NCT07709481Toborzás még nem indult
Epilepsy Enhanced Care
Evaluating the Impact of Epilepsy Enhanced Care on Health Literacy in People With Epilepsy: A Nurse-led Educational Intervention Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 16.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 166 (tervezett)
- Első benyújtás
- 2026. júl. 12.
- Kezdés
- 2026. aug.
- Elsődleges befejezés
- 2028. aug.
- Fő szponzor
- Ente Ospedaliero Cantonale, Bellinzona
- Betegségek
- Epilepszia
- NCT-szám
- NCT07709481
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 166
- 2026. aug. és az elsődleges befejezés (2028. aug.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Previous participation in a structured epilepsy education program;
Egyéb
- Severe untreated comorbidities precluding attendance.
Kiket keres a vizsgálat
- Age ≥18 years;
- Confirmed epilepsy diagnosis (ILAE criteria);
- Ability to provide informed consent (or legal representative);
- Sufficient Italian proficiency.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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