Fatigue Management Programs for People With MS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparing the Effectiveness of Fatigue Management Programs for People With MS

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Teleconference
* Behavioral: Internet
* Behavioral: 1-to-1, in-person


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Teleconference<br>Teleconference Intervention arm | Behavioral: Teleconference<br>* 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.<br>|
| Active Comparator: Internet<br>Internet Intervention arm | Behavioral: Internet<br>* 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.<br>|
| Active Comparator: I-to-1, in-person<br>1-to-1, in-person intervention arm | Behavioral: 1-to-1, in-person<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in fatigue levels | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Wellness, Multiple Sclerosis, Quality of life