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临床试验/NCT00591721
NCT00591721已完成不适用

Effectiveness of a Teleconference Delivered Fatigue Management Program for People With Multiple Sclerosis

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
190
试验地点
2
主要终点
Change From Baseline in Subscale Scores of the Fatigue Impact Scale

研究概览

简要总结

Approximately 60% of individuals with multiple sclerosis (MS) describe fatigue as their most disabling symptom. Energy conservation education involves teaching people with MS different strategies to manage fatigue and reduce its impact on daily life. Despite growing evidence of the effectiveness of face-to-face energy conservation education, not all people with MS are able to access these programs. The purpose of this project is to test the effectiveness and efficacy of a teleconference-delivered energy conservation education program for people with MS. The primary goals of the project are to reduce the impact of fatigue on participants' everyday lives, reduce fatigue severity, and improve quality of life. Secondary goals are to increase self-efficacy for managing fatigue and increase the number of energy conservation strategies used. The study will employ a randomly allocated two group time series design with a wait-list control group, which is one type of randomized control trial. A total of 181 people with MS will be recruited through direct mailing and advertising. The program will be delivered by telephone teleconference by a licensed occupational therapist. Outcome measures will be administered over the telephone by a research assistant before and after the program, at three months and at six months. We hypothesize that: (1) individuals in the immediate intervention group achieve better outcomes than individuals in the wait-list control group; (2) the program leads to significant reductions in fatigue impact and fatigue severity, and improved quality of life; and (3) improvements in the outcomes can be maintained over six months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a diagnosis of MS
  • 18 years of age or older
  • functional English literacy (i.e., able to read course materials and carry on telephone conservations in English)
  • Fatigue Severity Scale score of 4 or greater
  • Residing in the state of Illinois

排除标准

  • Short version - Blessed Orientation Memory Concentration Test - outside of normal range

结局指标

主要结局

Change From Baseline in Subscale Scores of the Fatigue Impact Scale

时间窗: baseline, 7 weeks (immediate post-intervention)

Fatigue impact was measured using the "Fatigue Impact Scale (FIS)" (Fisk et al, 1994). This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rate each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score (range from 0 to 160) and three subscale scores (physical - 10 items, score range 0 to 40; psychosocial - 20 items, score range 0 to 80; cognitive - 10 items, score range 0-40) can be produced from participants' responses. Higher scores reflect greater fatigue impact. What is reported here is the mean individual differences in the 7 week post subscale scores minus the baseline subscale scores

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcia Finlayson, PhD

Professor

University of Illinois at Chicago

研究点 (2)

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