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

针对多发性硬化症疲劳的正式团体计划的随机试验

• 批准号: 8959938
• 负责人: Dennis Neil Bourdette
• 金额: --
• 依托单位: PORTLAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-10-01 至 2016-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8959938
• 关键词: Address; Affect; American; Baltimore; Budgets; Caring; Clinic; Clinical Practice Guideline; Communities; Community Health; Consult; Country; Data; Education; Effectiveness; Enrollment; Ensure; Evaluation; Evidence based treatment; Exercise; Family; Fatigue; Goals; Guidelines; Hour; Individual; Information Management; Intervention; Language; Least-Squares Analysis; Life; Location; Maintenance; Measures; Minority; Modeling; Monitor; Multiple Sclerosis; Nature; Neuraxis; Nurses; Occupational Therapist; Outcome Measure; Participant; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Physical activity; Pilot Projects; Practice Guidelines; Publishing; Quality of life; Randomized; Randomized Clinical Trials; Recommendation; Recruitment Activity; Regression Analysis; Reporting; Research; Research Personnel; Research Project Grants; SF-36; Self Efficacy; Series; Services; Side; Single-Blind Study; Site; Socialization; Societies; Structure; Symptoms; Testing; Time; Training; Travel; Variant; Veterans; Wages; Woman; arm; base; clinical practice; cost; cost effective; diaries; disabling disease; follow-up; health administration; health related quality of life; improved; innovation; medical schools; novel; pilot trial; primary outcome; programs; randomized trial; response; social; treatment trial; trial design

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.

描述（由申请人提供）： 该研究项目的目的是确定“疲劳：控制”(FTC) 是否能有效减少退伍军人和其他多发性硬化症患者的疲劳，疲劳：控制 (FTC) 是由国家多发性硬化症 (MS) 协会 (NMSS) 根据疲劳和多发性硬化症临床实践指南拥有和分发的正式多模式计划。具体目标是： 1) 确定 FTC 是否能在干预结束时以及干预后 3、6 和 12 个月时减轻患有多发性硬化症的非抑郁型卧床患者的疲劳，与修改疲劳影响量表（主要结果指标）上的一般多发性硬化症团体教育计划相比； 2) 确定与一般 MS 团体教育计划相比，FTC 是否可以提高 MS 患者的自我效能感（通过 MS 自我效能量表衡量）； 3) 确定 FTC 是否导致受试者报告 a) 使用自我报告用药日记的药物利用变化，b) 使用自我报告的身体活动快速评估的运动参与度和 c) 使用 SF-36 的生活质量， 4) 确定与使用 StepWatch 活动监视器 (SAM) 的一般 MS 团体教育计划相比，FTC 是否客观地提高了活动参与度。将招募 200 名受试者（每组 100 名），其中 4 个 VA 站点（波特兰、西雅图、巴尔的摩和盖恩斯维尔）各招募 50 名受试者，进行两组随机单盲对照平行治疗试验。重要的是要在至少 4 个地点进行这项试验，以确定该计划在不同地点、不同主持人和适当的控制干预下是有效的 社会化和内容，并确保快速入学。受试者将被随机分配参加 FTC（包括 DVD 观看、讨论、家庭作业和练习册）或不涉及疲劳的普通 MS 教育计划（包括讨论和 NMSS 制作的材料）。受试者将参加为期 6 周的每周两小时的小组课程，并在基线和完成课程后一周收集主要结果数据。在完成各自的项目后 3 个月和 6 个月，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 VA MS 诊所、附属医学院的 MS 诊所和社区招募，以确保妇女和少数族裔的参与。试点研究中与基线 MFIS 的差异标准差约为 10。这意味着每组约 40 人，可提供 80% 的功效来检测 7 个单位的临床有意义的变化。然而，本研究涉及从基线到几个月后的即时变化的比较，在试点研究中涉及 16 个而不是 10 个 SD 的更多变化。检测 7 个单位变化的功效，每个中心使用 40 个受试者，将提供 80% 的功效，通过 2 侧测试发现 5% 水平的显着变化。我们计划在每个站点招收 50 名受试者，目标是保留至少 40 名受试者，除了课程质量外，还提供时间和差旅费报销。对于主要终点分析，将采用普通（即最小二乘）多元回归分析，在中心分层，并使用治疗的二元指示变量调整协变量。主要目标的另一方面涉及评估 3 个月和 6 个月随访中任何改善的维持情况。个人的变化也将用于此目的：从基线的变化表示立即效果，从课程结束时的变化表示 3 个月和 6 个月的后续效果。我们预计该研究项目需要 48 个月的时间：12 个月启动试验，包括集中员工培训和购买 StepWatch 活动监视器，24 个月完全注册研究，另外 6 个月完成试验，6 个月完成结果分析。关键人员需要 薪资支持将由联合研究者、四名现场协调员、四名咨询 MS 护士和四名咨询 MS 物理或职业治疗师（每个中心各一名）提供。研究四年的预计预算为 1,160,000 美元。