Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis (CAFE-MS)

Accelerated Cure Project for Multiple Sclerosis

Status: Invitation-only

Conditions: Multiple Sclerosis; Fatigue

Treatments: Device: Online Program for Fatigue

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06441617

ACP-CAFE-MS-001

CDMRP- MS220136 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,000 participants in 3 patient groups

Fatigue Program A added to Treatment as Usual

Experimental group

Description:

An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.

Treatment:

Device: Online Program for Fatigue

Fatigue Program B added to Treatment as Usual

Active Comparator group

Description:

Fatigue Program B will use a web-based interface with similar design and functionality as Fatigue Program A.

Treatment:

Device: Online Program for Fatigue

Treatment as Usual

No Intervention group