Status:
COMPLETED
A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Oregon Health and Science University
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 caus...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2015
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT01918800
Start Date
March 28 2013
End Date
December 30 2015
Last Update
July 26 2018
Active Locations (4)
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1
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608
2
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
3
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239
4
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108