Evaluating the Impact of Epilepsy Enhanced Care on Health Literacy in People With Epilepsy: A Nurse-led Educational Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 166
- 主要终点
- Improvement in health literacy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Confirmed epilepsy diagnosis (ILAE criteria);
- •Ability to provide informed consent (or legal representative);
- •Sufficient Italian proficiency.
排除标准
- •Previous participation in a structured epilepsy education program;
- •Severe untreated comorbidities precluding attendance.
结局指标
主要结局
Improvement in health literacy
时间窗: From baseline to 3 months after enrollment
Measured using Domain 2 ("Having sufficient information to manage my health") of the Health Literacy Questionnaire (HLQ).
次要结局
- Change in Epilepsy Self-Management score(From baseline to 3 and 12 months after enrollment)
- Change in Generalized Anxiety Disorder 7 score(From baseline to 3 and 12 months after enrollment)
- Change in Neurological Disorders Depression Inventory for Epilepsy score(From baseline to 3 and 12 months after enrollment)
- Changes in scores on other seven domains of the HLQ(From baseline to 3 and 12 months after enrollment)
- Change in Epilepsy-specific knowledge score(From baseline to 3 and 12 months after enrollment)
- Healthcare utilization(From baseline to 3 and 12 months after enrollment)
研究者
Payam Tabaee Damavandi
Dr. med.
Ente Ospedaliero Cantonale, Bellinzona