Community-based Intervention for Fibromyalgia: A Pilot Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Multidisciplinary intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multidisciplinary intervention<br>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. | Other: Multidisciplinary intervention<br>* 10 week multidisciplinary education and exercise<br>|
| No Intervention: Usual care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-perceived quality of care | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily function #1 | 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 | 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) | Number of physician visits | Change from baseline in physician visits at 6 months | 
| Health care utilization (emergency visits) | Number of emergency department visits | Change from baseline in emergency department visits at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibromyalgia, community-based, multidisciplinary