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Fatigue Management Programs for People With MS

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ClinicalTrials.gov Identifier: NCT03550170
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : December 17, 2021
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
University of Illinois at Chicago
University of Minnesota
Queen's University, Kingston, Ontario
Dalhousie University
The Cleveland Clinic
Information provided by (Responsible Party):
Matthew Plow, 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Teleconference Behavioral: Internet Behavioral: 1-to-1, in-person Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 582 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing the Effectiveness of Fatigue Management Programs for People With MS
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550170


Contacts
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Contact: Matthew Plow, PhD (216)3688969 map208@case.edu

Locations
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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Kathy Preissner, EdD       kpreiss@uic.edu   
Sub-Investigator: Kathy Preissner, EdD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Virgil Mathiowetz, PhD       mathi003@umn.edu   
Sub-Investigator: Virgil Mathiowetz, PhD         
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Matthew Plow, PhD       map208@case.edu   
Principal Investigator: Matthew Plow, PhD         
Sponsors and Collaborators
Case Western Reserve University
Patient-Centered Outcomes Research Institute
University of Illinois at Chicago
University of Minnesota
Queen's University, Kingston, Ontario
Dalhousie University
The Cleveland Clinic
Investigators
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Principal Investigator: Matthew Plow, PhD Case Western Reserve University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matthew Plow, Assistant Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT03550170    
Other Study ID Numbers: MS-1610-37015
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthew Plow, Case Western Reserve University:
Fatigue
Wellness
Multiple Sclerosis
Quality of life
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases