Managing Epilepsy Well- WebEase Project

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726076
• Other study ID #: IRB00006628
• Secondary ID: 5 U48 DP00004304
• Status: Completed
• Phase: N/A
• First received: July 29, 2008
• Last updated: December 10, 2013
• Start date: July 2008
• Est. completion date: November 2010

Study information

• Verified date: December 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: November 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Epilepsy

Intervention

Behavioral:
• WebEase
Computer-based epilepsy self-management program The Treatment Group received the WebEase Intervention immediately after completing the Baseline Assessment
• WebEase
Control Group also received the WebEase Intervention. However, Control Group participants began the Intervention 6 weeks after completing the Baseline Assessment.

Locations

Country	Name	City	State
United States	Rollins School of Public Health, Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epilepsy self-management: medication adherence, stress level, and sleep quality		Baseline- 6 weeks- 12 weeks	No
Secondary	Seizure frequency		Baseline- 6 weeks- 12 weeks	No

External Links

•   WebEase Information Site