Epilepsy Enhanced Care

NCT07709481 | Not Yet Recruiting

• 1 other identifier: CE5171
• Study Type: interventional
• Target: 166
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes in scores on other seven domains of the HLQ

  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

Other Outcomes (1)

• Patient satisfaction score

  At 3 months after enrollment

Study Arms (3)

Index group (newly diagnosed epilepsy + intervention)

EXPERIMENTAL

Epilepsy Enhanced Care

Other: Epilepsy Enhanced Care

Control group 1 (newly diagnosed epilepsy, standard care only)

NO INTERVENTION

Control group 2 (established epilepsy, standard care only, cross-sectional)

NO INTERVENTION

Interventions

Epilepsy Enhanced Care OTHER

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.

Index group (newly diagnosed epilepsy + intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Confirmed epilepsy diagnosis (ILAE criteria);
• Ability to provide informed consent (or legal representative);
• Sufficient Italian proficiency.

You may not qualify if:

• Previous participation in a structured epilepsy education program;
• Severe untreated comorbidities precluding attendance.

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead
• Pamela Agazzi: collaborator

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07