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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Inget ingripande: Control group 1 (newly diagnosed epilepsy, standard care only)
|
|
|
Inget ingripande: Control group 2 (established epilepsy, standard care only, cross-sectional)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Improvement in health literacy
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in scores on other seven domains of the HLQ
Tidsram: 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
Tidsram: From baseline to 3 and 12 months after enrollment
|
From baseline to 3 and 12 months after enrollment
|
|
|
Change in Epilepsy Self-Management score
Tidsram: 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
Tidsram: 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
Tidsram: From baseline to 3 and 12 months after enrollment
|
From baseline to 3 and 12 months after enrollment
|
|
|
Healthcare utilization
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Patient satisfaction score
Tidsram: At 3 months after enrollment
|
At 3 months after enrollment
|
Samarbetspartners och utredare
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CE5171
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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