Fatigue Management Programs for People With MS

Case Western Reserve University

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: 1-to-1, in-person or videoconference; Behavioral: Internet; Behavioral: Teleconference

Study type: Interventional

Funder types: Other

Identifiers

NCT03550170

MS-1610-37015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 590 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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590 participants in 3 patient groups

Teleconference

Active Comparator group

Description:

Teleconference Intervention arm

Treatment:

Behavioral: Teleconference

Internet

Active Comparator group

Description:

Internet Intervention arm

Treatment:

Behavioral: Internet

I-to-1, in-person or videoconference

Active Comparator group

Description:

1-to-1, in-person or videoconference intervention arm

Treatment:

Behavioral: 1-to-1, in-person or videoconference