Ignite Creation Date:
2024-05-06 @ 1:51 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01918800
Status:
COMPLETED
Last Update Posted:
2018-07-26
First Post:
2013-08-05
Brief Title:
A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
A Randomized Trial of a Formal Group Program for Fatigue in Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 persons sense of control over hisher 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 functionsstructure 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
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 persons sense of control over hisher 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 functionsstructure 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None