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

Not Applicable

Completed

• Conditions: Functional Motor Disorder
• Interventions: Other: Education and self-help internet intervention

• Registration Number: NCT02589886
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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

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).

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-02
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-28
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Education and self-help internet intervention	This arm will receive the education and self-help internet intervention added to usual care

Primary Outcome Measures

Name	Time	Method
Subjective general health Status on the Clinical Global Improvement scale	6 months	CGI self-rated, 7-point scale of general health status

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands