An interventional study of Teleconference and Internet in Multiple Sclerosis, sponsored by Case Western Reserve University. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Case Western Reserve University · Not applicable, Interventional, and Treatment
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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 590 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Case Western Reserve University is the lead sponsor of 158 studies on the registry; 29 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
Teleconference Intervention arm
Behavioral: Teleconference
Internet Intervention arm
Behavioral: Internet
1-to-1, in-person or videoconference intervention arm
Behavioral: 1-to-1, in-person or videoconference
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.
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.
Unlike the teleconference and internet courses, the number and length of sessions for the 1-to-1, in-person or videoconference 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
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.
Time frame: Change from baseline to 6 months
Change From Baseline in Health-related Quality of Life: Psychological Composite
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.
Time frame: Change from baseline to 6 months
| Milestone | Teleconference | Internet | One-to-One |
|---|---|---|---|
| Started | 196 | 197 | 197 |
| Completed | 174 | 186 | 172 |
| Not completed | 22 | 11 | 25 |
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.
| score on a scale | Teleconference | Internet | One-to-one |
|---|---|---|---|
| Change From Baseline in Fatigue Levels | 50.98 ± 2.08 | 56.88 ± 0.59 | 57.87 ± 1.34 |
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.
| score on a scale | Teleconference | Internet | One-to-One |
|---|---|---|---|
| Change From Baseline in Health-related Quality of Life: Psychological Composite | 40.93 ± 23.05 | 38.66 ± 21.80 | 37.77 ± 21.68 |
Collected over Adverse event data was collected during the course of data collection for each participant, which was 6 months long.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Teleconference | 0/196 (0%) | 0/196 (0%) | 0/196 (0%) |
| Internet | 0/197 (0%) | 0/197 (0%) | 0/197 (0%) |
| One-to-One | 0/197 (0%) | 0/197 (0%) | 0/197 (0%) |
| Age, Continuous(years) | Teleconference | Internet | One-to-One | Total |
|---|---|---|---|---|
| Mean | 52 ± 11 | 53 ± 11 | 51 ± 12 | 52 ± 12 |
| Sex: Female, Male(Participants) | Teleconference | Internet | One-to-One | Total |
|---|---|---|---|---|
| Female | 166 | 158 | 161 | 485 |
| Male | 30 | 39 | 36 | 105 |
| Race/Ethnicity, Customized(Participants) | Teleconference | Internet | One-to-One | Total |
|---|---|---|---|---|
| Hispanic | 4 | 8 | 9 | 21 |
| Non-Hispanic | 191 | 188 | 187 | 566 |
| African American | 24 | 23 | 23 | 70 |
| Asian | 1 | 1 | 0 | 2 |
| White | 165 | 166 | 171 | 502 |
| American Indian/Alaska Native | 0 | 0 | 0 | 0 |
| Hawaiian/Pacific Islander | 0 | 0 | 0 | 0 |
| Multiracial | 6 | 3 | 3 | 12 |
| Missing Race | 0 | 4 | 0 | 4 |
| Fatigue Impact Scale(units on a scale) | Teleconference | Internet | One-to-One | Total |
|---|---|---|---|---|
| Mean | 68.62 ± 33.78 | 67.73 ± 33.03 | 68.10 ± 33.61 | 68.15 ± 33.42 |
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Case Western Reserve University