A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

A Randomized Trial of a Formal Group Program for Fatigue in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918800
• Other study ID #: F7777-R
• Status: Completed
• Phase: N/A
• Start date: March 28, 2013
• Est. completion date: December 30, 2015

Study information

• Verified date: June 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: December 30, 2015
• Est. primary completion date: December 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland
United States	North Florida/South Georgia Veterans Health System, Gainesville, FL	Gainesville	Florida
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

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. 2018 May 1:1352458518775920. doi: 10.11 — View 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 m — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Fatigue Impact Scale	The self-report, retrospective MFIS measures fatigue symptoms. The full-length MFIS consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of .81. The MFIS provides a total score and scores for each of three subscales (physical, cognitive and psychosocial) and lower scores on the MFIS and its subscales indicate less fatigue. This is the primary outcome measure for the proposed study and is widely used to assess fatigue in MS.	4 months
Secondary	Multiple Sclerosis Self Efficacy Scale	The self-report, retrospective MSSE is an 18-item scale of self-efficacy specifically designed for MS patients. This easy to use self-report measure demonstrates internal consistency estimates of about .89 for the full scale and a .75 test-retest correlation. Higher scores on the MSSE indicate higher self-efficacy. Scores range from 180-1800.	4 months
Secondary	Beck Depression Inventory II (BDI-II)	The self-report, retrospective BDI-II is a validated 21-item self-report measure of depression widely used in MS studies . Each item is scored between 0 and 3. It is reported to have good reliability (Cronbach's alpha of .81) and validity. Assessing for depression is part of the inclusion/exclusion criteria. Excluding subjects with severe depression is necessary to avoid confounding effects of fatigue and depression. Score range (0-63). Higher scores indicate greater depression.	4 months
Secondary	SF-36	The SF-36 is a validated measure of health-related quality of life. It is sensitive to change, has appropriate psychometric properties and is frequently used in MS studies. Measures of health-related quality of life are recommended in the systematic review of self-management in neurological disorders. The range for the physical component score is 13.6-61.9. The range for the mental component scores is 15.6-70.0.	4 months
Secondary	Rapid Assessment of Physical Activity (RAPA)	The self-report, retrospective Rapid Assessment of Physical Activity (RAPA) was developed to provide an easily administered and interpreted means of assessing levels of physical activity among adults older than 50 years. The RAPA is an easy-to-use, valid measure of physical activity for use in clinical practice with older adults. A tool for older adults will be easy to use for people with MS who may not be regular exercisers. Each question has a 'Yes' or 'No' option. The total score of the first seven items is out of 7; participants choose which question corresponds to their activity level. Any score less than 6 is considered suboptimal. From these values we provided a percentage of the number of people exercising optimally in the RAPA Cardiovascular.; Strength training and flexibility are scored separately (strength training = 1, flexibility = 2, both = 3). Based on total scores we provided a percentage of people at optimum strength and flexibility.	4 months
Secondary	Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a l-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score between 0-21. Higher scores indicate worse sleep quality.	4 months
Secondary	Timed 25 Foot Walk (T25-FW)	The time to walk 8 meters or 25 feet is strongly related to its ordinal counterpart the Ambulation Index (Spearman r = 0.91), without the variability that the ordinal scale reflects.T25-FW was used in this study to measure ambulation status and as an additional measure of mobility. The score for the T25-FWis the average of the two completed trials in seconds	4 months