Epilepsy Enhanced Care

Sponsor
Ente Ospedaliero Cantonale, Bellinzona
Study ID
NCT07709481
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 16, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
166 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Index group (newly diagnosed epilepsy + intervention)
    Epilepsy Enhanced Care
  • No Intervention: Control group 1 (newly diagnosed epilepsy, standard care only)
  • No Intervention: Control group 2 (established epilepsy, standard care only, cross-sectional)

Primary Outcome Measure

Improvement in health literacy [ Time Frame: From baseline to 3 months after enrollment ]

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