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临床试验/NCT06507150
NCT06507150招募中不适用

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

Ente Ospedaliero Cantonale, Bellinzona1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
140
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

AIME - AI-assisted migraine education

Experimental

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

干预措施: AI-assisted migraine education (AIME) (Other)

SME -Standard Migraine Education

No Intervention

Control group: it receives standard migraine education only

结局指标

主要结局

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.

时间窗: 3 months

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.

次要结局

  • Investigate migraine clinical course following either education interventions(6 months)
  • Investigate if the two types of educations have persistent effect over time up to 6 months.(6 months)
  • Evaluate the frequency and the quality of adverse events (AEs) occurring during education interventions(6 months)
  • Evaluate the participants' subjective perception of each education experience(6 months)

研究者

发起方
Ente Ospedaliero Cantonale, Bellinzona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chiara Zecca

Prof, dr

Ente Ospedaliero Cantonale, Bellinzona

研究点 (1)

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