Epilepsy Prevalence and Intervention Study in Zhejiang Province, China
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Occurrence of refractory epilepsy
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
A: Routine AED group
Routine and proper antiepileptic drugs group
Intervention: routine and proper antiepileptic drugs (Drug)
B: AED and education group
Routine, proper antiepileptic drugs and education group
Intervention: education on epilepsy (Behavioral)
B: AED and education group
Routine, proper antiepileptic drugs and education group
Intervention: routine and proper antiepileptic drugs (Drug)
Outcomes
Primary Outcomes
Occurrence of refractory epilepsy
Time Frame: 24 months
occurrence of refractory epilepsy at 24 months
Change from baseline seizures frequency 1
Time Frame: 12 months
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)
Change from baseline seizures frequency 2
Time Frame: 24 months
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)
Secondary Outcomes
- Quality of life (QOL scales)(2 year)