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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2,000
An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.
Washington VA Medical Center
Washington D.C., District of Columbia, United States
Baltimore VA Medical Center
Baltimore, Maryland, United States
iConquerMS
Waltham, Massachusetts, United States
Portland VA Medical Center
Portland, Oregon, United States
Nashville VA Medical Center
Nashville, Tennessee, United States
Seattle VA Medical Center
Seattle, Washington, United States
Chalder Fatigue Scale
The scale contains 11 items covering physical fatigue (items 1-7) and mental fatigue (items 8-11).
Time frame: Day 180
PROMIS FatigueMS-8a
The PROMIS FatigueMS-8a questionnaire has eight 5-point Likert scale items on different aspects of fatigue.
Time frame: Day 180
PROMIS MS Health
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.
Time frame: Day 180
SymptoMScreen
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.
Time frame: Day 180
Frenchay Activities Index
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.
Time frame: Day 180
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