AI-Based Mobile Intervention on Medication Non-Adherence and Transition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Examine the effect of Medilepsy® with and without responsible AI design on medication adherence.
研究概览
简要总结
This study aims to examine whether the AI-personalized version of the Medilepsy® app is more effective than the non-AI (standard version without AI personalization) can improve key outcomes, such as medical adherence and transition readiness, among underserved adolescents and young adults with epilepsy, ages 14-24, in Florida, USA.
Outcomes are organized into primary (effectiveness), secondary (usability), and exploratory (language experience) endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with epilepsy
- •Currently prescribed anti-seizure medicine (ASMs)
- •Identified as part of an underserved population, defined as meeting at least one of the following: member of a racial or ethnic group historically underrepresented in research or healthcare or low-income status (e.g., eligible for public assistance or government-subsidized health coverage)
- •Are between 14-17 years old and able to provide assent, with a parent or LAR present to receive app notifications throughout the study
- •Are between 18-24 years old and able to provide informed consent
- •Able to read, speak, and write in English
- •Resides in Florida
- •Receive outpatient medical services
排除标准
- •They do not own a mobile device with internet access.
- •They have a history of severe intellectual disability.
- •They are unable to operate a mobile device (keyboard or touchscreen).
- •Reside in an in-patient setting.
- •Adults unable to consent.
- •Pregnant women (excluded because pregnancy is not relevant to the study focus).
- •Prisoners.
研究组 & 干预措施
Medilepsy® Chatbot AI-Enhanced
Participants in the intervention group will use the AI-personalized version of the Medilepsy® app.
干预措施: Medilepsy® Chatbot AI-Enhanced (Other)
Medilepsy® Chatbot Standard
Participants in the non-intervention group will use a standard version of the Medilepsy® app without AI functionality.
干预措施: Medilepsy® Chatbot Standard (Other)
结局指标
主要结局
Examine the effect of Medilepsy® with and without responsible AI design on medication adherence.
时间窗: 3-6 months
Participants will demonstrate significant improvement in medication adherence measured by Medication adherence rate (MAR) formula: The average number of missed medications. Adherence Rate (%) = (Number of prescribed ASM doses taken / Number of prescribed ASM doses scheduled) × 100.
次要结局
- Examine the effect of Medilepsy® with and without responsible AI design on transition readiness skills.(3-6 months)
- Evaluate the usability of Medilepsy® at study completion.(3-6 months)