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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Index group (newly diagnosed epilepsy + intervention)
Epilepsy Enhanced Care
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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.
|
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Geen tussenkomst: Control group 1 (newly diagnosed epilepsy, standard care only)
|
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Geen tussenkomst: Control group 2 (established epilepsy, standard care only, cross-sectional)
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Improvement in health literacy
Tijdsspanne: From baseline to 3 months after enrollment
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Measured using Domain 2 ("Having sufficient information to manage my health") of the Health Literacy Questionnaire (HLQ).
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From baseline to 3 months after enrollment
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in scores on other seven domains of the HLQ
Tijdsspanne: 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
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From baseline to 3 and 12 months after enrollment
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Change in Epilepsy-specific knowledge score
Tijdsspanne: From baseline to 3 and 12 months after enrollment
|
From baseline to 3 and 12 months after enrollment
|
|
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Change in Epilepsy Self-Management score
Tijdsspanne: From baseline to 3 and 12 months after enrollment
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From baseline to 3 and 12 months after enrollment
|
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Change in Generalized Anxiety Disorder 7 score
Tijdsspanne: From baseline to 3 and 12 months after enrollment
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From baseline to 3 and 12 months after enrollment
|
|
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Change in Neurological Disorders Depression Inventory for Epilepsy score
Tijdsspanne: From baseline to 3 and 12 months after enrollment
|
From baseline to 3 and 12 months after enrollment
|
|
|
Healthcare utilization
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Patient satisfaction score
Tijdsspanne: At 3 months after enrollment
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At 3 months after enrollment
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Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CE5171
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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