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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Functional Motor Disorder

Intervention / Treatment
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* Other: Education and self-help internet intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention<br>This arm will receive the education and self-help internet intervention added to usual care | Other: Education and self-help internet intervention<br>* 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.<br>|
| No Intervention: control<br>This arm will receive usual care only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective general health Status on the Clinical Global Improvement scale | CGI, self-rated, 7-point scale of general health status | 3 months | 
| Subjective general health Status on the Clinical Global Improvement scale | CGI self-rated, 7-point scale of general health status | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life on domains of RAND-36 | extra question added to RAND-36 from WHOQuality Of Life scale | 3 months | 
| Quality of life on domains of RAND-36 | extra question added to RAND-36 from WHO-Quality Of Life scale | 6 months | 
| Illness beliefs on the Illness Perception Questionnaire | 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 | 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 | Questions about future and past referrals to treatment | 6 months | 
| Symptom severity on the change in presenting symptoms scale |  | 3 months | 
| Symptom severity on the change in presenting symptoms scale |  | 6 months | 
| Work and social adjustment | Work and Social Adjustment scale | 6 months | 
| Cost-effectivity in QALY's calculated by using the PCQ, MCQ and EQ5D | Analysis using: Patient Costs Questionnaire, Medical Costs Questionnaire, and EQ5D | 6 months | 
| Patient satisfaction with general care and the study intervention | 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 | Questions on satisfaction with general care and with the education and selfhelp intervention in particular | 6 months | 
| Psychiatric outcome on the Patient Health Questionnaire |  | 6 months | 
| Fatigue on CIS-fatigue scale |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-help, Education, e-Health