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

NCT07448233 | Enrolling By Invitation

• 1 other identifier: XJLL-KY-20252555
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsies; Remote Management of Epilepsy in Rural Areas

Outcome Measures

Primary Outcomes (2)

• Seizure change

  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)

  12 months

• Epilepsy Self Management Scale Score

  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.

  12 months

Study Arms (2)

Standard Rural Epilepsy Management

NO INTERVENTION

Enhanced Management with Mobile App

EXPERIMENTAL

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

Interventions

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.

Enhanced Management with Mobile App

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Department of Neurology, Xijing Hospital, Air Force Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: March 4, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: March 4, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)