Self-help and Education on the Internet for Functional Motor Disorders (SHIFT)
Self-Help and Education on the Internet for Functional Motor Disorders, a Randomised Controlled Trial (SHIFT)
研究概览
详细说明
Patients will be referred to the study from all neurology centers in the Netherlands that are found willing to participate. After informed consent is acquired, patients will be randomised into one of these two groups: usual care only or the education and self help intervention added to usual care. At baseline, after 3 months and after 6 months patients will fill out questionnaires at home online or on paper.
Patients will not be blinded for the intervention. The researcher is blinded during analysis of the data. During the study contact between the researcher and the participants will be restricted to research related topics. All contact between participants and the researcher will be documented.
To increase generalisability and applicability in clinical practice after the trial the investigators have chosen to add the intervention to usual care and to keep exclusion criteria to a minimum.
Our education and self help internet intervention is an especially designed website with an educational approach. The content of the intervention is written by a team of international experts and consists of education about the mechanism of functional motor disorders and it's treatment and of self help advice and exercises. During the trial the website will only be accessible with a log-in. The education and self help internet intervention is self-explanatory and unguided.
The medical ethical committee of the University Medical Center Groningen has taken our research under review and has decided this study does not fall under the scope of the Medical Research Involving Human Subjects Act (WMO-Wet Mensgebonden Onderzoek).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Groningen、荷兰、9700 RB
- University Medical Center Groningen
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosis of functional motor symptom from a neurologist
- The motor symptom(s) cause(s) distress or impairment in social, occupational or other important areas of functioning.
- Able to read Dutch
- Access to a computer with internet connection on a regular basis
Exclusion Criteria:
- Incapacitated (Not able to provide informed consent)
- Accidental finding of a motor symptom in a patient with other (functional) complaints.
- Known existing visitor of the (previously available, but currently offline) translated version of a website by Dr. Jon Stone
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:intervention
This arm will receive the education and self-help internet intervention added to usual care
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The intervention is a newly developed website which consists of information about the mechanism and treatment of functional motor disorders.
Furthermore self-help elements like exercises to perform at home and rehabilitation advice are added.
The intervention is unguided.
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无干预:control
This arm will receive usual care only
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Subjective general health Status on the Clinical Global Improvement scale
大体时间:3 months
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CGI, self-rated, 7-point scale of general health status
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3 months
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Subjective general health Status on the Clinical Global Improvement scale
大体时间:6 months
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CGI self-rated, 7-point scale of general health status
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of life on domains of RAND-36
大体时间:3 months
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extra question added to RAND-36 from WHOQuality Of Life scale
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3 months
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Quality of life on domains of RAND-36
大体时间:6 months
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extra question added to RAND-36 from WHO-Quality Of Life scale
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6 months
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Illness beliefs on the Illness Perception Questionnaire
大体时间:3 months
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Questions from the Illness Perception Questionnaire and newly devised questions about beliefs and understanding of functional motor disorders
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3 months
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Illness beliefs on the Illness Perception Questionnaire
大体时间:6 months
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Questions from the Illness Perception Questionnaire and newly devised questions about beliefs and understanding of functional motor disorders
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6 months
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Referral and other treatments on a questionnaire about referral and other treatments
大体时间:6 months
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Questions about future and past referrals to treatment
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6 months
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Symptom severity on the change in presenting symptoms scale
大体时间:3 months
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3 months
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Symptom severity on the change in presenting symptoms scale
大体时间:6 months
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6 months
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Work and social adjustment
大体时间:6 months
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Work and Social Adjustment scale
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6 months
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Cost-effectivity in QALY's calculated by using the PCQ, MCQ and EQ5D
大体时间:6 months
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Analysis using: Patient Costs Questionnaire, Medical Costs Questionnaire, and EQ5D
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6 months
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Patient satisfaction with general care and the study intervention
大体时间:3 months
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Questions on satisfaction with general care and with the education and selfhelp intervention in particular
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3 months
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Patient satisfaction with general care and the study intervention
大体时间:6 months
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Questions on satisfaction with general care and with the education and selfhelp intervention in particular
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6 months
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Psychiatric outcome on the Patient Health Questionnaire
大体时间:6 months
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6 months
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Fatigue on CIS-fatigue scale
大体时间:6 months
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6 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Adverse events
大体时间:6 months
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Death and hospitalization during the trial
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6 months
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合作者和调查者
调查人员
- 首席研究员:Marina Tijssen, MD, PhD、University Medical Center Groningen, University of Groningen
出版物和有用的链接
一般刊物
- Sharpe M, Walker J, Williams C, Stone J, Cavanagh J, Murray G, Butcher I, Duncan R, Smith S, Carson A. Guided self-help for functional (psychogenic) symptoms: a randomized controlled efficacy trial. Neurology. 2011 Aug 9;77(6):564-72. doi: 10.1212/WNL.0b013e318228c0c7. Epub 2011 Jul 27.
- Lehn A, Gelauff J, Hoeritzauer I, Ludwig L, McWhirter L, Williams S, Gardiner P, Carson A, Stone J. Functional neurological disorders: mechanisms and treatment. J Neurol. 2016 Mar;263(3):611-20. doi: 10.1007/s00415-015-7893-2. Epub 2015 Sep 26.
- Stone J, Carson A. Functional neurologic disorders. Continuum (Minneap Minn). 2015 Jun;21(3 Behavioral Neurology and Neuropsychiatry):818-37. doi: 10.1212/01.CON.0000466669.02477.45.
- Gelauff JM, Dreissen YE, Tijssen MA, Stone J. Treatment of functional motor disorders. Curr Treat Options Neurol. 2014 Apr;16(4):286. doi: 10.1007/s11940-014-0286-5.
- Gelauff JM, Rosmalen JGM, Carson A, Dijk JM, Ekkel M, Nielsen G, Stone J, Tijssen MAJ. Internet-based self-help randomized trial for motor functional neurologic disorder (SHIFT). Neurology. 2020 Sep 29;95(13):e1883-e1896. doi: 10.1212/WNL.0000000000010381. Epub 2020 Jul 20.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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