A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis

Completed · Not applicable

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT01918800

Run by

VA Office of Research and Development

People needed

282

Starts

2013-03-28

Expected to finish

2015-12-30

Last updated by the study team

2018-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States
• Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States
• VA Portland Health Care System, Portland, OR — Portland, Oregon, United States
• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.