Managing Epilepsy Well- WebEase Project

December 10, 2013 updated by: Colleen K Diiorio, PhD, Emory University

Managing Epilepsy Well: Self-Management Intervention Research-Coordinating Center

The purpose of this study is to test a computer program for people with epilepsy. The program was developed to help people with epilepsy improve their self-management skills for taking medications, reducing stress, and sleeping well.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

WebEase is an internet self-management program for people with epilepsy. Our goal is to offer a program that supports the management of epilepsy by people with epilepsy. The program is based on proven techniques of motivational interviewing and stages of change. Before offering WebEase to the general public, we tested the program among volunteers with epilepsy. We recruited individuals with epilepsy who were willing to use the program.

The program was developed by a team of researchers and physicians who treat patients with epilepsy. The program offers information on three major topics: 1) medication taking, 2) stress and 3) sleep management as it relates to epilepsy. It includes quizzes, fact sheets, and links to other authoritative websites on epilepsy.

Before beginning the study, each participant completed a brief survey about medications, stress, and sleep. Then participants worked through the WebEase program. WebEase consists of three modules: medication, stress, and sleep. Each module lasts 2 weeks, and includes an interactive session geared specifically to each person's needs. During the study, each participant kept a diary of medications, stress, sleep, and seizures, which allowed them to see changes over time. After completing the WebEase program, participants completed two more brief surveys about six weeks apart. About half of the participants were asked to complete two surveys about 6 weeks apart before beginning the WebEase program. These individuals completed one survey after the end of the program.

Study Type

Interventional

Enrollment (Actual)

194

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 Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Rollins School of Public Health, Emory University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be 18 years of age or older
  • Understand and speak English
  • Have been diagnosed with epilepsy
  • Have been on an antiepileptic medication (AED) for at least 3 months
  • Have access to the internet
  • Be willing to participate
  • Have not participated in WebEase in the past

Exclusion Criteria:

  • Under age 18
  • Unable to understand and speak English
  • Have NOT been diagnosed with epilepsy
  • Have NOT been on an AED for at least 3 months
  • Not willing to participate
  • Have participated in WebEase in the past

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
The Treatment Group received the WebEase Intervention immediately after completing the Baseline Assessment.
Behavioral: WebEase

Computer-based epilepsy self-management program

The Treatment Group received the WebEase Intervention immediately after completing the Baseline Assessment

Behavioral: WebEase
Control Group also received the WebEase Intervention. However, Control Group participants began the Intervention 6 weeks after completing the Baseline Assessment.
Experimental: Control
Control Group also received the WebEase Intervention. However, Control Group participants began the Intervention 6 weeks after completing the Baseline Assessment.
Behavioral: WebEase

Computer-based epilepsy self-management program

The Treatment Group received the WebEase Intervention immediately after completing the Baseline Assessment

Behavioral: WebEase
Control Group also received the WebEase Intervention. However, Control Group participants began the Intervention 6 weeks after completing the Baseline Assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Epilepsy self-management: medication adherence, stress level, and sleep quality
Time Frame: Baseline- 6 weeks- 12 weeks
Baseline- 6 weeks- 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Seizure frequency
Time Frame: Baseline- 6 weeks- 12 weeks
Baseline- 6 weeks- 12 weeks

Collaborators and Investigators

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

Sponsor

Emory University

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Colleen DiIorio, PhD, RN, Rollins School of Public Health, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

July 29, 2008

First Submitted That Met QC Criteria

July 30, 2008

First Posted (Estimate)

July 31, 2008

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00006628
  • 5 U48 DP00004304 (Other Identifier: Other)

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.

Clinical Trials on Epilepsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe