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Epilepsy Prevalence and Intervention Study in Zhejiang Province, China

Primary Purpose

Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
education on epilepsy
routine and proper antiepileptic drugs
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Epilepsy focused on measuring epilepsy prevalence, intervention

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting
  • Shengzhou People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A: Routine AED group

B: AED and education group

Arm Description

Routine and proper antiepileptic drugs group

Routine, proper antiepileptic drugs and education group

Outcomes

Primary Outcome Measures

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)
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)
Occurrence of refractory epilepsy
occurrence of refractory epilepsy at 24 months

Secondary Outcome Measures

Quality of life (QOL scales)
Quality of Life Scale, high scores mean a better outcome

Full Information

First Posted
June 8, 2021
Last Updated
July 13, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Hangzhou Center of Disease Control and Prevention, The Central Hospital of Lishui City, The Second Affiliated Hospital of Jiaxing University, Shengzhou People's Hospital, Children's Hospital Affiliated to Zhejiang University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04944641
Brief Title
Epilepsy Prevalence and Intervention Study in Zhejiang Province, China
Official Title
Epilepsy Prevalence and Intervention Study in Zhejiang Province, China
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 13, 2013 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Hangzhou Center of Disease Control and Prevention, The Central Hospital of Lishui City, The Second Affiliated Hospital of Jiaxing University, Shengzhou People's Hospital, Children's Hospital Affiliated to Zhejiang University School of Medicine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
epilepsy prevalence, intervention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomly group into two
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: Routine AED group
Arm Type
Experimental
Arm Description
Routine and proper antiepileptic drugs group
Arm Title
B: AED and education group
Arm Type
Experimental
Arm Description
Routine, proper antiepileptic drugs and education group
Intervention Type
Behavioral
Intervention Name(s)
education on epilepsy
Intervention Description
education on epilepsy, including epilepsy diary, pamphlet，discussion between patients and phone visits and so on
Intervention Type
Drug
Intervention Name(s)
routine and proper antiepileptic drugs
Intervention Description
routine and proper antiepileptic drugs
Primary Outcome Measure Information:
Title
Change from baseline seizures frequency 1
Description
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)
Time Frame
12 months
Title
Change from baseline seizures frequency 2
Description
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)
Time Frame
24 months
Title
Occurrence of refractory epilepsy
Description
occurrence of refractory epilepsy at 24 months
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Quality of life (QOL scales)
Description
Quality of Life Scale, high scores mean a better outcome
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mei-ping Ding
Phone
13588058581
Email
dmp-neurology@zju.edu.cn
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei-ping Ding
Phone
13588058581
Email
dmp-neurology@zju.edu.cn
Facility Name
Shengzhou People's Hospital
City
Shengzhou
Country
China
Individual Site Status
Completed

12. IPD Sharing Statement

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Epilepsy Prevalence and Intervention Study in Zhejiang Province, China

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