Managing Epilepsy Well- WebEase Project

• ClinicalTrials.gov Identifier: NCT00726076
• Recruitment Status: Completed
• First Posted: July 31, 2008
• Last Update Posted: December 11, 2013
• Sponsor: Emory University
• Collaborator: Centers for Disease Control and Prevention
• Information provided by (Responsible Party): Colleen K Diiorio, PhD, Emory University

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Locations

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

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

More Information

Publications of Results:

DiIorio C, Bamps Y, Walker ER, Escoffery C. Results of a research study evaluating WebEase, an online epilepsy self-management program. Epilepsy Behav. 2011 Nov;22(3):469-74. doi: 10.1016/j.yebeh.2011.07.030. Epub 2011 Sep 1.

Other Publications:

Walker ER, Bamps Y, Burdett A, Rothkopf J, Diiorio C. Social support for self-management behaviors among people with epilepsy: a content analysis of the WebEase program. Epilepsy Behav. 2012 Mar;23(3):285-90. doi: 10.1016/j.yebeh.2012.01.006. Epub 2012 Feb 23.

• 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
• 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:

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases