AI-assisted Migraine Education: Efficacy, Safety and Patients' Acceptance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-assisted migraine education (AIME).
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Detailed description
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.
Interventions
- Other AI-assisted migraine education (AIME)
AIME Group will undergo the established migraine education plus AI-assisted education.
Primary outcome measures
- 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. [Time frame: 3 months]
Secondary outcome measures (4)
- Investigate if the two types of educations have persistent effect over time up to 6 months. [Time frame: 6 months]
- Evaluate the participants' subjective perception of each education experience [Time frame: 6 months]
- Investigate migraine clinical course following either education interventions [Time frame: 6 months]
- Evaluate the frequency and the quality of adverse events (AEs) occurring during education interventions [Time frame: 6 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Switzerland · 1 center
- Ente Ospedaliero Cantonale - Ospedale Regionale di Lugano — Lugano
Identifiers
NCT: NCT06507150 · EOC.NSI.HA.2401