Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Community-based Intervention for Fibromyalgia: A Pilot Trial

7. oktober 2019 opdateret af: Nelly Oelke, University of British Columbia

A Multi-disciplinary, Community-based Group Intervention for Fibromyalgia: A Pilot Randomized Controlled Trial

Fibromyalgia (FM) is a multi-factorial chronic pain condition characterized by fluctuating and heterogeneous symptoms. This leads to both reduced patient function and quality of life and consequentially, significant economic burden on the society. Although numerous pharmaceutical and multi-treatment approaches exist, there is lack of an integrated multidisciplinary model of care for these patients. Such a system is hypothesized to be beneficial for the patients and would help them regain function and significantly improve their quality of life. The primary aim of this pilot clinical trial is to evaluate the effectiveness of an integrated community-based multidisciplinary model of care for FM patients in Penticton and surrounding areas. The comprehensive 10 week intervention will provide care from a team of health care providers (psychiatrist, physiotherapist, certified exercise therapist, dietitian, rheumatologist, and mental health clinician). Patients will also attend a peer led pain self-management support group provided by the Arthritis Society. The study aims at educating these patients about self-management of their symptoms such as chronic pain, weight, sleep and mood disorders. The integration of health care between the different providers will be achieved by "huddle" sessions that will be conducted on a monthly basis. The evaluation of the study outcomes will be based on the RE-AIM framework. Data will be collected through patient questionnaires, healthcare utilization data, and interviews with providers. Data analysis will involve thematic analysis of qualitative data and statistical methods for quantitative data.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

84

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Canada
    • British Columbia
      • Penticton, British Columbia, Canada, V2A 4Z1
        • Balfour Medical Centre

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

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • formal diagnosis of FM
  • resident of Penticton or surrounding area
  • adults, aged 19 and older
  • fluent in English or bring a family member/friend to assist with translation
  • capacity to provide informed consent

Exclusion Criteria:

  • patients with a severe and/or chronic medical or psychiatric condition that would impact ability to participate in the intervention
  • patients who are pregnant or lactating

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Multidisciplinary intervention
The 10-week intervention will include twice weekly 1-2 hours sessions with multiple professional team members to undergo education and exercise sessions. The multidisciplinary team will consist of a rheumatologist, rheumatology nurse, dietitian, physiotherapist, a trained exercise therapist, a physiologist who specializes in pain management, a psychiatrist and a mental health clinician. All intervention team members have expertise in working with individuals with chronic pain conditions. General disease information, current best practices and techniques such as self-pain management, pacing, sleep hygiene, approach to a healthy lifestyle and weight loss will be discussed. The total number of hours for the 10 week intervention is 31 hours.
Andet: Multidisciplinary intervention
10 week multidisciplinary education and exercise
Ingen indgriben: Usual care
Usual care involves being referred to the local rheumatologist involved in the study. The rheumatologist and the rheumatology nurse will see the control group patients during a one hour one on one consultation appointment. During that time the patient's history will be taken, physical exam performed and investigations analyzed. If a diagnosis of fibromyalgia is confirmed, the rheumatologist and nurse will counsel the patient and provide resources for self directed management. Unless there is a concern of an alternative diagnosis, follow up will not be arranged.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient-perceived quality of care
Tidsramme: Change from baseline in perceived quality of care at 10 weeks and 6 months
Patient assessment of care received as measured by the Patient Assessment of Chronic Illness Care Questionnaire
Change from baseline in perceived quality of care at 10 weeks and 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Daily function #1
Tidsramme: Change from baseline in daily function at 10 weeks and 6 months
Physical disease and mental health related functioning as measured by Revised-Fibromyalgia Impact Questionnaire
Change from baseline in daily function at 10 weeks and 6 months
Daily function #2
Tidsramme: Change from baseline in daily function at 10 weeks and 6 months
Mental health related functioning as measured by Hospital Anxiety and Depression scale
Change from baseline in daily function at 10 weeks and 6 months
Health care utilization (physician visits)
Tidsramme: Change from baseline in physician visits at 6 months
Number of physician visits
Change from baseline in physician visits at 6 months
Health care utilization (emergency visits)
Tidsramme: Change from baseline in emergency department visits at 6 months
Number of emergency department visits
Change from baseline in emergency department visits at 6 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sleep quality
Tidsramme: Change from baseline in sleep quality at 10 weeks
Quality of sleep as measured by Sleep scale - medical outcome scale
Change from baseline in sleep quality at 10 weeks
Sleep quality
Tidsramme: Change from baseline in sleep quality at 6 months
Quality of sleep as measured by Sleep scale - medical outcome scale
Change from baseline in sleep quality at 6 months
Attitudes of pain
Tidsramme: Change from baseline in pain attitudes at 10 weeks and 6 months
Measurement of pain through Survey of brief attitudes of pain
Change from baseline in pain attitudes at 10 weeks and 6 months
Irritability
Tidsramme: Change from baseline in irritability at 10 weeks
Irritability measured by Brief Irritability Test (BITe) questionnaire
Change from baseline in irritability at 10 weeks
Irritability
Tidsramme: Change from baseline in irritability at 6 months
Irritability measured by Brief Irritability Test (BITe) questionnaire
Change from baseline in irritability at 6 months
Patient perspectives on self-management resources
Tidsramme: 10 weeks
Questionnaire to be administered to gather patient perspectives on self-management resources offered via hard copy, online, and social media
10 weeks
Patient perspectives on self-management resources
Tidsramme: 6 months
Questionnaire to be administered to gather patient perspectives on self-management resources offered via hard copy, online, and social media
6 months
Provider perspectives on quality of care
Tidsramme: 18 months
Interviews will be conducted to gather providers' perspectives on the model of care
18 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of British Columbia

Samarbejdspartnere

Interior Health
Canadian Rheumatology Association

Efterforskere

  • Ledende efterforsker: Michelle Teo, University of British Columbia

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 (Faktiske)

15. september 2017

Primær færdiggørelse (Faktiske)

30. juni 2019

Studieafslutning (Faktiske)

30. juni 2019

Datoer for studieregistrering

Først indsendt

21. august 2017

Først indsendt, der opfyldte QC-kriterier

31. august 2017

Først opslået (Faktiske)

1. september 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. oktober 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. oktober 2019

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H17-01782

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 Multidisciplinary intervention

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kenya

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner