A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/27/2018 |
| Start Date: | March 28, 2013 |
| End Date: | December 30, 2015 |
A Randomized Trial of a Formal Group Program for Fatigue in Multiple Sclerosis
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.
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.
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, the first evidence based treatment guideline for MS recommending
comprehensive treatment for fatigue. This guideline is widely distributed, but does not
include a program for implementation. Fatigue: Take Control, is the first formal program
modeled on the MS fatigue guidelines. This proposal entails performing a four-center single
blind intent-to-treat randomized controlled two-arm parallel design trial of Fatigue: Take
Control with MS participants to accomplish three Specific Aims.
Specific Aim #1: Demonstrate that Fatigue: Take Control reduces fatigue in people with MS who
are ambulatory and not depressed at the end of the intervention and at three and six months
after the intervention compared to a general MS group education program. The primary outcome
measure will be the Modified Fatigue Impact Scale (MFIS) chosen for its multi-dimensional
nature, recommended use in the Fatigue and MS guideline and sensitivity to change in the
pilot study.
Specific Aim #2: Demonstrate that Fatigue: Take Control increases self-efficacy in people
with MS who are ambulatory and not severely depressed. Fatigue affects a person's sense of
control over his/her life. The investigators will use the MS Self Efficacy Scale (MSSE) for
this secondary objective. This measure also demonstrated improvement in the pilot study.
Specific Aim #3: Demonstrate that Fatigue: Take Control results in changes in medication
utilization, exercise participation, sleep and health-related quality of life in people with
MS who are ambulatory and not depressed. Fatigue affects body functions/structure, activity
and participation in all aspects of daily life. Fatigue: Take Control was created with the
expectation that fatigue can be reduced by guiding individuals to make the environmental,
behavioral and lifestyle changes necessary to manage MS fatigue. This objective will explore
important secondary causes of fatigue that impact health-related quality of life by
identifying participant changes in: timed walk using the time to walk 25 feet (T25-FW),
medication utilization using a self-report medication diary, exercise participation using the
self-report Rapid Assessment of Physical Activity (RAPA), sleep quality using the Pittsburgh
Sleep Quality Index (PSQI) and changes in overall health-related quality of life using the
SF-36.
therapy for people with MS. In 1998 the MS Council for Clinical Practice Guidelines published
Fatigue and MS, the first evidence based treatment guideline for MS recommending
comprehensive treatment for fatigue. This guideline is widely distributed, but does not
include a program for implementation. Fatigue: Take Control, is the first formal program
modeled on the MS fatigue guidelines. This proposal entails performing a four-center single
blind intent-to-treat randomized controlled two-arm parallel design trial of Fatigue: Take
Control with MS participants to accomplish three Specific Aims.
Specific Aim #1: Demonstrate that Fatigue: Take Control reduces fatigue in people with MS who
are ambulatory and not depressed at the end of the intervention and at three and six months
after the intervention compared to a general MS group education program. The primary outcome
measure will be the Modified Fatigue Impact Scale (MFIS) chosen for its multi-dimensional
nature, recommended use in the Fatigue and MS guideline and sensitivity to change in the
pilot study.
Specific Aim #2: Demonstrate that Fatigue: Take Control increases self-efficacy in people
with MS who are ambulatory and not severely depressed. Fatigue affects a person's sense of
control over his/her life. The investigators will use the MS Self Efficacy Scale (MSSE) for
this secondary objective. This measure also demonstrated improvement in the pilot study.
Specific Aim #3: Demonstrate that Fatigue: Take Control results in changes in medication
utilization, exercise participation, sleep and health-related quality of life in people with
MS who are ambulatory and not depressed. Fatigue affects body functions/structure, activity
and participation in all aspects of daily life. Fatigue: Take Control was created with the
expectation that fatigue can be reduced by guiding individuals to make the environmental,
behavioral and lifestyle changes necessary to manage MS fatigue. This objective will explore
important secondary causes of fatigue that impact health-related quality of life by
identifying participant changes in: timed walk using the time to walk 25 feet (T25-FW),
medication utilization using a self-report medication diary, exercise participation using the
self-report Rapid Assessment of Physical Activity (RAPA), sleep quality using the Pittsburgh
Sleep Quality Index (PSQI) and changes in overall health-related quality of life using the
SF-36.
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
We found this trial at
4
sites
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