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Completed

NCT Number: NCT02589886

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

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.

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Key information

Conditions

Functional Motor Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education and self-help internet intervention

Other

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.

Primary outcomes

  1. Subjective general health Status on the Clinical Global Improvement scale

    Time frame: 3 months

    CGI, self-rated, 7-point scale of general health status

  2. Subjective general health Status on the Clinical Global Improvement scale

    Time frame: 6 months

    CGI self-rated, 7-point scale of general health status

Secondary outcomes

  1. Quality of life on domains of RAND-36

    Time frame: 3 months

    extra question added to RAND-36 from WHOQuality Of Life scale

  2. Quality of life on domains of RAND-36

    Time frame: 6 months

    extra question added to RAND-36 from WHO-Quality Of Life scale

  3. Illness beliefs on the Illness Perception Questionnaire

    Time frame: 3 months

    Questions from the Illness Perception Questionnaire and newly devised questions about beliefs and understanding of functional motor disorders

  4. Illness beliefs on the Illness Perception Questionnaire

    Time frame: 6 months

    Questions from the Illness Perception Questionnaire and newly devised questions about beliefs and understanding of functional motor disorders

  5. Referral and other treatments on a questionnaire about referral and other treatments

    Time frame: 6 months

    Questions about future and past referrals to treatment

  6. Symptom severity on the change in presenting symptoms scale

    Time frame: 3 months

  7. Symptom severity on the change in presenting symptoms scale

    Time frame: 6 months

  8. Work and social adjustment

    Time frame: 6 months

    Work and Social Adjustment scale

  9. Cost-effectivity in QALY's calculated by using the PCQ, MCQ and EQ5D

    Time frame: 6 months

    Analysis using: Patient Costs Questionnaire, Medical Costs Questionnaire, and EQ5D

  10. Patient satisfaction with general care and the study intervention

    Time frame: 3 months

    Questions on satisfaction with general care and with the education and selfhelp intervention in particular

  11. Patient satisfaction with general care and the study intervention

    Time frame: 6 months

    Questions on satisfaction with general care and with the education and selfhelp intervention in particular

  12. Psychiatric outcome on the Patient Health Questionnaire

    Time frame: 6 months

  13. Fatigue on CIS-fatigue scale

    Time frame: 6 months

Other outcomes

  1. Adverse events

    Time frame: 6 months

    Death and hospitalization during the trial

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: SHIFT

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 28, 2015
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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