A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis
A Randomized Trial of a Formal Group Program for Fatigue in Multiple Sclerosis
1 other identifier
interventional
282
1 country
4
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Mar 2013
Typical duration for not_applicable multiple-sclerosis
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 28, 2013
CompletedFirst Submitted
Initial submission to the registry
August 5, 2013
CompletedFirst Posted
Study publicly available on registry
August 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2015
CompletedResults Posted
Study results publicly available
March 13, 2017
CompletedJuly 26, 2018
June 1, 2018
2.8 years
August 5, 2013
November 15, 2016
June 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4 months
Secondary Outcomes (6)
Multiple Sclerosis Self Efficacy Scale
4 months
Beck Depression Inventory II (BDI-II)
4 months
SF-36
4 months
Rapid Assessment of Physical Activity (RAPA)
4 months
Pittsburgh Sleep Quality Index (PSQI)
4 months
- +1 more secondary outcomes
Study Arms (2)
Fatigue: Take Control
EXPERIMENTALFatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline
MS: Take Control
ACTIVE COMPARATORMS: Take Control includes topics of interest to people with MS other than fatigue.
Interventions
Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline
MS: Take Control includes topics of interest to people with MS other than fatigue.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608, United States
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201, United States
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108, United States
Related Publications (3)
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.
PMID: 29226778RESULTHugos 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.
PMID: 29761722RESULTKnowles 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.
PMID: 34347626DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cinda Hugos
- Organization
- Portland VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis N Bourdette, MD
VA Portland Health Care System, Portland, OR
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2013
First Posted
August 8, 2013
Study Start
March 28, 2013
Primary Completion
December 30, 2015
Study Completion
December 30, 2015
Last Updated
July 26, 2018
Results First Posted
March 13, 2017
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will share
Both Portland and Seattle LSIs have opted to send a letter with a copy of the study to participants in the study.