A randomized trial of a formal group program for fatigue in multiple sclerosis

描述(由申请人提供)： 本研究项目的目的是确定疲劳：采取控制(FTC)，一个由国家多发性硬化症(MS)学会(NMSS)拥有和分发的正式多模式计划，基于疲劳和MS临床实践指南，是否在减少退伍军人和其他MS患者的疲劳方面有效。具体目标是：1)确定FTC是否在干预结束时和干预后3、6和12个月减少非抑郁的MS患者的疲劳，与普通MS组教育计划的修改后的疲劳影响量表，主要结果衡量；2)确定在MS患者中，FTC是否比普通MS组教育计划提高了自我效能感，如MS自我效能量表所测量的；3)确定FTC是否导致受试者报告a)使用自我报告的药物日记的药物利用的变化，b)使用体力活动快速自我评估的锻炼参与，以及c)使用SF-36的生活质量， 以及4)确定与使用StepWatch活动监测器(SAM)的一般MS小组教育计划相比，FTC是否客观地增加了活动参与度。200名受试者(每只手臂100名)将在波特兰、西雅图、巴尔的摩和盖恩斯维尔这四个退伍军人管理局地点各招募50名受试者，参加一项双臂随机单盲对照平行治疗试验。重要的是要在至少4个地点进行试验，以确定该计划在不同地点、不同主持人的情况下是有效的，并采用适当的控制干预措施进行控制 用于社会化和内容，并确保快速入学。受试者将随机参加FTC(包括观看DVD、讨论、家庭作业和练习册)或不解决疲劳的一般MS教育计划(包括讨论和NMSS制作的材料)。受试者将参加每周两个小时的小组课程，为期6周，主要结果数据收集在基线和完成课程后一周。在完成各自计划的3个月和6个月后，受试者将接受重复评估，以评估反应的持久性，然后退出研究。受试者将从退伍军人管理局多发性硬化症诊所、附属医学院的多发性硬化症诊所和社区招募，以确保妇女和少数民族的参与。在初步研究中，与基线MFI的标准差约为10。这意味着每组约40人将提供80%的力量来检测7个单位的临床有意义的变化。然而，目前的研究包括比较从基线到几个月后的即时变化，在初步研究中涉及更多的变异，SD为16而不是10。对于7个单位的变化，使用40个受试者的中心，通过双侧测试，在5%的水平上发现显著变化的能力将达到80%。我们计划在每个网站招收50名受试者，目标是保留至少40名受试者，除了项目的质量外，还包括时间和旅行补偿。对于主要终点分析，将采用普通(即最小二乘)多元回归分析，以中心分层，并使用二元指示变量调整协变量进行处理。主要目标的另一个方面涉及评估3个月和6个月的后续行动是否有任何改善。对个人的改变也将用于此：从基线改变即刻生效，以及从课程结束时改变3个月和6个月的后续影响。我们预计这一研究项目需要48个月：启动试验需要12个月，包括集中的工作人员培训和清洗StepWatch活动监测员，24个月全面登记研究，另外6个月完成试验，6个月完成结果分析。关键工作人员需要 薪金支助将由协查员、四名现场协调员、四名咨询多发性硬化症护士和四名多发性硬化症物理或职业咨询治疗师(每个地点各一名)提供。在这项研究的四年中，预算估计为116万美元。

DESCRIPTION (provided by applicant): The purpose of this research project is to determine if Fatigue: Take Control (FTC), a formal multi-modal program owned and distributed by the National Multiple Sclerosis (MS) Society (NMSS) based on the Fatigue and MS clinical practice guideline, is effective in reducing fatigue in Veterans and others with MS. The specific objectives are: 1) To determine if FTC reduces fatigue in non-depressed ambulatory people with MS at the end of the intervention and at 3, 6 and 12 months after the intervention compared to a general MS group education program on the Modified Fatigue Impact Scale, the primary outcome measure; 2) To determine if FTC increases self-efficacy compared to a general MS group education program in people with MS as measured by the MS Self-Efficacy Scale; 3) To determine if FTC results in subjects reporting a) changes in medication utilization using a self-report medication diary, b) exercise participatio using the self-report Rapid Assessment of Physical Activity and c) quality of life using the SF-36, and 4) To determine if FTC objectively increases activity participation compared to a general MS group education program using the StepWatch Activity Monitors (SAM). 200 subjects will be enrolled (100 per arm) with 50 at each of four VA sites - Portland, Seattle, Baltimore and Gainesville - for a randomized single blind controlled parallel treatment trial with two arms. It i important to conduct this trial at a minimum of 4 sites to establish that the program is effective t different locations, with different moderators, with an appropriate control intervention to control for socialization and content, and to ensure rapid enrollment. Subjects will be randomized to participate either in the FTC (includes DVD viewing, discussion, homework and workbooks) or a general MS education program not addressing fatigue (includes discussion and NMSS produced materials). Subjects will attend weekly two-hour group classes for 6 weeks with primary outcome data collected at baseline and one week after completing the classes. At 3 months and 6 months following completion of their respective programs, subjects will undergo repeat evaluations to assess for durability of responses and then will exit the study. Subjects wil be recruited from the VA MS Clinics, the MS Clinics at the affiliated medical schools and the community to assure participation of women and minorities. The SD of difference from baseline MFIS in the pilot study was about 10. This means that groups of about 40 each would provide power of 80% for detecting the clinically meaningful change of 7 units. However, the present study involves comparison of the immediate change from baseline to that several months later, involving more variation with a SD in the pilot study of 16 rather than 10. Power for detecting change of 7 units, using centers of 40 subjects each will provide 80% power of finding significant change at the 5% level with a 2-sided test. We plan to enroll 50 subjects at each site with the goal of retaining at least 40 with reimbursement for time and travel in addition to the quality of the programs. For the primary endpoint analysis, ordinary (i.e. least squares) multiple regression analysis will be employed, stratifying on center, and adjusting for covariates using a binary indicator variable for treatment. The other aspect of the primary aim involves assessing maintenance of any improvement in follow-ups at 3 and 6 months. Changes for individuals will also be used for this: change from baseline for the immediate effect, and change from the end of course for the follow-up effects at 3 and 6 months. We anticipate requiring 48 months for this research project: 12 months to initiate the trial including centralized staff training and purchasig the StepWatch Activity Monitors, 24 months to fully enroll the study, six additional months to complete the trial and six months to complete analysis of the results. The critical staff requiring salary support will be the Co-Investigator, four Site Coordinators, four consulting MS nurses and four consulting MS physical or occupational therapists (one each at each site). The estimated budget will be $1,160,000 over the four years of the study.