- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00726076
Managing Epilepsy Well- WebEase Project
Managing Epilepsy Well: Self-Management Intervention Research-Coordinating Center
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30322
- Rollins School of Public Health, Emory University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Treatment
The Treatment Group received the WebEase Intervention immediately after completing the Baseline Assessment.
|
Computer-based epilepsy self-management program 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.
|
|
Experimental: Control
Control Group also received the WebEase Intervention.
However, Control Group participants began the Intervention 6 weeks after completing the Baseline Assessment.
|
Computer-based epilepsy self-management program 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Epilepsy self-management: medication adherence, stress level, and sleep quality
Prazo: Baseline- 6 weeks- 12 weeks
|
Baseline- 6 weeks- 12 weeks
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Seizure frequency
Prazo: Baseline- 6 weeks- 12 weeks
|
Baseline- 6 weeks- 12 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Colleen DiIorio, PhD, RN, Rollins School of Public Health, Emory University
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB00006628
- 5 U48 DP00004304 (Outro identificador: Other)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .