Clinical trial NCT03550170: Fatigue Management Programs for People With MS
Official title: Comparing the Effectiveness of Fatigue Management Programs for People With MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Fatigue
Wellness
Multiple Sclerosis
Quality of life
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of Illinois at Chicago
name: University of Minnesota
name: Queen's University, Kingston, Ontario
name: Dalhousie University
name: The Cleveland Clinic
First posted: 2018-06-08
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Fatigue Levels
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Change From Baseline in Health-related Quality of Life: Psychological Composite
timeFrame: Change from baseline to 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Matthew Plow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Plow M, Packer T, Mathiowetz VG, Preissner K, Ghahari S, Sattar A, Bethoux F, Finlayson M. REFRESH protocol: a non-inferiority randomised clinical trial comparing internet and teleconference to in-person 'Managing Fatigue' interventions on the impact of fatigue among persons with multiple sclerosis. BMJ Open. 2020 Aug 16;10(8):e035470. doi: 10.1136/bmjopen-2019-035470.