Community-based Intervention for Fibromyalgia: A Pilot Trial

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: Multidisciplinary intervention

• Registration Number: NCT03270449
• Lead Sponsor: University of British Columbia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-01
• Study Start: 2017-09-15
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-07
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multidisciplinary intervention	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.

Primary Outcome Measures

Name	Time	Method
Patient-perceived quality of care	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

Secondary Outcome Measures

Name	Time	Method
Daily function #1	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
Health care utilization (physician visits)	Change from baseline in physician visits at 6 months	Number of physician visits
Daily function #2	Change from baseline in daily function at 10 weeks and 6 months	Mental health related functioning as measured by Hospital Anxiety and Depression scale
Health care utilization (emergency visits)	Change from baseline in emergency department visits at 6 months	Number of emergency department visits

Trial Locations

Locations (1)

Balfour Medical Centre; 🇨🇦 Penticton, British Columbia, Canada