Epilepsy Enhanced Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Epilepsy Enhanced Care.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating the Impact of Epilepsy Enhanced Care on Health Literacy in People With Epilepsy: A Nurse-led Educational Intervention Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Improvement in health literacy [Time frame: From baseline to 3 months after enrollment]
Secondary outcome measures (6)
- Changes in scores on other seven domains of the HLQ [Time frame: From baseline to 3 and 12 months after enrollment]
- Change in Epilepsy-specific knowledge score [Time frame: From baseline to 3 and 12 months after enrollment]
- Change in Epilepsy Self-Management score [Time frame: From baseline to 3 and 12 months after enrollment]
- Change in Generalized Anxiety Disorder 7 score [Time frame: From baseline to 3 and 12 months after enrollment]
- Change in Neurological Disorders Depression Inventory for Epilepsy score [Time frame: From baseline to 3 and 12 months after enrollment]
- Healthcare utilization [Time frame: From baseline to 3 and 12 months after enrollment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07709481 · CE5171