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

U

University Medical Center Groningen (UMCG)

Status

Completed

Conditions

Functional Motor Disorder

Treatments

Other: Education and self-help internet intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02589886
METc/2015/141

Details and patient eligibility

About

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.

Full 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).

Enrollment

189 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

189 participants in 2 patient groups

intervention
Active Comparator group
Description:
This arm will receive the education and self-help internet intervention added to usual care
Treatment:
Other: Education and self-help internet intervention
control
No Intervention group
Description:
This arm will receive usual care only

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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