Managing Epilepsy Well- WebEase Project
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ClinicalTrials.gov Identifier: NCT00726076 |
Recruitment Status
:
Completed
First Posted
: July 31, 2008
Last Update Posted
: December 11, 2013
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Tracking Information | ||||
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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 |
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 |
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. |
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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 |
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Condition ICMJE | Epilepsy | |||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
194 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 ) |
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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 |
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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 |