Clinical trial NCT06441617: Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
Official title: Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Multiple Sclerosis
Fatigue
Lead sponsor: Accelerated Cure Project for Multiple Sclerosis
Sponsor class: OTHER
Collaborators: name: Congressionally Directed Medical Research Programs
name: United States Department of Defense
name: Charite University, Berlin, Germany
name: University Medical Center Goettingen
name: US Department of Veterans Affairs
First posted: 2024-06-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Chalder Fatigue Scale
timeFrame: Day 180
Secondary outcomes:
measure: PROMIS FatigueMS-8a
timeFrame: Day 180
measure: PROMIS MS Health
timeFrame: Day 180
measure: SymptoMScreen
timeFrame: Day 180
measure: Frenchay Activities Index
timeFrame: Day 180
Other outcomes:
measure: Treatment Acceptability
timeFrame: Day 180
Locations:
city: Washington
country: United States
facility: Washington VA Medical Center
state: District of Columbia
city: Baltimore
country: United States
facility: Baltimore VA Medical Center
state: Maryland
city: Waltham
country: United States
facility: iConquerMS
state: Massachusetts
city: Portland
country: United States
facility: Portland Va Medical Center
state: Oregon
Study officials:
References: