Epilepsy Prevalence and Intervention Study in Zhejiang Province, China

Study Overview
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Brief Summary
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To carry out the epidemiological investigation on epilepsy in Zhejiang Province, China, and then establish early comprehensive intervention to help patients with epilepsy to improve seizure control and the quality of life.

Detailed Description
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To carry out the epidemiological investigation on epilepsy in Zhejiang Province, China, and then establish early comprehensive intervention（proper antiepileptic drugs and education intervention） to help patients with epilepsy to improve seizure control and the quality of life.

Official Title
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Epilepsy Prevalence and Intervention Study in Zhejiang Province, China

Conditions
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Epilepsy

Intervention / Treatment
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* Behavioral: education on epilepsy
* Drug: routine and proper antiepileptic drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed and untreated epilepsy; Aged 14 and above; Sign the informed consents. Exclusion Criteria: With intellectual development disorder; With serious heart and lung diseases.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomly group into two
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Routine AED group<br>Routine and proper antiepileptic drugs group | Drug: routine and proper antiepileptic drugs<br>* routine and proper antiepileptic drugs<br>|
| Experimental: B: AED and education group<br>Routine, proper antiepileptic drugs and education group | Behavioral: education on epilepsy<br>* education on epilepsy, including epilepsy diary, pamphlet，discussion between patients and phone visits and so on<br>Drug: routine and proper antiepileptic drugs<br>* routine and proper antiepileptic drugs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline seizures frequency 1 | change from baseline seizures frequency at 12 months, seizure frequency is defined as the number of seizure attacks during 3 months before baseline or endpoint) | 12 months | 
| Change from baseline seizures frequency 2 | change from baseline seizures frequency at 24 months, seizure frequency is defined as the number of seizure attacks during 3 months before baseline or endpoint) | 24 months | 
| Occurrence of refractory epilepsy | occurrence of refractory epilepsy at 24 months | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (QOL scales) | Quality of Life Scale, high scores mean a better outcome | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epilepsy prevalence, intervention