Pilot Study of Real-time Automated Tracking System for Patients With Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
The investigators propose a novel method for tracking the seizure frequency, side effect burden, and medication compliance for patients with epilepsy. The investigators intend to utilize a table-top device currently for tracking other chronic disease to collect remote data from epilepsy patients. The hypothesis is that the use of this device will lead to better longterm treatment outcomes than the standard outpatient mechanism of following patients longitudinally.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Months 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants must have a definitive diagnosis of epilepsy for at least 6 months, based on the clinical judgement of the investigators. Epilepsy is defined by two or more unprovoked seizures. Clinical history, electroencephalography, and imaging data are all instrumental in rendering a formal decision. The seizure type, frequency, or severity are not criteria for exclusion, although this information will be recorded.
- •Patient can range in age from birth to 65 years old; in cases of child participants, the parents are responsible for data reporting.
- •Patients must have a seizure frequency of at least two seizures in a 6 month period of time.
- •Patients must be on at least one anti-epileptic medication.
- •Patients and/or legal guardian must be able to report seizure frequency with either a paper or electronic diary.
- •Patients and/or legal guardians must be able to read and understand either English or Spanish.
- •Patients and/or legal guardians must be able to complete questionnaires and provide informed consent to this study.
排除标准
- •Exclusion criteria include: a diagnosis of psychogenic nonepileptic seizures; severe depression, anxiety, or psychosis
- •Recent problem with substance abuse.
结局指标
主要结局
Quality of life
时间窗: 1 year
Quality of Life in Epilepsy inventory, to assess for overall change in quality of life measures
Seizure frequency per month
时间窗: 1 year
Assessment of seizure count accuracy by assessing total number of seizures reported per month
Medication compliance
时间窗: 1 year
Assessment of compliance with taking medications at regularly scheduled intervals
次要结局
未报告次要终点
研究者
John Hixson
Associate Professor of Neurology
University of California, San Francisco