Epilepsy Enhanced Care

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Improvement in health literacy [Срок оценки: From baseline to 3 months after enrollment]

Вторичные конечные точки (6)

• Changes in scores on other seven domains of the HLQ [Срок оценки: From baseline to 3 and 12 months after enrollment]
• Change in Epilepsy-specific knowledge score [Срок оценки: From baseline to 3 and 12 months after enrollment]
• Change in Epilepsy Self-Management score [Срок оценки: From baseline to 3 and 12 months after enrollment]
• Change in Generalized Anxiety Disorder 7 score [Срок оценки: From baseline to 3 and 12 months after enrollment]
• Change in Neurological Disorders Depression Inventory for Epilepsy score [Срок оценки: From baseline to 3 and 12 months after enrollment]
• Healthcare utilization [Срок оценки: From baseline to 3 and 12 months after enrollment]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07709481 · CE5171

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