Multiple SclerosisNCT03550170
Fatigue Management Programs for People With MS
A study testing Teleconference, Internet and 1-to-1, in-person or videoconference in people with Multiple Sclerosis, run by Case Western Reserve University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Teleconference, Internet and 1-to-1, in-person or videoconference
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2019to 28 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-report diagnosis of MS
- Age ≥ 18 years
- Fatigue Severity Scale score ≥ 4
- Ability to speak English
Who cannot join
- Individual must be capable of providing consent (Assessed with questionnaire)
- Unable to access the internet or unable to travel to in-person sessions
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Illinois at Chicago
Chicago, Illinois, 60612
Case Western Reserve University
Cleveland, Ohio, 44106
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Comparing the Effectiveness of Fatigue Management Programs for People With MS
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Teleconference, Internet, 1-to-1, in-person or videoconference
- Keywords
- Fatigue, Wellness, Multiple Sclerosis, Quality of life
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleconferenceBehavioural
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.
InternetBehavioural
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.
1-to-1, in-person or videoconferenceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Teleconference | Active comparator | Teleconference Intervention arm Receives: Behavioral: Teleconference |
| Internet | Active comparator | Internet Intervention arm Receives: Behavioral: Internet |
| I-to-1, in-person or videoconference | Active comparator | 1-to-1, in-person or videoconference intervention arm Receives: Behavioral: 1-to-1, in-person or videoconference |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 6 months
Secondary outcomes (1)
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.
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Mar 2019
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Illinois at Chicago, University of Minnesota, Queen's University, Kingston, Ontario, Dalhousie University, The Cleveland Clinic
- Responsible party
- Principal investigator, Matthew Plow, Case Western Reserve University
- Investigators
- Matthew Plow, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550170
- Sponsor's protocol ID
- MS-1610-37015
- Status last verified
- Jan 2025
- First submitted
- 24 May 2018
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Plow M, Packer T, Mathiowetz VG, Preissner K, Ghahari S, Sattar A, Bethoux F, Finlayson M. REFRESH protocol: a non-inferiority randomised clinical trial comparing internet and teleconference to in-person 'Managing Fatigue' interventions on the impact of fatigue among persons with multiple sclerosis. BMJ Open. 2020 Aug 16;10(8):e035470. doi: 10.1136/bmjopen-2019-035470.
PubMed 32801193
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Fatigue Management Programs for People With MS
- ClinicalTrials.gov ID
- NCT03550170
- Acronym / sponsor ID
- MS-1610-37015
- Conditions
- Multiple Sclerosis
- Keywords
- Fatigue, Wellness, Multiple Sclerosis, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Illinois at Chicago, University of Minnesota, Queen's University, Kingston, Ontario, Dalhousie University, The Cleveland Clinic
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Teleconference | Active comparator | Behavioral: TeleconferenceTeleconference Intervention arm |
| Internet | Active comparator | Behavioral: InternetInternet Intervention arm |
| I-to-1, in-person or videoconference | Active comparator | Behavioral: 1-to-1, in-person or videoconference1-to-1, in-person or videoconference intervention arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-report diagnosis of MS
- Age ≥ 18 years
- Fatigue Severity Scale score ≥ 4
- Ability to speak English
Key exclusion criteria (2 listed)
- Individual must be capable of providing consent (Assessed with questionnaire)
- Unable to access the internet or unable to travel to in-person sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeleconferenceThis 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. | Behavioural | Teleconference |
| InternetThe 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. | Behavioural | Internet |
| 1-to-1, in-person or videoconferenceUnlike 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. | Behavioural | I-to-1, in-person or videoconference |
Primary outcome
Change From Baseline in Fatigue Levels
Time frame: 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.
1 secondary outcome
Change From Baseline in Health-related Quality of Life: Psychological Composite
Time frame: Change from baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32801193Plow M, Packer T, Mathiowetz VG, Preissner K, Ghahari S, Sattar A, Bethoux F, Finlayson M. REFRESH protocol: a non-inferiority randomised clinical trial comparing internet and teleconference to in-person 'Managing Fatigue' interventions on the impact of fatigue among persons with multiple sclerosis. BMJ Open. 2020 Aug 16;10(8):e035470. doi: 10.1136/bmjopen-2019-035470.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Plow, PhD principal investigator
Case Western Reserve University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleconference, Internet and 1-to-1, in-person or videoconference in people with Multiple Sclerosis, run by Case Western Reserve University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Fatigue Levels (time frame: Change from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03550170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.