HOBSCOTCH Phase II: A Pragmatic Study of HOBSCOTCH in New England.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 8
- 主要终点
- Change in Quality of Life
研究概览
简要总结
The purpose of this study is to determine the feasibility and efficacy of the home-based cognitive self-management program "HOBSCOTCH" delivered at four New England medical centers. It will test the long-term impact and cost-effectiveness of HOBSCOTCH, and whether it can be delivered from a distance utilizing e-health tools for parts of the program.
详细描述
HOBSCOTCH (Home Based Self-management and Cognitive Training Changes lives) is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life.
HOBSCOTCH Phase II is a replication study of the original HOBSCOTCH study, designed to translate the findings of HOBSCOTCH into a real world setting. This is a multi-center study, with the HOBSCOTCH intervention being implemented at four epilepsy clinics in New England.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70
- •Confirmed diagnosis of epilepsy, with controlled or uncontrolled seizures
- •Subjective memory complaints
- •No changes in antiepileptic and antidepressant medication regimen for 1 month, however brief discontinuation of antiepileptic medicine for inpatient video EEG evaluation is acceptable
- •Telephone access
排除标准
- •Subjects age 66-70 with a mention of a dementing illness in their medical record
- •Severe mental disability or estimated IQ less than 70
- •Significant visual impairment precluding reading or writing
- •No reliable telephone access
结局指标
主要结局
Change in Quality of Life
时间窗: Baseline and months: 3, 6, 9, 12, 15
We will be using Quality of Life in Epilepsy (QOLIE-31). This validated tool contains 16 multi-item scales which assess health related quality of life, emotional well-being, memory and attention deficits, medication effects, seizure control, psychosocial functioning, and health perception
Change in Healthcare Utilization
时间窗: Baseline and months: 3, 6, 9, 12, 15
We will be using the Healthcare Utilization in Epilepsy (HCU-E). This validated survey is concordant with billing data. It assesses seizure frequency and whether the subject had received any of the following services because of their epilepsy over the past 3 months: hospital ER services, general practice or family doctor visits, neurologist or epilepsy specialist visits, and overnight hospital inpatient stay.
次要结局
- Change in Depression(Baseline and months: 3, 6, 9, 12, 15)
- Change in Cognition(Baseline and months: 3, 6, 9, 12, 15)
- Change in Self-Management Practices(Baseline and months: 3, 6, 9, 12, 15)
- Change in Cognitive Function(Baseline and months: 3, 6, 9, 12, 15)
研究者
Barbara Jobst
Staff Physician, Neurology
Dartmouth-Hitchcock Medical Center