Epilepsy Enhanced Care
Evaluating the Impact of Epilepsy Enhanced Care on Health Literacy in People With Epilepsy: A Nurse-led Educational Intervention Study
Background: Epilepsy is a common brain condition that causes repeated seizures. People with epilepsy often need a lot of information to manage their health, but many do not receive enough education about their condition. Having good health literacy (the ability to find, understand, and use health information) is important for managing epilepsy well.
Objective: This study aims to test whether a special educational program led by a trained epilepsy nurse, called "Epilepsy Enhanced Care," helps adults with epilepsy better understand and manage their health.
Study design: This is a prospective, non-randomized, controlled study involving adults (aged 18 years or older) with epilepsy. Participants will be divided into three groups:
- Intervention group: Patients with newly diagnosed epilepsy who will receive the "Epilepsy Enhanced Care" educational program in addition to their usual care.
- Control group 1: Patients with newly diagnosed epilepsy who will receive only their usual care.
- Control group 2: Patients who have had epilepsy for at least one year and will receive only their usual care.
Intervention: The "Epilepsy Enhanced Care" program is a structured, one-on-one educational session delivered by a specialized epilepsy nurse within 2 months of diagnosis. The session covers topics such as epilepsy types, medications, safety planning, and lifestyle management. Patients and their caregivers may attend together. After the session, participants can contact the nurse by phone or email with further questions.
Outcomes: The main outcome is the change in health literacy from the start of the study to 3 months after the intervention. Secondary outcomes include changes in epilepsy-specific knowledge, self-management skills, quality of life, anxiety, depression symptoms, and how often patients use healthcare services.
Study duration: Participants in the intervention group and control group 1 will be followed for 12 months. Participants in control group 2 will be assessed at a single time point. The entire study is expected to take 24 months.
Risks and benefits: The intervention involves only education and counseling, with no medications or medical devices. The risks are minimal, and participation is voluntary.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age ≥18 years;
- Confirmed epilepsy diagnosis (ILAE criteria);
- Ability to provide informed consent (or legal representative);
- Sufficient Italian proficiency.
Exclusion Criteria:
- Previous participation in a structured epilepsy education program;
- Severe untreated comorbidities precluding attendance.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Index group (newly diagnosed epilepsy + intervention)
Epilepsy Enhanced Care
|
A structured, nurse-led educational program delivered by a specialized epilepsy nurse.
Includes a comprehensive consultation (within 2 months after diagnosis) covering epilepsy types, anti-seizure medications, safety planning, lifestyle management.
Caregivers encouraged to attend.
Follow-up access via telephone/email.
|
|
Sin intervención: Control group 1 (newly diagnosed epilepsy, standard care only)
|
|
|
Sin intervención: Control group 2 (established epilepsy, standard care only, cross-sectional)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Improvement in health literacy
Periodo de tiempo: From baseline to 3 months after enrollment
|
Measured using Domain 2 ("Having sufficient information to manage my health") of the Health Literacy Questionnaire (HLQ).
|
From baseline to 3 months after enrollment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in scores on other seven domains of the HLQ
Periodo de tiempo: From baseline to 3 and 12 months after enrollment
|
For each endpoint, the change in score from baseline to follow-up will be measured in the intervention groups, and scores will be compared between the intervention and control groups at follow-up
|
From baseline to 3 and 12 months after enrollment
|
|
Change in Epilepsy-specific knowledge score
Periodo de tiempo: From baseline to 3 and 12 months after enrollment
|
From baseline to 3 and 12 months after enrollment
|
|
|
Change in Epilepsy Self-Management score
Periodo de tiempo: From baseline to 3 and 12 months after enrollment
|
From baseline to 3 and 12 months after enrollment
|
|
|
Change in Generalized Anxiety Disorder 7 score
Periodo de tiempo: From baseline to 3 and 12 months after enrollment
|
From baseline to 3 and 12 months after enrollment
|
|
|
Change in Neurological Disorders Depression Inventory for Epilepsy score
Periodo de tiempo: From baseline to 3 and 12 months after enrollment
|
From baseline to 3 and 12 months after enrollment
|
|
|
Healthcare utilization
Periodo de tiempo: From baseline to 3 and 12 months after enrollment
|
Frequency of epilepsy-related emergency department visits, epilepsy-related hospitalizations, and unscheduled neurology consultations, collected through patient self-report and, where available, verified through electronic medical records.
|
From baseline to 3 and 12 months after enrollment
|
Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Patient satisfaction score
Periodo de tiempo: At 3 months after enrollment
|
At 3 months after enrollment
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CE5171
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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