Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis

Launched by ACCELERATED CURE PROJECT FOR MULTIPLE SCLEROSIS · May 29, 2024

Keywords

ClinConnect Summary

CAFE-MS is a large, three-arm clinical trial testing whether two online fatigue-management programs added to people’s usual MS care can reduce fatigue and improve daily living, compared with usual MS care alone. Participants are randomly assigned to one of three groups: Fatigue Program A plus usual care, Fatigue Program B plus usual care, or usual care by itself. The main goal is to measure fatigue levels about 6 months after starting, using the Chalder Fatigue Scale, with additional checks on how acceptable the programs are and how they affect overall well-being and daily functioning.

Eligible participants are adults 22 years and older with relapsing or progressive MS living in the United States, who have internet access and fluent English, and who have fatigue that meets the study threshold. They must be willing to use an online program for 24 weeks and complete follow-up assessments, and must not have had an MS relapse or started a new MS treatment in the prior 4 weeks. The trial aims to enroll about 2,000 people across multiple VA centers and partner sites, and participation lasts about one year (the online programs run for 6 months; those in the usual-care arm can choose an online program after 6 months). Results are not yet available since the study is still ongoing.

Gender

ALL

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