Feasibility and Single-arm Trial of HOBSCOTCH Telehealth Intervention in Refractory Epilepsy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Quality of Life in Epilepsy - 31 score
研究概览
简要总结
The purpose of this study is to see whether a phone-intervention called HOBSCOTCH will improve health, daily functioning and quality of life among patients with refractory epilepsy. HOBSCOTCH stands for "Home-Based Self-Management and Cognitive Training Changes Lives." This study will also help to find the best ways of integrating this telehealth intervention to routine clinic use.
详细描述
The proposed project will assess the efficacy of an 8-week phone-delivered, experimental treatment called "Home-Based Self-Management and Cognitive Training Changes Lives" (HOBSCOTCH) on sixty patients with refractory epilepsy (PWRE). The investigators will employ a prospective, single blind randomized clinical trial design with wait-list controls to examine both objective and subjective measures of daily life, daily functioning, cognition, and emotional well-being. Investigators will also assess the impact of HOBSCOTCH on employment and work productivity using the Lam Employment absence and Disability Scale (LEAPS) and the Sheehan Disability Scale (SDS). Lastly, the investigators will examine whether changes in these domains are maintained three months after completion of the intervention. The study will expand the efficacy literature for HOBSCOTCH and further refine its use in a busy clinical environment, and therefore has potential to benefit the patient population (PWRE), who currently lacks treatment options besides the pharmacological and surgical care currently available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is able to read and speak English.
- •Patient has a reliable telephone connection and a private place they can use during the course of this study
- •They do not have any treatment or intervention plan in place for the next 6 months. They may be on an anti-epileptic drug regimen that has not been changed in the past 3 months.
排除标准
- 未提供
研究组 & 干预措施
Treatment Group
干预措施: HOBSCOTCH: "Home-Based Self-Management and Cognitive Training Changes Lives" (Behavioral)
结局指标
主要结局
Change in Quality of Life in Epilepsy - 31 score
时间窗: baseline & 8-10 weeks after baseline
overall raw score \[15-97\] that corresponds to reported levels of worry, emotional well-being, energy/fatigue, cognitive functioning, medication effects and social functioning
次要结局
- Feasibility of HOBSCOTCH in the clinical setting(baseline)
