Application of an AI-Based Health Management System in Long-Term Epilepsy Management in Rural Areas

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.

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Key information

Conditions

Epilepsies Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases Remote Management of Epilepsy in Rural Areas

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, Xijing Hospital, Air Force Medical University

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

AI-enabled WeChat mini-program "Epilepsy Smart Monitoring and Diagnosis System":

Device

Patient Module: Real-time monitoring, medication reminders, AI consultations, seizure logging, educational resources.

Physician Module: AI-assisted diagnostics, online consultations, data analytics dashboard.

Primary outcomes

Seizure change

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Mar 4, 2026
Registry last updated: Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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