Epilepsy Enhanced Care
Evaluating the Impact of Epilepsy Enhanced Care on Health Literacy in People With Epilepsy: A Nurse-led Educational Intervention Study
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Index group (newly diagnosed epilepsy + intervention)
Epilepsy Enhanced Care
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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.
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无干预：Control group 1 (newly diagnosed epilepsy, standard care only)
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无干预：Control group 2 (established epilepsy, standard care only, cross-sectional)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Improvement in health literacy
大体时间：From baseline to 3 months after enrollment
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Measured using Domain 2 ("Having sufficient information to manage my health") of the Health Literacy Questionnaire (HLQ).
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From baseline to 3 months after enrollment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in scores on other seven domains of the HLQ
大体时间：From baseline to 3 and 12 months after enrollment
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For each endpoint, the change in score from baseline to follow-up will be measured in the intervention groups, and scores will be compared between the intervention and control groups at follow-up
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From baseline to 3 and 12 months after enrollment
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Change in Epilepsy-specific knowledge score
大体时间：From baseline to 3 and 12 months after enrollment
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From baseline to 3 and 12 months after enrollment
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Change in Epilepsy Self-Management score
大体时间：From baseline to 3 and 12 months after enrollment
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From baseline to 3 and 12 months after enrollment
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Change in Generalized Anxiety Disorder 7 score
大体时间：From baseline to 3 and 12 months after enrollment
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From baseline to 3 and 12 months after enrollment
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Change in Neurological Disorders Depression Inventory for Epilepsy score
大体时间：From baseline to 3 and 12 months after enrollment
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From baseline to 3 and 12 months after enrollment
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Healthcare utilization
大体时间：From baseline to 3 and 12 months after enrollment
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Frequency of epilepsy-related emergency department visits, epilepsy-related hospitalizations, and unscheduled neurology consultations, collected through patient self-report and, where available, verified through electronic medical records.
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From baseline to 3 and 12 months after enrollment
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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Patient satisfaction score
大体时间：At 3 months after enrollment
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At 3 months after enrollment
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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