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Managing Epilepsy Well- WebEase Project

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WebEase
WebEase
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy focused on measuring Epilepsy, Medication, Stress, Sleep, Lifestyle Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rollins School of Public Health, Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment

Control

Arm Description

The Treatment Group received the WebEase Intervention immediately after completing the Baseline Assessment.

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

Outcomes

Primary Outcome Measures

Epilepsy self-management: medication adherence, stress level, and sleep quality

Secondary Outcome Measures

Seizure frequency

Full Information

First Posted
July 29, 2008
Last Updated
December 10, 2013
Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00726076
Brief Title
Managing Epilepsy Well- WebEase Project
Official Title
Managing Epilepsy Well: Self-Management Intervention Research-Coordinating Center
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Medication, Stress, Sleep, Lifestyle Management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
The Treatment Group received the WebEase Intervention immediately after completing the Baseline Assessment.
Arm Title
Control
Arm Type
Experimental
Arm Description
Control Group also received the WebEase Intervention. However, Control Group participants began the Intervention 6 weeks after completing the Baseline Assessment.
Intervention Type
Behavioral
Intervention Name(s)
WebEase
Intervention Description
Computer-based epilepsy self-management program The Treatment Group received the WebEase Intervention immediately after completing the Baseline Assessment
Intervention Type
Behavioral
Intervention Name(s)
WebEase
Intervention Description
Control Group also received the WebEase Intervention. However, Control Group participants began the Intervention 6 weeks after completing the Baseline Assessment.
Primary Outcome Measure Information:
Title
Epilepsy self-management: medication adherence, stress level, and sleep quality
Time Frame
Baseline- 6 weeks- 12 weeks
Secondary Outcome Measure Information:
Title
Seizure frequency
Time Frame
Baseline- 6 weeks- 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen DiIorio, PhD, RN
Organizational Affiliation
Rollins School of Public Health, Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rollins School of Public Health, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22364762
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.
Results Reference
background
PubMed Identifier
21889413
Citation
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.
Results Reference
result

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Managing Epilepsy Well- WebEase Project

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