Fatigue Management Programs for People With MS

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Teleconference; Behavioral: Internet; Behavioral: 1-to-1, in-person or videoconference

• Registration Number: NCT03550170
• Lead Sponsor: Case Western Reserve University

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.

Study Timeline

• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-06-06
• Study First Posted: 2018-06-08
• Study Start: 2019-03-01
• Primary Completion: 2023-04-28
• Study Completion: 2023-04-28
• Results First Submitted: 2023-10-18
• Results First Submitted QC: 2024-05-24
• Results First Posted: 2024-09-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 582

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teleconference	Teleconference	Teleconference Intervention arm
Internet	Internet	Internet Intervention arm
I-to-1, in-person or videoconference	1-to-1, in-person or videoconference	1-to-1, in-person or videoconference intervention arm

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Fatigue Levels	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 Outcome Measures

Name	Time	Method
Change From Baseline in Health-related Quality of Life: Psychological Composite	Change from baseline to 6 months	Multiple Sclerosis Impact Scale (MSIS) was used to measure health-related quality of life. It consists of 29 self-report questions. The psychological composite score is calculated on a scale between 1 and 100. Higher scores indicate worse health-related quality of life.

Trial Locations

Locations (3)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States