Epilepsy Prevalence and Intervention Study in Zhejiang Province, China
1 other identifier
interventional
200
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 13, 2013
CompletedFirst Submitted
Initial submission to the registry
June 8, 2021
CompletedFirst Posted
Study publicly available on registry
June 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJuly 19, 2021
July 1, 2021
9.1 years
June 8, 2021
July 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Quality of life (QOL scales)
2 year
Study Arms (2)
A: Routine AED group
EXPERIMENTALRoutine and proper antiepileptic drugs group
B: AED and education group
EXPERIMENTALRoutine, proper antiepileptic drugs and education group
Interventions
education on epilepsy, including epilepsy diary, pamphlet，discussion between patients and phone visits and so on
routine and proper antiepileptic drugs
Eligibility Criteria
You may qualify if:
- Newly diagnosed and untreated epilepsy; Aged 14 and above; Sign the informed consents.
You may not qualify if:
- With intellectual development disorder; With serious heart and lung diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitylead
- Hangzhou Center of Disease Control and Preventioncollaborator
- The Central Hospital of Lishui Citycollaborator
- The Second Affiliated Hospital of Jiaxing Universitycollaborator
- Zhejiang Universitycollaborator
- Children's Hospital Affiliated to Zhejiang University School of Medicinecollaborator
Study Sites (2)
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China
Shengzhou People's Hospital
Shengzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2021
First Posted
June 29, 2021
Study Start
September 13, 2013
Primary Completion
September 30, 2022
Study Completion
December 31, 2022
Last Updated
July 19, 2021
Record last verified: 2021-07