Self-management for People With Epilepsy and a History of Negative Health Events (SMART)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Change in number of negative health events
研究概览
简要总结
This is an investigation of adult individuals with epilepsy, and involves educational and behavioral interventions intended to enhance treatment adherence and self-management.
The investigators are adapting a self-management intervention that they developed in a previous study to individuals with epilepsy and a history of negative health events (NHEs), such as accidents and emergency department (ED) visits, diminished quality of life and poor mental well-being. The intervention "Self-management for people with epilepsy and a history of negative health events (SMART)" is intended to reduce NHEs and improve quality of life in people with epilepsy associated with historically disadvantaged groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •Diagnosis of epilepsy
- •Negative health event within the last 6 months
- •Able to provide written consent and participate in study procedures
排除标准
- •Immediate risk of self-harm
- •Pregnancy
- •Unable to read/understand English
研究组 & 干预措施
SMART Intervention
Participants (a total of 120 individuals) will be randomly assigned to either SMART (N=60) or the wait-list control (N= 60), in a 1:1 ratio.
干预措施: self-management (Behavioral)
Wait-list
Participants assigned to the wait-list will start the SMART intervention 6 months following randomization.
干预措施: self-management (Behavioral)
结局指标
主要结局
Change in number of negative health events
时间窗: baseline, 6 months
次要结局
未报告次要终点
研究者
Martha Sajatovic, MD
Professor
Case Western Reserve University