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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07448233
Enrollment
20
Registered
2026-03-04
Start date
2025-12-01
Completion date
2027-11-30
Last updated
2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsies, Remote Management of Epilepsy in Rural Areas

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.

Interventions

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

Patient Module: Real-time monitoring, medication reminders, AI consultations, seizure logging, educational resources. Physician Module: AI-assisted diagnostics, online consultations, data analytics dashboard.

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Seizure change12 monthsEvaluation 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 Score12 monthsEvaluation 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026