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Community-based Intervention for Fibromyalgia: A Pilot Trial

7. oktober 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

84

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

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

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

19 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Multidisciplinary intervention
10 week multidisciplinary education and exercise
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

University of British Columbia

Samarbeidspartnere

Interior Health
Canadian Rheumatology Association

Etterforskere

  • Hovedetterforsker: Michelle Teo, University of British Columbia

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 (Faktiske)

15. september 2017

Primær fullføring (Faktiske)

30. juni 2019

Studiet fullført (Faktiske)

30. juni 2019

Datoer for studieregistrering

Først innsendt

21. august 2017

Først innsendt som oppfylte QC-kriteriene

31. august 2017

Først lagt ut (Faktiske)

1. september 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. oktober 2019

Sist bekreftet

1. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • H17-01782

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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