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

April 10, 2026 updated by: Accelerated Cure Project for Multiple Sclerosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20422
        • Recruiting
        • Washington VA Medical Center
        • Contact:
        • Contact:
          • Mitchell Wallin, MD, MPH
        • Principal Investigator:
          • Bryan Smith, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Baltimore VA Medical Center
        • Contact:
        • Principal Investigator:
          • Mitchell Wallin, MD, MPH
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • Recruiting
        • iConquerMS
        • Contact:
        • Principal Investigator:
          • Stephanie Buxhoeveden, PhD, MSN, FNP-BC, MSCN
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Portland VA Medical Center
        • Contact:
        • Contact:
          • Carin Waslo, MPH
        • Principal Investigator:
          • Christopher Hollen, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Nashville VA Medical Center
        • Principal Investigator:
          • Francesca Bagnato, MD, PhD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98108
        • Recruiting
        • Seattle VA Medical Center
        • Principal Investigator:
          • Aaron Turner, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as Usual
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.
Device: Online Program for Fatigue
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.
Device: Online Program for Fatigue
An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chalder Fatigue Scale
Time Frame: Day 180
The scale contains 11 items covering physical fatigue (items 1-7) and mental fatigue (items 8-11).
Day 180

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS FatigueMS-8a
Time Frame: Day 180
The PROMIS FatigueMS-8a questionnaire has eight 5-point Likert scale items on different aspects of fatigue.
Day 180
PROMIS MS Health
Time Frame: Day 180
PROMIS MS Health has 14 domains, each comprising four 5-point Likert scale items, covering mobility limitations, spasticity, reduced hand and arm function, fatigue, pain, numbness, cognition issues, sleep disturbances, bowel and bladder dysfunction, vision problems, dizziness and vertigo, sexual dysfunction, mood and emotional changes plus a single 5-point Likert scale item for overall health.
Day 180
SymptoMScreen
Time Frame: Day 180
SymptoMScreen has twelve 7-point Likert scale items covering how each of the following MS symptoms affects everyday life activities: walking, hand function, spasticity, pain, sensory function, bladder control, fatigue, vision, dizziness, cognitive function, depression and anxiety.
Day 180
Frenchay Activities Index
Time Frame: Day 180
The Frenchay Activities Index (FAI) is a measure of instrumental activities of daily living (IADL) for use with patients with neurological disorders. The FAI assesses a broad range of activities associated with everyday life that the patient has participated in within the recent past, broken into 3 domains: domestic chores, leisure/work, and outdoor activities.
Day 180

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Acceptability
Time Frame: Day 180
The Treatment Acceptability questionnaire consists of seven 5-point Likert items covering affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy.
Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Accelerated Cure Project for Multiple Sclerosis

Collaborators

Charite University, Berlin, Germany
United States Department of Defense
US Department of Veterans Affairs
University Medical Center Goettingen
Congressionally Directed Medical Research Programs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2024

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

September 14, 2027

Study Registration Dates

First Submitted

May 29, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACP-CAFE-MS-001
  • CDMRP- MS220136 (Other Grant/Funding Number: Congressionally Directed Medical Research Programs (CDMRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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