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Community-based Intervention for Fibromyalgia: A Pilot Trial

NCT03270449 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2019-10-09

No results posted yet for this study

Summary

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.

Conditions

  • Fibromyalgia

Interventions

OTHER

Multidisciplinary intervention

10 week multidisciplinary education and exercise

Sponsors & Collaborators

  • Canadian Rheumatology Association

    collaborator OTHER

  • Interior Health

    collaborator INDUSTRY

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Michelle Teo · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03270449 on ClinicalTrials.gov