- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00726076
Managing Epilepsy Well- WebEase Project
Managing Epilepsy Well: Self-Management Intervention Research-Coordinating Center
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30322
- Rollins School of Public Health, Emory University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Epilepsy self-management: medication adherence, stress level, and sleep quality
Tidsramme: Baseline- 6 weeks- 12 weeks
|
Baseline- 6 weeks- 12 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Seizure frequency
Tidsramme: Baseline- 6 weeks- 12 weeks
|
Baseline- 6 weeks- 12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Colleen DiIorio, PhD, RN, Rollins School of Public Health, Emory University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00006628
- 5 U48 DP00004304 (Annen identifikator: Other)
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