A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis
A Randomized Trial of a Formal Group Program for Fatigue in Multiple Sclerosis
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Modified Fatigue Impact Scale | .64 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Fatigue: Take control
Compared with
- MS: Take Control
Results by group
Modified Fatigue Impact Scale
4 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fatigue: Take Control | 46.1 units on a scale | 12.2 (Standard Deviation) | 109 |
| MS: Take Control | 46.7 units on a scale | 11.9 (Standard Deviation) | 109 |
Fatigue: Take Control
MS: Take Control
p = .64
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Fatigue: Take Control | 109 | 12 (11.0%) | |
| MS: Take Control | 109 | 10 (9.2%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Modified Fatigue Impact Scale
4 months
Thinking and memoryFatigue
Other measures (6)
Multiple Sclerosis Self Efficacy Scale
4 months
Beck Depression Inventory II (BDI-II)
4 months
FatigueBladder, bowel and sexual functionMood and sleepSF-36
4 months
Quality of life (reported by participants)Rapid Assessment of Physical Activity (RAPA)
4 months
Physical functionPittsburgh Sleep Quality Index (PSQI)
4 months
Myelin repairMood and sleepTimed 25 Foot Walk (T25-FW)
4 months
Disability progressionWalking and mobility
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* 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
Exclusion criteria
* 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Improvement in depressive symptoms is associated with sustained improvement in fatigue impact in adults with multiple sclerosis.Mult Scler Relat Disord · 2024
Results
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.Results
Hugos 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.Results
Knowles 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.
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History
Started
Mar 2013
Main results due
Dec 2015
Finished
Dec 2015
Results posted
Mar 2017