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NCT Number: NCT07709481

Epilepsy Enhanced Care

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Improvement in health literacy

    Time frame: From baseline to 3 months after enrollment

    Measured using Domain 2 ("Having sufficient information to manage my health") of the Health Literacy Questionnaire (HLQ).

Secondary outcomes

  1. Changes in scores on other seven domains of the HLQ

    Time frame: 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

  2. Change in Epilepsy-specific knowledge score

    Time frame: From baseline to 3 and 12 months after enrollment

  3. Change in Epilepsy Self-Management score

    Time frame: From baseline to 3 and 12 months after enrollment

  4. Change in Generalized Anxiety Disorder 7 score

    Time frame: From baseline to 3 and 12 months after enrollment

  5. Change in Neurological Disorders Depression Inventory for Epilepsy score

    Time frame: From baseline to 3 and 12 months after enrollment

  6. Healthcare utilization

    Time frame: 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.

Other outcomes

  1. Patient satisfaction score

    Time frame: At 3 months after enrollment

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Other

Collaborators

  • Pamela Agazzi

Registry information

Official study title

Evaluating the Impact of Epilepsy Enhanced Care on Health Literacy in People With Epilepsy: A Nurse-led Educational Intervention Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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