Actively Recruiting
AI-assisted Migraine Education: Efficacy, Safety and Patients' Acceptance
Led by Ente Ospedaliero Cantonale, Bellinzona · Updated on 2026-03-12
140
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Migraine affects about one in seven people worldwide and significantly reduces quality of life and work productivity. Many patients face challenges like misdiagnosis, poor treatment, and stigma due to limited understanding of the condition. This research investigates whether adding AI-assisted migraine education to standard education can better improve patients' knowledge about their migraine. Participants are randomly assigned to one of two groups: one receives standard migraine education, and the other receives both standard education plus AI-assisted migraine education. The AI component uses adaptive learning technologies to provide personalized content that matches each patient's knowledge and learning pace. This approach aims to enhance understanding and engagement with migraine management. During the study, participants' understanding of migraine will be assessed over three months, with follow-up evaluations up to six months. Researchers will also collect data on participants' views of the education, migraine symptoms over time, and any adverse events related to the education programs. The study requires participants to have access to a digital device and the ability to provide informed consent. The total study duration includes education and follow-up assessments.
CONDITIONS
Brief Title
AI-assisted Migraine Education: Efficacy, Safety and Patients' Acceptance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 65 years at the time of signing the informed consent
- Newly diagnosed with migraine confirmed through medical chart
- Capable of giving signed informed consent
- Access to a laptop, computer, smartphone, or tablet
You will not qualify if you...
- Insufficient knowledge of the protocol language (Italian)
- Cognitive impairment or unable to use/access the AI learning platform
- Vulnerable participants such as minors, those incapable of judgment, or under tutelage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive either AI-assisted migraine education plus standard education or standard migraine education alone to improve understanding of their condition.
Participants access educational content remotely at their own pace; study assessments occur at baseline and 3 months.
Duration - 3 additional months (up to 6 months total)
Participants are monitored to assess the persistent effects of the education interventions, their perception, migraine clinical course, and any adverse events.
Follow-up assessments at 6 months after enrollment
Trial Site Locations
Total: 1 location
1
Ente Ospedaliero Cantonale - Ospedale Regionale di Lugano
Lugano, Switzerland
Actively Recruiting
Research Team
G
Giulia Mallucci, Prof. Dr.ssa med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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