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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: WebEase Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Managing Epilepsy Well: Self-Management Intervention Research-Coordinating Center
Study Start Date : July 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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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
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
Control Group also received the WebEase Intervention. However, Control Group participants began the Intervention 6 weeks after completing the Baseline Assessment.


Outcome Measures
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Primary Outcome Measures :
  1. Epilepsy self-management: medication adherence, stress level, and sleep quality [ Time Frame: Baseline- 6 weeks- 12 weeks ]

Secondary Outcome Measures :
  1. Seizure frequency [ Time Frame: Baseline- 6 weeks- 12 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00726076


Locations
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United States, Georgia
Rollins School of Public Health, Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Colleen DiIorio, PhD, RN Rollins School of Public Health, Emory University
More Information
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Additional Information:
WebEase Information Site  This link exits the ClinicalTrials.gov site

Publications of Results:

Other Publications:

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Responsible Party: Colleen K Diiorio, PhD, Professor Emerita, Emory University
ClinicalTrials.gov Identifier: NCT00726076    
Other Study ID Numbers: IRB00006628
5 U48 DP00004304 ( Other Identifier: Other )
First Posted: July 31, 2008    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013
Keywords provided by Colleen K Diiorio, PhD, Emory University:
Epilepsy
Medication
Stress
Sleep
Lifestyle Management
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases