HOBSCOTCH Phase III: Efficacy of Enhanced Virtual HOBSCOTCH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 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 efficacy of an entirely virtual version of the home-based cognitive self-management program "HOBSCOTCH." It will test whether HOBSCOTCH can be delivered nationally from a distance utilizing e-health tools (telephone, computer, and phone).
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 III is a study to examine an entirely virtual version of the program. While HOBSCOTCH was shown to be effective as an in-person and telephone-based program in previous trials (HOBSCOTCH Phase I and II), this study aims to test a version of the program adapted for entirely virtual delivery. This is a single-center study, with the HOBSCOTCH intervention being delivered by staff affiliated with Dartmouth-Hitchcock Medical Center in Lebanon, NH.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Internet access
排除标准
- •Subjects self-reporting a dementing illness or a mention of a dementing illness in their medical record
- •Severe mental disability or estimated IQ less than 70 per clinical judgement
- •Significant visual impairment precluding reading or writing
- •No reliable telephone or internet access
- •No diagnosis of epilepsy
研究组 & 干预措施
HOBSCOTCH-V (virtual)
Participants will receive the HOBSCOTCH intervention consisting of 1:1 sessions delivered once per week, including:
- 1 pre-HOBSCOTCH Session (on webcam)
- 1 educational session (on webcam)
- 6 telephone sessions
- 1 wrap-up session (webcam or telephone)
Participants will also receive 3 booster sessions, via webcam or telephone, once per month.
干预措施: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH) (Behavioral)
Control
Participants will be wait listed and will receive HOBSCOTCH-V (above) following a 6 month wait period.
干预措施: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH) (Behavioral)
结局指标
主要结局
Change in quality of life
时间窗: Baseline and at months 3, 6, 9, 12
The researchers will use the 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. Scores range from 0 to 100, with a higher score reflecting a higher quality of life.
Change in cognitive function
时间窗: Baseline and at months 3, 6, 9, 12
The researchers will use the Cognitive Function sub-scale of the NeuroQOL. This is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.
次要结局
- Changes in self-reported seizure frequency(Ongoing through entire study baseline - 12 months)
- Changes in medication adherence(Ongoing through entire study baseline - 12 months, and at baseline and at months 3, 6, 9, 12)
- Changes in overall well-being(Ongoing through entire study baseline - 12 months)
- Change in self-management practices(Baseline and at months 3, 6, 9, 12)
- Change in depression(Baseline and at months 3, 6, 9, 12)
- Changes in health confidence(Baseline and at months 3, 6, 9, 12)
- Changes in healthcare utilization(Baseline and at months 3, 6, 9, 12)
研究者
Barbara Jobst
Staff Physician, Neurology
Dartmouth-Hitchcock Medical Center