Fatigue Management Programs for People With MS

December 16, 2021 updated by: Matthew Plow, Case Western Reserve University

Comparing the Effectiveness of Fatigue Management Programs for People With MS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

582

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Matthew Plow, PhD
  • Phone Number: (216)3688969
  • Email: map208@case.edu

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois at Chicago
        • Contact:
        • Sub-Investigator:
          • Kathy Preissner, EdD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Sub-Investigator:
          • Virgil Mathiowetz, PhD
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University
        • Contact:
        • Principal Investigator:
          • Matthew Plow, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Teleconference
Teleconference Intervention arm
Behavioral: Teleconference
This intervention arm will be a 6-week, group-based course involving weekly 80-min teleconference sessions. It will be delivered in small groups (6-12 participants) to maximize participants' opportunities for interaction. A program manual divided into 6 sections, 1 for each week that includes worksheets and homework activities will be given to the participants. Occupational therapists will facilitate the sessions. Participants and the OT will dial into 1-800 conference call line on the designated date and time.
Active Comparator: Internet
Internet Intervention arm
Behavioral: Internet
The internet course is similar to the teleconference format. It will occur in a 6-week period and be group based; i.e., 8-12 participants will begin the intervention at the same time and interact with each other during the 6-week period. Participants will be given a username and a password to view a different session each week at a time convenient for them. Each session will include completing practice activities and sharing information (e.g., offering advice and support to one another through the discussion forum). OTs will facilitate the discussions by responding to entries, asking questions, and providing encouragement to complete sessions.
Active Comparator: I-to-1, in-person
1-to-1, in-person intervention arm
Behavioral: 1-to-1, in-person
Unlike the teleconference and internet courses, the number and length of sessions for the 1-to-1, in-person course will vary over the 6-week period. The OT will cover all 6 topics, but the pace will be tailored to the participants' needs and preferences. Thus, although the topics are consistent, OTs are able to spend more time on topics that participants find pertinent to their situations. The participant and OT will be instructed to meet at least 3 times with at least 7 days between each session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in fatigue levels
Time Frame: Each patient will be given the assessments at 4 points during the study, at baseline, 8 weeks, 3 months, and 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.
Each patient will be given the assessments at 4 points during the study, at baseline, 8 weeks, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in quality of life will be assessed
Time Frame: Each patient will be given the assessments at 4 points during the study, at baseline, 8 weeks, 3 months, and 6 months

Multiple Sclerosis Impact Scale and Community Participation Indicators will be used.

Multiple Sclerosis Impact Scale is considered measure of health-related quality of life. It consists of 29 self-report questions that includes 2 subscales: physical function and mental function.

Community Participation Indicators consists of 20 questions about various social activities and community roles. Participants are asked to rate their frequency of engagement, whether it was important, and whether they were doing it enough.
Each patient will be given the assessments at 4 points during the study, at baseline, 8 weeks, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Collaborators

Patient-Centered Outcomes Research Institute
The Cleveland Clinic
University of Illinois at Chicago
University of Minnesota
Dalhousie University
Queen's University, Kingston, Ontario

Investigators

  • Principal Investigator: Matthew Plow, PhD, Case Western Reserve University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Anticipated)

February 28, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

May 24, 2018

First Submitted That Met QC Criteria

June 6, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

December 17, 2021

Last Update Submitted That Met QC Criteria

December 16, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-1610-37015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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