Self-Help and Education on the Internet for Functional Motor Disorders, a Randomised Controlled Trial (SHIFT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Subjective general health Status on the Clinical Global Improvement scale
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Subjective general health Status on the Clinical Global Improvement scale
时间窗: 6 months
CGI self-rated, 7-point scale of general health status
次要结局
- Fatigue on CIS-fatigue scale(6 months)
- Work and social adjustment(6 months)
- Psychiatric outcome on the Patient Health Questionnaire(6 months)
- Quality of life on domains of RAND-36(6 months)
- Referral and other treatments on a questionnaire about referral and other treatments(6 months)
- Illness beliefs on the Illness Perception Questionnaire(6 months)
- Cost-effectivity in QALY's calculated by using the PCQ, MCQ and EQ5D(6 months)
- Symptom severity on the change in presenting symptoms scale(6 months)
- Patient satisfaction with general care and the study intervention(6 months)
研究者
Marina de Koning-Tijssen
Prof. Dr. de Koning-Tijssen
University Medical Center Groningen