Multiple SclerosisNCT01918800
A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis
A study of Multiple Sclerosis, run by VA Office of Research and Development at 4 sites in United States.
Trial summary
The purpose of this study is to compare two different educational programs for people with multiple sclerosis (MS), which is a common and often disabling disease of the central nervous system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Mar 2013to 30 Dec 2015
- 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
- A diagnosis of MS by 2010 updated McDonald Criteria
- At least 18 years of age
- Able to walk 60 feet without human assistance or architectural support (walls) but with any personal assistive device (cane, crutches, walker) (EDSS-S of 6.5 or less at Visit 1)
- Fluent in written and spoken English, as educational intervention and questionnaires have not been validated in languages other than English.
- Score of greater than 25 on MFIS indicating MS-related fatigue
Who cannot join
- Severe depression (score on the Beck Depression Inventory II greater than 28)
- Current substance abuse disorder or psychosis
- Any significant uncontrolled medical problem that would limit participation or completion of the study
- MS relapse within the 30 days before screening
- Initiation of new disease modifying treatment within 3 months prior to start of study or participating in an interventional research study
- Current or prior participation in a fatigue management program
- Pregnant women
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: A Randomized Trial of a Formal Group Program for Fatigue in Multiple Sclerosis
The purpose of this study is to compare two different educational programs for people with multiple sclerosis (MS), which is a common and often disabling disease of the central nervous system. MS causes many symptoms including difficulty walking, loss of balance or muscle coordination, fatigue, numbness and tingling and stiffness. The investigators want to determine which program is better at helping improve quality of life and MS symptoms. Both programs use material from the National Multiple Sclerosis Society (NMSS). Both programs include 6 weekly 2-hour class sessions. Up to 600 participants will be enrolled total in 4 VA sites, with about 150 at each site. There will be 10 study visits, all to occur within 11 months. These include 1 baseline visit, 6 two-hour class visits, and 3 follow-up data collection visits. The participants in Portland will also participate in a final 12 month followup visit. Participants will be randomly (by chance) assigned to be part of either group education program. They will have a 1:1 or 50% chance of being in either program.
Read the detailed description
Treatment of MS-related fatigue represents a significant challenge in providing symptomatic therapy for people with MS. In 1998 the MS Council for Clinical Practice Guidelines published Fatigue and MS, the first evidence based treatment guideline for MS recommending comprehensive treatment for fatigue. This guideline is widely distributed, but does not include a program for implementation. Fatigue: Take Control, is the first formal program modeled on the MS fatigue guidelines. This proposal entails performing a four-center single blind intent-to-treat randomized controlled two-arm parallel design trial of Fatigue: Take Control with MS participants to accomplish three Specific Aims.
Specific Aim #1: Demonstrate that Fatigue: Take Control reduces fatigue in people with MS who are ambulatory and not depressed at the end of the intervention and at three and six months after the intervention compared to a general MS group education program. The primary outcome measure will be the Modified Fatigue Impact Scale (MFIS) chosen for its multi-dimensional nature, recommended use in the Fatigue and MS guideline and sensitivity to change in the pilot study.
Specific Aim #2: Demonstrate that Fatigue: Take Control increases self-efficacy in people with MS who are ambulatory and not severely depressed. Fatigue affects a person's sense of control over his/her life. The investigators will use the MS Self Efficacy Scale (MSSE) for this secondary objective. This measure also demonstrated improvement in the pilot study.
Specific Aim #3: Demonstrate that Fatigue: Take Control results in changes in medication utilization, exercise participation, sleep and health-related quality of life in people with MS who are ambulatory and not depressed. Fatigue affects body functions/structure, activity and participation in all aspects of daily life. Fatigue: Take Control was created with the expectation that fatigue can be reduced by guiding individuals to make the environmental, behavioral and lifestyle changes necessary to manage MS fatigue. This objective will explore important secondary causes of fatigue that impact health-related quality of life by identifying participant changes in: timed walk using the time to walk 25 feet (T25-FW), medication utilization using a self-report medication diary, exercise participation using the self-report Rapid Assessment of Physical Activity (RAPA), sleep quality using the Pittsburgh Sleep Quality Index (PSQI) and changes in overall health-related quality of life using the SF-36.
