Trial Outcomes & Findings for Fatigue Management Programs for People With MS (NCT NCT03550170)

Last Updated: 2025-02-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

590 participants

Primary outcome timeframe

Change from baseline to 6 months

Results posted on

2025-02-04

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.	One-to-One One-to-one intervention arm: Unlike the teleconference and internet courses, the number and length of sessions for the one-to-one 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.
Overall Study STARTED	196	197	197
Overall Study COMPLETED	174	186	172
Overall Study NOT COMPLETED	22	11	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fatigue Management Programs for People With MS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Teleconference n=196 Participants 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.	Internet n=197 Participants 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.	One-to-One n=197 Participants 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.	Total n=590 Participants Total of all reporting groups
Race/Ethnicity, Customized African American	24 Participants n=5 Participants	23 Participants n=7 Participants	23 Participants n=5 Participants	70 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized White	165 Participants n=5 Participants	166 Participants n=7 Participants	171 Participants n=5 Participants	502 Participants n=4 Participants
Age, Continuous	52 years STANDARD_DEVIATION 11 • n=5 Participants	53 years STANDARD_DEVIATION 11 • n=7 Participants	51 years STANDARD_DEVIATION 12 • n=5 Participants	52 years STANDARD_DEVIATION 12 • n=4 Participants
Sex: Female, Male Female	166 Participants n=5 Participants	158 Participants n=7 Participants	161 Participants n=5 Participants	485 Participants n=4 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	39 Participants n=7 Participants	36 Participants n=5 Participants	105 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	4 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	21 Participants n=4 Participants
Race/Ethnicity, Customized Non-Hispanic	191 Participants n=5 Participants	188 Participants n=7 Participants	187 Participants n=5 Participants	566 Participants n=4 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Hawaiian/Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Multiracial	6 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants
Race/Ethnicity, Customized Missing Race	0 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Fatigue Impact Scale	68.62 units on a scale STANDARD_DEVIATION 33.78 • n=5 Participants	67.73 units on a scale STANDARD_DEVIATION 33.03 • n=7 Participants	68.10 units on a scale STANDARD_DEVIATION 33.61 • n=5 Participants	68.15 units on a scale STANDARD_DEVIATION 33.42 • n=4 Participants

PRIMARY outcome

Timeframe: Change from baseline to 6 months

Outcome measures

Outcome measures
Measure	Teleconference n=196 Participants 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.	Internet n=197 Participants 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.	One-to-one n=197 Participants One-to-one intervention arm One-to-one, in-person or videoconference: 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	50.98 score on a scale Standard Deviation 2.08	56.88 score on a scale Standard Deviation 0.59	57.87 score on a scale Standard Deviation 1.34

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Teleconference n=163 Participants 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.	Internet n=131 Participants 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.	One-to-one n=145 Participants One-to-one intervention arm One-to-one, in-person or videoconference: 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 Health-related Quality of Life: Psychological Composite	40.93 score on a scale Standard Deviation 23.05	38.66 score on a scale Standard Deviation 21.80	37.77 score on a scale Standard Deviation 21.68

Adverse Events

Teleconference

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Internet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

One-to-One

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Matthew Plow

Case Western Reserve University

Phone: 216-368-8969

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place