Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
- Conditions
- Multiple SclerosisFatigue
- Interventions
- Device: Online Therapy for Fatigue
- Registration Number
- NCT06441617
- Lead Sponsor
- Accelerated Cure Project for Multiple Sclerosis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 2000
- 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)
- Unwilling or unable to consent
- Refusal to saving, processing and forwarding of pseudonymized data
- Concurrent participation in another interventional trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fatigue Program A added to Treatment as Usual Online Therapy for Fatigue An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser. Fatigue Program B added to Treatment as Usual Online Therapy for Fatigue Fatigue Program B will use a web-based interface with similar design and functionality as Fatigue Program A.
- Primary Outcome Measures
Name Time Method Chalder Fatigue Scale Day 180 The scale contains 11 items covering physical fatigue (items 1-7) and mental fatigue (items 8-11).
- Secondary Outcome Measures
Name Time Method PROMIS MS Health 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.
SymptoMScreen 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.
Frenchay Activities Index 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.
PROMIS FatigueMS-8a Day 180 The PROMIS FatigueMS-8a questionnaire has eight 5-point Likert scale items on different aspects of fatigue.
Trial Locations
- Locations (4)
Washington VA Medical Center
🇺🇸Washington, District of Columbia, United States
Portland Va Medical Center
🇺🇸Portland, Oregon, United States
Baltimore VA Medical Center
🇺🇸Baltimore, Maryland, United States
iConquerMS
🇺🇸Waltham, Massachusetts, United States