Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Accelerated Cure Project for Multiple Sclerosis
Study ID
NCT06441617
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Online Program for Fatigue — DEVICE
    An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.

Study Details

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.

Key Dates

Start date
Dec 5, 2024
Status verified
Apr 2026
Primary completion
Feb 15, 2027
Completion
Sep 14, 2027

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Chalder Fatigue Scale [ Time Frame: Day 180 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Washington VA Medical CenterWashington D.C.District of Columbia20422
Bryan Smith, MD
[email protected]
202-745-8000
Mitchell Wallin, MD, MPH
Bryan Smith, MD (PRINCIPAL_INVESTIGATOR)
Baltimore VA Medical CenterBaltimoreMaryland21201
Spencer Lin, BS
[email protected]
202-745-8146
Mitchell Wallin, MD, MPH (PRINCIPAL_INVESTIGATOR)
iConquerMSWalthamMassachusetts02451
Grace Okafor Clinical Trial Manager
[email protected]
781-487-0008
Stephanie Buxhoeveden, PhD, MSN, FNP-BC, MSCN (PRINCIPAL_INVESTIGATOR)
Portland VA Medical CenterPortlandOregon97239
Christopher Hollen, MD
[email protected]
503-220-8262
Carin Waslo, MPH
Christopher Hollen, MD (PRINCIPAL_INVESTIGATOR)
Nashville VA Medical CenterNashvilleTennessee37212
Jordon Winn
[email protected]
615-421-0590
Francesca Bagnato, MD, PhD (PRINCIPAL_INVESTIGATOR)
Seattle VA Medical CenterSeattleWashington98108
Reyhaneh Nikzad
[email protected]
206-277-3593
Aaron Turner, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Washington VA Medical Center· Washington D.C., DCBaltimore VA Medical Center· Baltimore, MDiConquerMS· Waltham, MAPortland VA Medical Center· Portland, ORNashville VA Medical Center· Nashville, TNSeattle VA Medical Center· Seattle, WA

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