- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00726076
Managing Epilepsy Well- WebEase Project
Managing Epilepsy Well: Self-Management Intervention Research-Coordinating Center
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30322
- Rollins School of Public Health, Emory University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Epilepsy self-management: medication adherence, stress level, and sleep quality
Periodo de tiempo: Baseline- 6 weeks- 12 weeks
|
Baseline- 6 weeks- 12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Seizure frequency
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00006628
- 5 U48 DP00004304 (Otro identificador: Other)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .