Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). MS fatigue can impact all aspects of quality of life, including physical, mental, and social function. MS fatigue is a profound barrier to participating in meaningful activities, such as employment and hobbies. Currently, the Food and Drug Administration has not approved drugs for MS fatigue in the United States. However, there are empirically tested, nonpharmacological strategies that can support people with MS in reducing the impact of fatigue. In fact, meta-analyses show that fatigue self-management courses may be more effective than medications in reducing fatigue. Research indicates that a fatigue self-management course called Managing Fatigue is effective in reducing the impact of fatigue in a variety of different delivery formats. Participants in the course learn about taking rest breaks, re-evaluating priorities, communicating needs, re-organizing spaces, and experimenting with strategies for “banking” energy and “spending” limited energy to meet personal, meaningful goals.
The purpose of this study is to compare the effect of three modes of delivering the Managing Fatigue course—two telerehabilitation formats (teleconference or internet) and one traditional format (one-on-one, in person) used in clinical practice—on outcomes important to people with MS (i.e., fatigue and its impact on physical, mental, and social function). To accomplish this purpose, we will conduct a multicentered randomized clinical trial using a pragmatic design among 610 participants with MS. Participants will be randomized to teleconference, internet, or in-person versions of the course led by a licensed occupational therapist.
We hypothesize that teleconference and internet versions of the course will be noninferior to the traditional mode of clinical service delivery (i.e., one-on-one, in person) in terms of the primary outcome of fatigue and secondary outcome of quality of life. With a finding of noninferiority, the more easily accessible teleconference and internet versions of the course can be recommended in lieu of the traditional mode of clinical service delivery. Results from this proposal could be used as rationale to deliver telerehabilitation versions of the Managing Fatigue course to people who typically cannot access these courses due to geographic barriers. Furthermore, people with MS will be able to confidently conclude that they can participate in telerehabilitation formats to reduce the impact of fatigue. Recruitment efforts will focus on the inclusion of underserved population segments, including people with physical and mental disabilities, people who are diverse in race and ethnicity, and people who live in rural areas. The diversity of the proposed research sample will facilitate analyses that help determine whether the course is effective across different subgroups or whether disease, demographic, and/or psychosocial characteristics should be used to further tailor fatigue self-management courses.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.