Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Online Program for Fatigue.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Fatigue. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Online Program for Fatigue
An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.
Primary outcome measures
- Chalder Fatigue Scale [Time frame: Day 180]
Secondary outcome measures (4)
- PROMIS FatigueMS-8a [Time frame: Day 180]
- PROMIS MS Health [Time frame: Day 180]
- SymptoMScreen [Time frame: Day 180]
- Frenchay Activities Index [Time frame: Day 180]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- Washington VA Medical Center — Washington D.C.
- Baltimore VA Medical Center — Baltimore
- iConquerMS — Waltham
- Portland VA Medical Center — Portland
- Nashville VA Medical Center — Nashville
- Seattle VA Medical Center — Seattle
Identifiers
NCT: NCT06441617 · ACP-CAFE-MS-001 · CDMRP- MS220136