- Conditions
- Multiple Sclerosis
- Being tested
- Fatigue: Take control, MS: Take Control
- Keywords
- fatigue, quality of life, rehabilitation, self management, energy effectiveness
- 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.
Fatigue: Take controlBehavioural
Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline
MS: Take ControlBehavioural
MS: Take Control includes topics of interest to people with MS other than fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Fatigue: Take Control | Experimental | Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline Receives: Behavioral: Fatigue: Take control |
| MS: Take Control | Active comparator | MS: Take Control includes topics of interest to people with MS other than fatigue. Receives: Behavioral: MS: Take Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Fatigue Impact Scale
The self-report, retrospective MFIS measures fatigue symptoms. The full-length MFIS consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of .81. The MFIS provides a total score and scores for each of three subscales (physical, cognitive and psychosocial) and lower scores on the MFIS and its subscales indicate less fatigue. This is the primary outcome measure for the proposed study and is widely used to assess fatigue in MS.
Measured: 4 months
Secondary outcomes (6)
Multiple Sclerosis Self Efficacy Scale
The self-report, retrospective MSSE is an 18-item scale of self-efficacy specifically designed for MS patients. This easy to use self-report measure demonstrates internal consistency estimates of about .89 for the full scale and a .75 test-retest correlation. Higher scores on the MSSE indicate higher self-efficacy. Scores range from 180-1800.
Measured: 4 months
Beck Depression Inventory II (BDI-II)
The self-report, retrospective BDI-II is a validated 21-item self-report measure of depression widely used in MS studies . Each item is scored between 0 and 3. It is reported to have good reliability (Cronbach's alpha of .81) and validity. Assessing for depression is part of the inclusion/exclusion criteria. Excluding subjects with severe depression is necessary to avoid confounding effects of fatigue and depression. Score range (0-63). Higher scores indicate greater depression.
Measured: 4 months
SF-36
The SF-36 is a validated measure of health-related quality of life. It is sensitive to change, has appropriate psychometric properties and is frequently used in MS studies. Measures of health-related quality of life are recommended in the systematic review of self-management in neurological disorders. The range for the physical component score is 13.6-61.9. The range for the mental component scores is 15.6-70.0.
Measured: 4 months
Rapid Assessment of Physical Activity (RAPA)
The self-report, retrospective Rapid Assessment of Physical Activity (RAPA) was developed to provide an easily administered and interpreted means of assessing levels of physical activity among adults older than 50 years. The RAPA is an easy-to-use, valid measure of physical activity for use in clinical practice with older adults. A tool for older adults will be easy to use for people with MS who may not be regular exercisers. Each question has a 'Yes' or 'No' option. The total score of the first seven items is out of 7; participants choose which question corresponds to their activity level. Any score less than 6 is considered suboptimal. From these values we provided a percentage of the number of people exercising optimally in the RAPA Cardiovascular.
Strength training and flexibility are scored separately (strength training = 1, flexibility = 2, both = 3). Based on total scores we provided a percentage of people at optimum strength and flexibility.
Measured: 4 months
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a l-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score between 0-21. Higher scores indicate worse sleep quality.
Measured: 4 months
Timed 25 Foot Walk (T25-FW)
The time to walk 8 meters or 25 feet is strongly related to its ordinal counterpart the Ambulation Index (Spearman r = 0.91), without the variability that the ordinal scale reflects.T25-FW was used in this study to measure ambulation status and as an additional measure of mobility. The score for the T25-FWis the average of the two completed trials in seconds
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study start28 Mar 2013
- Primary completion30 Dec 2015
- Study completion30 Dec 2015
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 (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Dennis N Bourdette, MD, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918800
- Sponsor's protocol ID
- F7777-R
- Status last verified
- Jun 2018
- First submitted
- 5 Aug 2013
- Last updated
- 26 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Both Portland and Seattle LSIs have opted to send a letter with a copy of the study to participants in the study.
Publications
Hugos CL, Chen Z, Chen Y, Turner AP, Haselkorn J, Chiara T, McCoy S, Bever CT Jr, Cameron MH, Bourdette D; VA MS Fatigue Study Group. A multicenter randomized controlled trial of two group education programs for fatigue in multiple sclerosis: Short- and medium-term benefits. Mult Scler. 2019 Feb;25(2):275-285. doi: 10.1177/1352458517745723. Epub 2017 Dec 11.
