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Managing Epilepsy Well- WebEase Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00726076
Recruitment Status : Completed
First Posted : July 31, 2008
Last Update Posted : December 11, 2013
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Colleen K Diiorio, PhD, Emory University

Tracking Information
First Submitted Date  ICMJE July 29, 2008
First Posted Date  ICMJE July 31, 2008
Last Update Posted Date December 11, 2013
Study Start Date  ICMJE July 2008
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2008)
Epilepsy self-management: medication adherence, stress level, and sleep quality [ Time Frame: Baseline- 6 weeks- 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00726076 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2008)
Seizure frequency [ Time Frame: Baseline- 6 weeks- 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Managing Epilepsy Well- WebEase Project
Official Title  ICMJE Managing Epilepsy Well: Self-Management Intervention Research-Coordinating Center
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2012)
194
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2008)
320
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00726076
Other Study ID Numbers  ICMJE IRB00006628
5 U48 DP00004304 ( Other Identifier: Other )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Colleen K Diiorio, PhD, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Colleen DiIorio, PhD, RN Rollins School of Public Health, Emory University
PRS Account Emory University
Verification Date December 2013

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