Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
Purpose
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.
Conditions
- Multiple Sclerosis
- Fatigue
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Informed consent by person with MS - Living in the US - Age ≥ 22 - 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)
Exclusion Criteria
- Unwilling or unable to consent - Refusal to saving, processing and forwarding of pseudonymized data - Concurrent participation in another interventional trial
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
- Masking Description
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Active Comparator 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. |
|
|
No Intervention Treatment as Usual |
|
Recruiting Locations
Washington D.C. 4140963, District of Columbia 4138106 20422
Baltimore 4347778, Maryland 4361885 21201
More Details
- Status
- Recruiting
- Sponsor
- Accelerated Cure Project for Multiple Sclerosis