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Managing Epilepsy Well- WebEase Project

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Colleen K Diiorio, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00726076
First received: July 29, 2008
Last updated: December 10, 2013
Last verified: December 2013
History of Changes

July 29, 2008
December 10, 2013
July 2008
October 2010   (final data collection date for primary outcome measure)
Epilepsy self-management: medication adherence, stress level, and sleep quality [ Time Frame: Baseline- 6 weeks- 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00726076 on ClinicalTrials.gov Archive Site
Seizure frequency [ Time Frame: Baseline- 6 weeks- 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Managing Epilepsy Well- WebEase Project
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Epilepsy
  • Behavioral: WebEase

    Computer-based epilepsy self-management program

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

    Other Name: WebEase
  • Behavioral: WebEase
    Control Group also received the WebEase Intervention. However, Control Group participants began the Intervention 6 weeks after completing the Baseline Assessment.
  • Experimental: Treatment
    The Treatment Group received the WebEase Intervention immediately after completing the Baseline Assessment.
    Intervention: Behavioral: WebEase
  • Experimental: Control
    Control Group also received the WebEase Intervention. However, Control Group participants began the Intervention 6 weeks after completing the Baseline Assessment.
    Intervention: Behavioral: WebEase

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
194
November 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00726076
IRB00006628, 5 U48 DP00004304
No
Colleen K Diiorio, PhD, Emory University
Emory University
Centers for Disease Control and Prevention
Principal Investigator: Colleen DiIorio, PhD, RN Rollins School of Public Health, Emory University
Emory University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP