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.

Study Overview

• Status: Not yet recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Other: Epilepsy Enhanced Care

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Index group (newly diagnosed epilepsy + intervention); Epilepsy Enhanced Care	Other: 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.
No Intervention: Control group 1 (newly diagnosed epilepsy, standard care only)
No Intervention: Control group 2 (established epilepsy, standard care only, cross-sectional)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in health literacy	Measured using Domain 2 ("Having sufficient information to manage my health") of the Health Literacy Questionnaire (HLQ).	From baseline to 3 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in scores on other seven domains of the HLQ	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		From baseline to 3 and 12 months after enrollment
Change in Epilepsy Self-Management score		From baseline to 3 and 12 months after enrollment
Change in Generalized Anxiety Disorder 7 score		From baseline to 3 and 12 months after enrollment
Change in Neurological Disorders Depression Inventory for Epilepsy score		From baseline to 3 and 12 months after enrollment
Healthcare utilization	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

Other Outcome Measures

Outcome Measure	Time Frame
Patient satisfaction score	At 3 months after enrollment

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Cantonale, Bellinzona
• Collaborators: Pamela Agazzi

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: July 12, 2026
• First Submitted That Met QC Criteria: July 12, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: CE5171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No