible Party

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Chiara Zecca

Prof, dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ente Ospedaliero Cantonale - Ospedale Regionale di Lugano

Lugano, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Giulia Mallucci, Prof. Dr.ssa med.

Role: CONTACT

+41 91 811 69 21

Facility Contacts

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Mallucci

Role: primary

+41 91 811 69 21

Other Identifiers

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EOC.NSI.HA.2401

Identifier Type: -

Identifier Source: org_study_id

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