A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis

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VA Office of Research and Development

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Behavioral: Fatigue: Take control
Behavioral: MS: Take Control

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01918800
F7777-R

Details and patient eligibility

About

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.

Full 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, 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.

Enrollment

282 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

282 participants in 2 patient groups

Fatigue: Take Control
Experimental group
Description:
Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline
Treatment:
Behavioral: Fatigue: Take control
MS: Take Control
Active Comparator group
Description:
MS: Take Control includes topics of interest to people with MS other than fatigue.
Treatment:
Behavioral: MS: Take Control

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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