Comparing the Effectiveness of Fatigue Management Programs for People With MS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Case Western Reserve University
- Enrollment
- 582
- Locations
- 3
- Primary Endpoint
- Change From Baseline in Fatigue Levels
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a multi-site randomized clinical trial comparing 3 modes of delivering the Managing Fatigue course for reducing fatigue in individuals with multiple sclerosis (MS). The primary hypothesis is that the teleconference and internet versions of the course will be noninferior to the one-on-one, in person version in terms of the primary outcome of fatigue and secondary outcome of quality of life.
Detailed Description
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 FDA has not approved medications for MS fatigue in the United States (US). However, there are empirically tested, non-pharmacological strategies that can support people with MS in reducing the impact of fatigue. Thus, the aim of the study is to compare 3 modes of delivering the Managing Fatigue course-2 telerehabilitation formats (teleconference and internet) and 1-to-1, in-person format (traditional mode of clinical service delivery)-upon outcomes important to people with MS, i.e., fatigue and its impact on physical, mental, and social function. The intervention arms will focus on reducing fatigue as a strategy to directly improve physical, mental and social functioning.
Investigators
Matthew Plow
Assistant Professor
Case Western Reserve University
Eligibility Criteria
Inclusion Criteria
- •Self-report diagnosis of MS
- •Age ≥ 18 years
- •Fatigue Severity Scale score ≥ 4
- •Ability to speak English
Exclusion Criteria
- •Individual must be capable of providing consent (Assessed with questionnaire)
- •Unable to access the internet or unable to travel to in-person sessions
Outcomes
Primary Outcomes
Change From Baseline in Fatigue Levels
Time Frame: Change from baseline to 6 months
Fatigue will be assessed with Fatigue Impact Scale. Fatigue Impact Scale is a 40-item questionnaire that measures impact of fatigue on day-to-day life. Scale ranges from "no problem" (0) to "extreme problem" (4). Total scores will be computed by summing responses for each item. Scores can range from 0 to 160 with a higher score indicating worse fatigue.
Secondary Outcomes
- Change From Baseline in Health-related Quality of Life: Psychological Composite(Change from baseline to 6 months)