Comparing the Effectiveness of Fatigue Management Programs for People With MS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 590
- 试验地点
- 3
- 主要终点
- Change From Baseline in Fatigue Levels
研究概览
简要总结
This is a multi-site randomized clinical trial comparing 3 modes of delivering the Managing Fatigue course for reducing fatigue in individuals with multiple sclerosis (MS). The primary hypothesis is that the teleconference and internet versions of the course will be noninferior to the one-on-one, in person version in terms of the primary outcome of fatigue and secondary outcome of quality of life.
详细描述
Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). MS fatigue can impact all aspects of quality of life, including physical, mental, and social function. MS fatigue is a profound barrier to participating in meaningful activities, such as employment and hobbies. Currently, the FDA has not approved medications for MS fatigue in the United States (US). However, there are empirically tested, non-pharmacological strategies that can support people with MS in reducing the impact of fatigue. Thus, the aim of the study is to compare 3 modes of delivering the Managing Fatigue course-2 telerehabilitation formats (teleconference and internet) and 1-to-1, in-person format (traditional mode of clinical service delivery)-upon outcomes important to people with MS, i.e., fatigue and its impact on physical, mental, and social function. The intervention arms will focus on reducing fatigue as a strategy to directly improve physical, mental and social functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Self-report diagnosis of MS
- •Age ≥ 18 years
- •Fatigue Severity Scale score ≥ 4
- •Ability to speak English
排除标准
- •Individual must be capable of providing consent (Assessed with questionnaire)
- •Unable to access the internet or unable to travel to in-person sessions
研究组 & 干预措施
Teleconference
Teleconference Intervention arm
干预措施: Teleconference (Behavioral)
Internet
Internet Intervention arm
干预措施: Internet (Behavioral)
I-to-1, in-person or videoconference
1-to-1, in-person or videoconference intervention arm
干预措施: 1-to-1, in-person or videoconference (Behavioral)
结局指标
主要结局
Change From Baseline in Fatigue Levels
时间窗: Change from baseline to 6 months
Fatigue will be assessed with Fatigue Impact Scale. Fatigue Impact Scale is a 40-item questionnaire that measures impact of fatigue on day-to-day life. Scale ranges from "no problem" (0) to "extreme problem" (4). Total scores will be computed by summing responses for each item. Scores can range from 0 to 160 with a higher score indicating worse fatigue.
次要结局
- Change From Baseline in Health-related Quality of Life: Psychological Composite(Change from baseline to 6 months)
研究者
Matthew Plow
Assistant Professor
Case Western Reserve University