- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00726076
Managing Epilepsy Well- WebEase Project
Managing Epilepsy Well: Self-Management Intervention Research-Coordinating Center
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Georgia
-
Atlanta, Georgia, Stati Uniti, 30322
- Rollins School of Public Health, Emory University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Epilepsy self-management: medication adherence, stress level, and sleep quality
Lasso di tempo: Baseline- 6 weeks- 12 weeks
|
Baseline- 6 weeks- 12 weeks
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Seizure frequency
Lasso di tempo: Baseline- 6 weeks- 12 weeks
|
Baseline- 6 weeks- 12 weeks
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Colleen DiIorio, PhD, RN, Rollins School of Public Health, Emory University
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB00006628
- 5 U48 DP00004304 (Altro identificatore: Other)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .