N/A
N=218
A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01918800 ↗Enrolled (actual)
218
Serious AEs
10.1%
Results posted
Mar 2017
Primary outcome: Primary: Modified Fatigue Impact Scale — 46.1; 46.7 units on a scale — p=.64
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fatigue: Take control (Behavioral); MS: Take Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Fatigue Impact Scale |
46.1; 46.7 | .64 |
| SECONDARY Multiple Sclerosis Self Efficacy Scale |
1434.5; 1352.5 | 0.04 sig |
| SECONDARY Beck Depression Inventory II (BDI-II) |
9.5; 10.7 | 0.35 |
| SECONDARY SF-36 |
24.5; 24.3; 23.9; 23.8 | 0.8 |
| SECONDARY Rapid Assessment of Physical Activity (RAPA) |
40; 33; 51; 53; 69; 64 | 0.521 |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
7.41; 7.71 | 0.42 |
| SECONDARY Timed 25 Foot Walk (T25-FW) |
8.17; 10.55 | 0.36 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01918800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.