PubMed 29226778Hugos CL, Cameron MH, Chen Z, Chen Y, Bourdette D. A multicenter randomized controlled trial of two group education programs for fatigue in multiple sclerosis: Long-term (12-month) follow-up at one site. Mult Scler. 2019 May;25(6):871-875. doi: 10.1177/1352458518775920. Epub 2018 May 15.
PubMed 29761722Knowles LM, Hugos CL, Cameron MH, Haselkorn JK, Bourdette DN, Turner AP. Moderators of Improvements in Fatigue Impact After a Self-management Intervention in Multiple Sclerosis: A Secondary Analysis of a Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Apr 1;101(4):405-409. doi: 10.1097/PHM.0000000000001861.
PubMed 34347626
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of a Formal Group Program for Fatigue in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01918800
- Acronym / sponsor ID
- F7777-R
- Conditions
- Multiple Sclerosis
- Keywords
- fatigue, quality of life, rehabilitation, self management, energy effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Oregon Health and Science University
- Study start
- 28 Mar 2013 (actual)
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 8 Aug 2013 (estimated)
- Results
- Posted 13 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two different educational programs for people with multiple sclerosis (MS), which is a common and often disabling disease of the central nervous system. MS causes many symptoms including difficulty walking, loss of balance or muscle coordination, fatigue, numbness and tingling and stiffness. The investigators want to determine which program is better at helping improve quality of life and MS symptoms. Both programs use material from the National Multiple Sclerosis Society (NMSS). Both programs include 6 weekly 2-hour class sessions. Up to 600 participants will be enrolled total in 4 VA sites, with about 150 at each site. There will be 10 study visits, all to occur within 11 months. These include 1 baseline visit, 6 two-hour class visits, and 3 follow-up data collection visits. The participants in Portland will also participate in a final 12 month followup visit. Participants will be randomly (by chance) assigned to be part of either group education program. They will have a 1:1 or 50% chance of being in either program.
Detailed description
Treatment of MS-related fatigue represents a significant challenge in providing symptomatic therapy for people with MS. In 1998 the MS Council for Clinical Practice Guidelines published Fatigue and MS, the first evidence based treatment guideline for MS recommending comprehensive treatment for fatigue. This guideline is widely distributed, but does not include a program for implementation. Fatigue: Take Control, is the first formal program modeled on the MS fatigue guidelines. This proposal entails performing a four-center single blind intent-to-treat randomized controlled two-arm parallel design trial of Fatigue: Take Control with MS participants to accomplish three Specific Aims.
Specific Aim #1: Demonstrate that Fatigue: Take Control reduces fatigue in people with MS who are ambulatory and not depressed at the end of the intervention and at three and six months after the intervention compared to a general MS group education program. The primary outcome measure will be the Modified Fatigue Impact Scale (MFIS) chosen for its multi-dimensional nature, recommended use in the Fatigue and MS guideline and sensitivity to change in the pilot study.
Specific Aim #2: Demonstrate that Fatigue: Take Control increases self-efficacy in people with MS who are ambulatory and not severely depressed. Fatigue affects a person's sense of control over his/her life. The investigators will use the MS Self Efficacy Scale (MSSE) for this secondary objective. This measure also demonstrated improvement in the pilot study.
Specific Aim #3: Demonstrate that Fatigue: Take Control results in changes in medication utilization, exercise participation, sleep and health-related quality of life in people with MS who are ambulatory and not depressed. Fatigue affects body functions/structure, activity and participation in all aspects of daily life. Fatigue: Take Control was created with the expectation that fatigue can be reduced by guiding individuals to make the environmental, behavioral and lifestyle changes necessary to manage MS fatigue. This objective will explore important secondary causes of fatigue that impact health-related quality of life by identifying participant changes in: timed walk using the time to walk 25 feet (T25-FW), medication utilization using a self-report medication diary, exercise participation using the self-report Rapid Assessment of Physical Activity (RAPA), sleep quality using the Pittsburgh Sleep Quality Index (PSQI) and changes in overall health-related quality of life using the SF-36.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fatigue: Take Control | Experimental | Behavioral: Fatigue: Take controlFatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline |
| MS: Take Control | Active comparator | Behavioral: MS: Take ControlMS: Take Control includes topics of interest to people with MS other than fatigue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A diagnosis of MS by 2010 updated McDonald Criteria
- At least 18 years of age
- Able to walk 60 feet without human assistance or architectural support (walls) but with any personal assistive device (cane, crutches, walker) (EDSS-S of 6.5 or less at Visit 1)
- Fluent in written and spoken English, as educational intervention and questionnaires have not been validated in languages other than English.
