Application of an AI-Based Health Management System in Long-Term Epilepsy Management in Rural Areas
Phase: NA
Conditions: Epilepsies, Remote Management of Epilepsy in Rural Areas
Sponsor: Xijing Hospital

Application of an AI-Based Health Management
System in Long-Term Epilepsy Management in
Rural Areas
Sponsor: The First Affiliated Hospital of Air Force Medical University
Study Duration: December 1, 2025 – November 30, 2027
Project number: XJLL-KY-20252555
Document Date: December 15, 2025

Study Objectives

Primary:

Evaluate the efficacy of an AI-assisted telemedicine system versus
conventional management in reducing seizure frequency and improving
self-management capabilities among rural epilepsy patients.

Secondary:

Assess impacts on medication adherence, health status, quality of life QoL,
safety, and user acceptance.
Study Design

Type: Prospective, multicenter, cluster-randomized controlled trial.

Sample Size: 756 participants.

Randomization:
Clusters health centers randomized by patient volume large/medium/small.
Central randomization via an independent data center.

Blinding: Participants, intervention administrators, outcome assessors, and
statisticians are blinded.
Intervention

Control Group:

Conventional management monthly follow−ups, paper seizure diaries, patient
education.

Intervention Group:


Conventional management + AI-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.
Participant Selection

Inclusion Criteria:
i.
Meets ILAE 2017 diagnostic criteria for epilepsy.
ii.
≥1 bilateral tonic-clonic seizure in the past 12 months.
iii.
Aged 18–65 years.
iv.
Access to a smartphone patient/caregiver.
v.
Written informed consent.

Exclusion Criteria:
i.
Pregnancy, lactation, or planned pregnancy.
ii.
Seizures with identifiable triggers e.g., alcohol withdrawal.
iii.
Allergy to phenobarbital/sodium valproate.
iv.
Severe comorbidities e.g., organ dysfunction, malignancy, psychiatric
disorders.
Outcome Measures
Category
Tool/Method
Assessment Timepoints
Primary
- Seizure reduction
≥50% reduction from baseline
Month 12
- Self-management
Epilepsy Self-Management Scale ESMS
Baseline, Month 12
Secondary
- Seizure frequency
Monthly seizure rate
Months 3, 6, 9, 12
- Medication adherence
Morisky Scale + pill count
Baseline, Months 3, 6, 9, 12
- Depression
Patient Health Questionnaire-9 PHQ−9
Baseline, Months 3, 6, 9, 12
- QoL
Quality of Life in Epilepsy-10 QOLIE−10
Baseline, Months 3, 6, 9, 12

Category
Tool/Method
Assessment Timepoints
Safety
Adverse events AEs/Serious AEs SAEs
Monthly
Acceptance
Satisfaction survey patients/physicians
Month 12
Statistical Analysis

Software: SPSS 25.0.

Methods: T-test, U-test, χ², Mann-Whitney U.

Significance: P < 0.05 two−tailed.

Analysis Sets:
Intention-to-treat ITT for efficacy.
Safety set all receiving≥1 intervention.
Ethics & Compliance

Approved by the Institutional Review Board IRB.

Adheres to the Declaration of Helsinki.

All participants provide informed consent.

Data anonymization and confidentiality maintained.
Study Workflow
1. Preparation Dec2025–Feb2026:
Mini-program optimization.
Cluster randomization, participant screening, baseline data collection.
2. Intervention Mar2026–Feb2027:
12-month intervention with monthly follow-ups.
Real-time AE monitoring.
3. Data Analysis Mar–May2027:
Database lock and statistical analysis.
4. Reporting Jun–Nov2027:
Manuscript and final study report preparation.
AI Model Validation

Accuracy Metrics:
BLEU/ROUGE scores textsimilarity.
Expert evaluation factual correctness, safety, completeness, absence of
hallucinations.

Clinical Validation:
IIa trial (N = 120): 6-month seizure-free rate.
IIb cRCT (N = 300): AI-assisted vs. conventional surgery.
Quality Assurance

Training: All staff certified in protocol and GCP.

Data Integrity:
Case Report Forms CRFs audited within 24 hours.
Double verification for primary endpoints.


Oversight:
Quarterly on-site monitoring.
Independent Data Safety Monitoring Board DSMB for interim analysis.