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

28. januar 2019 opdateret af: Marina de Koning-Tijssen, University Medical Center Groningen

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

189

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Holland
      • Groningen, Holland, 9700 RB
        • University Medical Center Groningen

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: intervention
This arm will receive the education and self-help internet intervention added to usual care
Andet: Education and self-help internet intervention
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.
Ingen indgriben: control
This arm will receive usual care only

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subjective general health Status on the Clinical Global Improvement scale
Tidsramme: 3 months
CGI, self-rated, 7-point scale of general health status
3 months
Subjective general health Status on the Clinical Global Improvement scale
Tidsramme: 6 months
CGI self-rated, 7-point scale of general health status
6 months

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse events
Tidsramme: 6 months
Death and hospitalization during the trial
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Medical Center Groningen

Efterforskere

  • Ledende efterforsker: Marina Tijssen, MD, PhD, University Medical Center Groningen, University of Groningen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2015

Primær færdiggørelse (Faktiske)

1. december 2018

Studieafslutning (Faktiske)

1. december 2018

Datoer for studieregistrering

Først indsendt

2. oktober 2015

Først indsendt, der opfyldte QC-kriterier

26. oktober 2015

Først opslået (Skøn)

28. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • METc/2015/141

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Funktionel motorisk lidelse

Kliniske forsøg med Education and self-help internet intervention

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cyprus

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner