Epilepsy Prevalence and Intervention Study in Zhejiang Province, China

July 13, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shengzhou, China
        • Completed
        • Shengzhou People's Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months
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)
24 months
Occurrence of refractory epilepsy
Time Frame: 24 months
occurrence of refractory epilepsy at 24 months
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

The Central Hospital of Lishui City
The Second Affiliated Hospital of Jiaxing University
Shengzhou People's Hospital
Hangzhou Center of Disease Control and Prevention
Children's Hospital Affiliated to Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 13, 2013

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (ACTUAL)

June 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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