Application of an AI-Based Health Management System in Long-Term Epilepsy Management in Rural Areas
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Seizure change
研究概览
简要总结
This project, titled "Application of an AI-Based Health Management System in Long-Term Epilepsy Management in Rural Areas ", is led by the First Affiliated Hospital of Air Force Medical University, with Jiang Wen as the principal investigator. It is a prospective, multicenter, cluster-randomized controlled trial involving 756 patients from eight rural counties in China's northwest region. The study aims to evaluate the effectiveness of an AI-assisted remote healthcare system (via a WeChat mini-program) compared to standard care in reducing seizure frequency and improving self-management skills among adult epilepsy patients. Key components include patient and doctor interfaces for features like AI consultations, medication reminders, and online consultations. The trial runs from December 1, 2025, to November 30, 2027, with primary outcomes measured at 12 months and secondary outcomes assessing medication adherence, quality of life, and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Meets ILAE 2017 diagnostic criteria for epilepsy.
- •≥1 bilateral tonic-clonic seizure in the past 12 months.
- •Aged 18-65 years.
- •Access to a smartphone patient/caregiver.
- •Written informed consent.
排除标准
- •Pregnancy, lactation, or planned pregnancy.
- •Seizures with identifiable triggers e.g., alcohol withdrawal.
- •Allergy to phenobarbital/sodium valproate.
- •Severe comorbidities e.g., organ dysfunction, malignancy, psychiatric disorders.
研究组 & 干预措施
Enhanced Management with Mobile App
干预措施: AI-enabled WeChat mini-program "Epilepsy Smart Monitoring and Diagnosis System": (Device)
Standard Rural Epilepsy Management
结局指标
主要结局
Seizure change
时间窗: 12 months
Evaluation method: Calculate by comparing the frequency of attacks during the baseline period (12 months before enrollment) with the monthly average frequency of attacks during the intervention period (12 months)
Epilepsy Self Management Scale Score
时间窗: 12 months
Evaluation method: The Chinese version of the Epilepsy Self Management Scale was used. This scale includes multiple dimensions (such as drug management, information management, safety management, etc.), and a higher total score indicates stronger self-management ability.
次要结局
未报告次要终点