Fatigue Management Programs for People With MS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03550170|
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : December 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Behavioral: Teleconference Behavioral: Internet Behavioral: 1-to-1, in-person||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||582 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Teleconference
Teleconference Intervention arm
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
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.
- 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.
- 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.
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
|Contact: Matthew Plow, PhD||(216)email@example.com|
|United States, Illinois|
|University of Illinois at Chicago||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Kathy Preissner, EdD firstname.lastname@example.org|
|Sub-Investigator: Kathy Preissner, EdD|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Virgil Mathiowetz, PhD email@example.com|
|Sub-Investigator: Virgil Mathiowetz, PhD|
|United States, Ohio|
|Case Western Reserve University||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Matthew Plow, PhD firstname.lastname@example.org|
|Principal Investigator: Matthew Plow, PhD|
|Principal Investigator:||Matthew Plow, PhD||Case Western Reserve University|