Clinical trial NCT01918800: A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis
Official title: A Randomized Trial of a Formal Group Program for Fatigue in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: fatigue
quality of life
rehabilitation
self management
energy effectiveness
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Oregon Health and Science University
First posted: 2013-08-08
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

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, 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.

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

Primary outcomes:
measure: Modified Fatigue Impact Scale
timeFrame: 4 months
Secondary outcomes:
measure: Multiple Sclerosis Self Efficacy Scale
timeFrame: 4 months
measure: Beck Depression Inventory II (BDI-II)
timeFrame: 4 months
measure: SF-36
timeFrame: 4 months
measure: Rapid Assessment of Physical Activity (RAPA)
timeFrame: 4 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4 months
measure: Timed 25 Foot Walk (T25-FW)
timeFrame: 4 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
state: Florida
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Dennis N Bourdette, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hugos CL, Chen Z, Chen Y, Turner AP, Haselkorn J, Chiara T, McCoy S, Bever CT Jr, Cameron MH, Bourdette D; VA MS Fatigue Study Group. A multicenter randomized controlled trial of two group education programs for fatigue in multiple sclerosis: Short- and medium-term benefits. Mult Scler. 2019 Feb;25(2):275-285. doi: 10.1177/1352458517745723. Epub 2017 Dec 11.
citation: Hugos CL, Cameron MH, Chen Z, Chen Y, Bourdette D. A multicenter randomized controlled trial of two group education programs for fatigue in multiple sclerosis: Long-term (12-month) follow-up at one site. Mult Scler. 2019 May;25(6):871-875. doi: 10.1177/1352458518775920. Epub 2018 May 15.
citation: Knowles LM, Hugos CL, Cameron MH, Haselkorn JK, Bourdette DN, Turner AP. Moderators of Improvements in Fatigue Impact After a Self-management Intervention in Multiple Sclerosis: A Secondary Analysis of a Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Apr 1;101(4):405-409. doi: 10.1097/PHM.0000000000001861.