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

28. januar 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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).

Studietype

Intervensjonell

Registrering (Faktiske)

189

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: intervention
This arm will receive the education and self-help internet intervention added to usual care
Annen: 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 inngripen: control
This arm will receive usual care only

Hva måler studien?

Primære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Medical Center Groningen

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2015

Primær fullføring (Faktiske)

1. desember 2018

Studiet fullført (Faktiske)

1. desember 2018

Datoer for studieregistrering

Først innsendt

2. oktober 2015

Først innsendt som oppfylte QC-kriteriene

26. oktober 2015

Først lagt ut (Anslag)

28. oktober 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. januar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. januar 2019

Sist bekreftet

1. januar 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • METc/2015/141

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

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