- Score of greater than 25 on MFIS indicating MS-related fatigue
Key exclusion criteria (7 listed)
- Severe depression (score on the Beck Depression Inventory II greater than 28)
- Current substance abuse disorder or psychosis
- Any significant uncontrolled medical problem that would limit participation or completion of the study
- MS relapse within the 30 days before screening
- Initiation of new disease modifying treatment within 3 months prior to start of study or participating in an interventional research study
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 |
|---|---|---|
| Fatigue: Take controlFatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline | Behavioural | Fatigue: Take Control |
| MS: Take ControlMS: Take Control includes topics of interest to people with MS other than fatigue. | Behavioural | MS: Take Control |
Primary outcome
Modified Fatigue Impact Scale
Time frame: 4 months
The self-report, retrospective MFIS measures fatigue symptoms. The full-length MFIS consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of .81. The MFIS provides a total score and scores for each of three subscales (physical, cognitive and psychosocial) and lower scores on the MFIS and its subscales indicate less fatigue. This is the primary outcome measure for the proposed study and is widely used to assess fatigue in MS.
6 secondary outcomes
Multiple Sclerosis Self Efficacy Scale
Time frame: 4 months
Beck Depression Inventory II (BDI-II)
Time frame: 4 months
SF-36
Time frame: 4 months
Rapid Assessment of Physical Activity (RAPA)
Time frame: 4 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 4 months
Timed 25 Foot Walk (T25-FW)
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29226778Hugos CL, Chen Z, Chen Y, Turner AP, Haselkorn J, Chiara T, McCoy S, Bever CT Jr, Cameron MH, Bourdette D; VA MS Fatigue Study Group. A multicenter randomized controlled trial of two group education programs for fatigue in multiple sclerosis: Short- and medium-term benefits. Mult Scler. 2019 Feb;25(2):275-285. doi: 10.1177/1352458517745723. Epub 2017 Dec 11.
- Results publication: PubMed 29761722Hugos CL, Cameron MH, Chen Z, Chen Y, Bourdette D. A multicenter randomized controlled trial of two group education programs for fatigue in multiple sclerosis: Long-term (12-month) follow-up at one site. Mult Scler. 2019 May;25(6):871-875. doi: 10.1177/1352458518775920. Epub 2018 May 15.
- Derived from this study: PubMed 34347626Knowles LM, Hugos CL, Cameron MH, Haselkorn JK, Bourdette DN, Turner AP. Moderators of Improvements in Fatigue Impact After a Self-management Intervention in Multiple Sclerosis: A Secondary Analysis of a Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Apr 1;101(4):405-409. doi: 10.1097/PHM.0000000000001861.
- Individual participant dataSharing planned: Yes. Both Portland and Seattle LSIs have opted to send a letter with a copy of the study to participants in the study.
Related trials for Multiple Sclerosis
RecruitingPhase 3
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Relapsing Multiple Sclerosis
Active, not recruitingObservational study
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Study of Skin Tumors in Tuberous Sclerosis
Tuberous Sclerosis
Recruiting
The Effects of Synchronous and Asynchronous Pilates Training Based on Telerehabilitation on Core Stabilization, Balance, Cognitive Functions, and Quality of Life in Individuals With Multiple Sclerosis: A Single-Blind Randomized Controlled Trial
Multiple Sclerosis
RecruitingObservational study
Care in Multiple Sclerosis (MS)
Multiple Sclerosis
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.
Dennis N Bourdette, MD principal investigator
VA Portland Health Care System, Portland, OR
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Multiple Sclerosis, run by VA Office of Research and Development at 4 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 5 inclusion and 7 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 13 Mar 2017). 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?
Modified Fatigue Impact Scale (time frame: 4 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 NCT01918800, which also lists 3 linked publications.
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 26 Jul 2018.