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NCT Number: NCT06441617

Confirmatory Trial for Alleviating Fatigue in 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington VA Medical Center, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online Program for Fatigue

Device

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

Primary outcomes

  1. Chalder Fatigue Scale

    Time frame: Day 180

    The scale contains 11 items covering physical fatigue (items 1-7) and mental fatigue (items 8-11).

Secondary outcomes

  1. PROMIS FatigueMS-8a

    Time frame: Day 180

    The PROMIS FatigueMS-8a questionnaire has eight 5-point Likert scale items on different aspects of fatigue.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Grace Okafor

CONTACT

[email protected]

781-487-0008

Sponsors and collaborators

Lead sponsor

Accelerated Cure Project for Multiple Sclerosis

Other

Collaborators

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

Registry information

Acronym: CAFE-MS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2024
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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