此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Self-help and Education on the Internet for Functional Motor Disorders (SHIFT)

2019年1月28日 更新者:Marina de Koning-Tijssen、University Medical Center Groningen

Self-Help and Education on the Internet for Functional Motor Disorders, a Randomised Controlled Trial (SHIFT)

A randomised trial to the effect of a newly developed education and self help intervention for patients with a functional motor disorder on general health, quality of life, illness perception, symptom severity and other secondary outcome measures.

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

介入性

注册 (实际的)

189

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Groningen、荷兰、9700 RB
        • University Medical Center Groningen

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
有源比较器:intervention
This arm will receive the education and self-help internet intervention added to usual care
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.
无干预:control
This arm will receive usual care only

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
Subjective general health Status on the Clinical Global Improvement scale
大体时间:3 months
CGI, self-rated, 7-point scale of general health status
3 months
Subjective general health Status on the Clinical Global Improvement scale
大体时间:6 months
CGI self-rated, 7-point scale of general health status
6 months

次要结果测量

结果测量
措施说明
大体时间
Quality of life on domains of RAND-36
大体时间:3 months
extra question added to RAND-36 from WHOQuality Of Life scale
3 months
Quality of life on domains of RAND-36
大体时间:6 months
extra question added to RAND-36 from WHO-Quality Of Life scale
6 months
Illness beliefs on the Illness Perception Questionnaire
大体时间:3 months
Questions from the Illness Perception Questionnaire and newly devised questions about beliefs and understanding of functional motor disorders
3 months
Illness beliefs on the Illness Perception Questionnaire
大体时间:6 months
Questions from the Illness Perception Questionnaire and newly devised questions about beliefs and understanding of functional motor disorders
6 months
Referral and other treatments on a questionnaire about referral and other treatments
大体时间:6 months
Questions about future and past referrals to treatment
6 months
Symptom severity on the change in presenting symptoms scale
大体时间:3 months
3 months
Symptom severity on the change in presenting symptoms scale
大体时间:6 months
6 months
Work and social adjustment
大体时间:6 months
Work and Social Adjustment scale
6 months
Cost-effectivity in QALY's calculated by using the PCQ, MCQ and EQ5D
大体时间:6 months
Analysis using: Patient Costs Questionnaire, Medical Costs Questionnaire, and EQ5D
6 months
Patient satisfaction with general care and the study intervention
大体时间:3 months
Questions on satisfaction with general care and with the education and selfhelp intervention in particular
3 months
Patient satisfaction with general care and the study intervention
大体时间:6 months
Questions on satisfaction with general care and with the education and selfhelp intervention in particular
6 months
Psychiatric outcome on the Patient Health Questionnaire
大体时间:6 months
6 months
Fatigue on CIS-fatigue scale
大体时间:6 months
6 months

其他结果措施

结果测量
措施说明
大体时间
Adverse events
大体时间:6 months
Death and hospitalization during the trial
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年10月1日

初级完成 (实际的)

2018年12月1日

研究完成 (实际的)

2018年12月1日

研究注册日期

首次提交

2015年10月2日

首先提交符合 QC 标准的

2015年10月26日

首次发布 (估计)

2015年10月28日

研究记录更新

最后更新发布 (实际的)

2019年1月29日

上次提交的符合 QC 标准的更新

2019年1月28日

最后验证

2019年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • METc/2015/141

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