EpilepsyNCT00726076
Managing Epilepsy Well- WebEase Project
A study testing WebEase in people with Epilepsy, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- WebEase
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rollins School of Public Health, Emory University
Atlanta, Georgia, 30322
About this study
Official title: Managing Epilepsy Well: Self-Management Intervention Research-Coordinating Center
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- WebEase
- Keywords
- Epilepsy, Medication, Stress, Sleep, Lifestyle Management
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WebEaseBehavioural
Computer-based epilepsy self-management program
The Treatment Group received the WebEase Intervention immediately after completing the Baseline Assessment
WebEaseBehavioural
Control Group also received the WebEase Intervention. However, Control Group participants began the Intervention 6 weeks after completing the Baseline Assessment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The Treatment Group received the WebEase Intervention immediately after completing the Baseline Assessment. Receives: Behavioral: WebEase |
| Control | Experimental | Control Group also received the WebEase Intervention. However, Control Group participants began the Intervention 6 weeks after completing the Baseline Assessment. Receives: Behavioral: WebEase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epilepsy self-management: medication adherence, stress level, and sleep quality
Measured: Baseline- 6 weeks- 12 weeks
Secondary outcomes (1)
Seizure frequency
Measured: Baseline- 6 weeks- 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Colleen K Diiorio, PhD, Emory University
- Investigators
- Colleen DiIorio, PhD, RN, Principal investigator, Rollins School of Public Health, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726076
- Sponsor's protocol ID
- IRB00006628
- Other IDs
- 5 U48 DP00004304
- Status last verified
- Dec 2013
- First submitted
- 29 Jul 2008
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22364762DiIorio 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.
PubMed 21889413
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Epilepsy Well: Self-Management Intervention Research-Coordinating Center
- ClinicalTrials.gov ID
- NCT00726076
- Acronym / sponsor ID
- IRB00006628
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Medication, Stress, Sleep, Lifestyle Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Jul 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 31 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: WebEaseThe Treatment Group received the WebEase Intervention immediately after completing the Baseline Assessment. |
| Control | Experimental | Behavioral: WebEaseControl Group also received the WebEase Intervention. However, Control Group participants began the Intervention 6 weeks after completing the Baseline Assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WebEaseComputer-based epilepsy self-management program The Treatment Group received the WebEase Intervention immediately after completing the Baseline Assessment | Behavioural | Treatment |
| WebEaseControl Group also received the WebEase Intervention. However, Control Group participants began the Intervention 6 weeks after completing the Baseline Assessment. | Behavioural | Control |
Primary outcome
Epilepsy self-management: medication adherence, stress level, and sleep quality
Time frame: Baseline- 6 weeks- 12 weeks
1 secondary outcome
Seizure frequency
Time frame: Baseline- 6 weeks- 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Background: PubMed 22364762Walker 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 publication: PubMed 21889413DiIorio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen DiIorio, PhD, RN principal investigator
Rollins School of Public Health, Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WebEase in people with Epilepsy, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epilepsy self-management: medication adherence, stress level, and sleep quality (time frame: Baseline- 6 weeks- 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00726076, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.