Managing Epilepsy Well- WebEase Project

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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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 *	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.; 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.
* 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	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	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	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	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