Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,000
- 试验地点
- 6
- 主要终点
- Chalder Fatigue Scale
研究概览
简要总结
CAFE-MS will assess the effectiveness of two online programs for fatigue in multiple sclerosis (MS). Although they differ, both of these online programs contain information about MS and fatigue intended to help people with MS understand and manage their fatigue.
This large-scale, decentralized clinical trial is projected to enroll 2,000 people with MS. The collaboration between iConquerMS and 5 Veterans Affairs (VA) sites in the MS Centers of Excellence is designed to ensure sufficient representation of people with MS from populations traditionally under-represented in MS clinical trials.
The study is a 3-arm, randomized controlled clinical trial with study participation lasting 1 year. Two of the trial arms will include one of two online programs for managing fatigue in MS added to the trial participants' usual MS treatment, and the third arm will include usual MS treatment alone. The online program phase of the trial lasts for 6 months after randomization followed by a final study visit at 12 months. Participants in the usual MS treatment alone arm for the first 6 months will have an opportunity to choose one of the online programs for the final 6 months of the trial.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded with respect to Program A and Program B. However, the third arm of the trial, Treatment as Usual, will not be blinded. Since outcome assessments are collected online via surveys, the outcome assessor is a blinded entity.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent by person with MS
- •Living in the US
- •Confirmed diagnosis of MS by a physician, who is a neurologist or has access to a neurologist's statement of diagnosis
- •Fatigue Severity Scale score at or above eligibility threshold
- •Fluent in English
- •Willingness to engage in self-administration of an online intervention for 24 weeks and complete follow-up assessments
- •Access to the internet and e-mail with a compatible device (smartphone, computer, or tablet)
- •No MS relapse / no steroid treatment in the 4 weeks prior to answering the screening questionnaire (self-reported)
- •No disease-modifying therapeutic (DMT) started in the 4 weeks prior to answering the screening questionnaire (self-reported)
排除标准
- •Unwilling or unable to consent
- •Refusal to saving, processing and forwarding of pseudonymized data
- •Concurrent participation in another interventional trial
研究组 & 干预措施
Fatigue Program B added to Treatment as Usual
Fatigue Program B will use a web-based interface with similar design and functionality as Fatigue Program A.
干预措施: Online Program for Fatigue (Device)
Fatigue Program A added to Treatment as Usual
An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.
干预措施: Online Program for Fatigue (Device)
Treatment as Usual
结局指标
主要结局
Chalder Fatigue Scale
时间窗: Day 180
The scale contains 11 items covering physical fatigue (items 1-7) and mental fatigue (items 8-11).
次要结局
- PROMIS MS Health(Day 180)
- SymptoMScreen(Day 180)
- Frenchay Activities Index(Day 180)
- PROMIS FatigueMS-8a(Day 180)