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Managing Epilepsy Well- WebEase Project

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Colleen K Diiorio, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00726076
First received: July 29, 2008
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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 Intervention
Epilepsy
Behavioral: WebEase

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Managing Epilepsy Well: Self-Management Intervention Research-Coordinating Center

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Epilepsy self-management: medication adherence, stress level, and sleep quality [ Time Frame: Baseline- 6 weeks- 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seizure frequency [ Time Frame: Baseline- 6 weeks- 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 194
Study Start Date: July 2008
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Other Name: WebEase
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726076

Locations
United States, Georgia
Rollins School of Public Health, Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Colleen DiIorio, PhD, RN Rollins School of Public Health, Emory University
  More Information

Additional Information:
Publications:
Responsible Party: Colleen K Diiorio, PhD, Professor Emerita, Emory University
ClinicalTrials.gov Identifier: NCT00726076     History of Changes
Other Study ID Numbers: IRB00006628, 5 U48 DP00004304
Study First Received: July 29, 2008
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Epilepsy
Medication
Stress
Sleep
Lifestyle Management

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 25, 2014