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临床试验/NCT04240977
NCT04240977Unknown不适用

Feasibility and Single-arm Trial of HOBSCOTCH Telehealth Intervention in Refractory Epilepsy

Kessler Foundation1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年6月1日最近更新:
适应症
干预措施

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

Experimental

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)

研究者

发起方
Kessler Foundation
申办方类型
Other
责任方
Sponsor

研究点 (1)

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