Fatigue, Multiple Sclerosis
Conditions
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.
Interventions
DEVICEOnline Program for Fatigue
An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.
Sponsors
Accelerated Cure Project for Multiple Sclerosis
Congressionally Directed Medical Research Programs
United States Department of Defense
Charite University, Berlin, Germany
University Medical Center Goettingen
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be blinded with respect to Program A and Program B. However, the third arm of the trial, Treatment as Usual, will not be blinded. Since outcome assessments are collected online via surveys, the outcome assessor is a blinded entity.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chalder Fatigue Scale | Day 180 | The scale contains 11 items covering physical fatigue (items 1-7) and mental fatigue (items 8-11). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| PROMIS FatigueMS-8a | Day 180 | The PROMIS FatigueMS-8a questionnaire has eight 5-point Likert scale items on different aspects of fatigue. |
| 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. |
Countries
United States
Outcome results
None listed