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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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).


Sponsor: University Medical Center Groningen

Current Primary Outcome:

  • Subjective general health Status on the Clinical Global Improvement scale [ Time Frame: 3 months ]
    CGI, self-rated, 7-point scale of general health status
  • Subjective general health Status on the Clinical Global Improvement scale [ Time Frame: 6 months ]
    CGI self-rated, 7-point scale of general health status


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life on domains of RAND-36 [ Time Frame: 3 months ]
    extra question added to RAND-36 from WHOQuality Of Life scale
  • Quality of life on domains of RAND-36 [ Time Frame: 6 months ]
    extra question added to RAND-36 from WHO-Quality Of Life scale
  • 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
  • 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
  • Referral and other treatments on a questionnaire about referral and other treatments [ Time Frame: 6 months ]
    Questions about future and past referrals to treatment
  • Symptom severity on the change in presenting symptoms scale [ Time Frame: 3 months ]
  • Symptom severity on the change in presenting symptoms scale [ Time Frame: 6 months ]
  • Work and social adjustment [ Time Frame: 6 months ]
    Work and Social Adjustment scale
  • 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
  • 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
  • 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
  • Psychiatric outcome on the Patient Health Questionnaire [ Time Frame: 6 months ]
  • Fatigue on CIS-fatigue scale [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: University Medical Center Groningen

Dates:
Date Received: October 2, 2015
Date Started: October 2015
Date Completion: August 2017
Last Updated: May 10, 2016
Last Verified: May 2016