Multiple Sclerosis
Conditions
Keywords
Fatigue, Wellness, Multiple Sclerosis, Quality of life
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.
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.
Interventions
BEHAVIORALTeleconference
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.
BEHAVIORALInternet
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.
BEHAVIORAL1-to-1, in-person or videoconference
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.
Sponsors
Patient-Centered Outcomes Research Institute
University of Illinois at Chicago
University of Minnesota
Queen's University, Kingston, Ontario
Dalhousie University
The Cleveland Clinic
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fatigue Levels | Change from baseline to 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 with a higher score indicating worse fatigue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Health-related Quality of Life: Psychological Composite | Change from baseline to 6 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
Enrolled participants would only be excluded from the study before assignment to groups if they did not meet the inclusion criteria stated in the protocol.
Participants by arm
| Arm | Count |
|---|---|
| Teleconference Teleconference Intervention arm
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. | 196 |
| Internet Internet Intervention arm
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. | 197 |
| One-to-One One-to-One intervention arm
One-to-one: 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. | 197 |
| Total | 590 |
Baseline characteristics
| Characteristic | Teleconference | Internet | One-to-One | Total |
|---|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 11 | 53 years STANDARD_DEVIATION 11 | 51 years STANDARD_DEVIATION 12 | 52 years STANDARD_DEVIATION 12 |
| Fatigue Impact Scale | 68.62 units on a scale STANDARD_DEVIATION 33.78 | 67.73 units on a scale STANDARD_DEVIATION 33.03 | 68.10 units on a scale STANDARD_DEVIATION 33.61 | 68.15 units on a scale STANDARD_DEVIATION 33.42 |
| Race/Ethnicity, Customized African American | 24 Participants | 23 Participants | 23 Participants | 70 Participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Hawaiian/Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants | 8 Participants | 9 Participants | 21 Participants |
| Race/Ethnicity, Customized Missing Race | 0 Participants | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Multiracial | 6 Participants | 3 Participants | 3 Participants | 12 Participants |
| Race/Ethnicity, Customized Non-Hispanic | 191 Participants | 188 Participants | 187 Participants | 566 Participants |
| Race/Ethnicity, Customized White | 165 Participants | 166 Participants | 171 Participants | 502 Participants |
| Sex: Female, Male Female | 166 Participants | 158 Participants | 161 Participants | 485 Participants |
| Sex: Female, Male Male | 30 Participants | 39 Participants | 36 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 196 | 0 / 197 | 0 / 197 |
| other Total, other adverse events | 0 / 196 | 0 / 197 | 0 / 197 |
| serious Total, serious adverse events | 0 / 196 | 0 / 197 | 0 / 197 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teleconference | Change From Baseline in Fatigue Levels | 50.98 score on a scale | Standard Deviation 2.08 |
| Internet | Change From Baseline in Fatigue Levels | 56.88 score on a scale | Standard Deviation 0.59 |
| One-to-one | Change From Baseline in Fatigue Levels | 57.87 score on a scale | Standard Deviation 1.34 |
Comparison: A generalized estimating equation (GEE) served as the primary analysis tool for modeling the longitudinal scores of the primary outcome - Fatigue Impact Scale (FIS).90% CI: [0.67, 9.11]
Comparison: A generalized estimating equation (GEE) served as the primary analysis tool for modeling the longitudinal scores of the primary outcome - Fatigue Impact Scale (FIS).90% CI: [0.98, 11.26]
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teleconference | Change From Baseline in Health-related Quality of Life: Psychological Composite | 40.93 score on a scale | Standard Deviation 23.05 |
| Internet | Change From Baseline in Health-related Quality of Life: Psychological Composite | 38.66 score on a scale | Standard Deviation 21.8 |
| One-to-one | Change From Baseline in Health-related Quality of Life: Psychological Composite | 37.77 score on a scale | Standard Deviation 21.68 |
p-value: 0.1ANOVA