Fibromyalgia
Conditions
Keywords
fibromyalgia, community-based, multidisciplinary
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.
Interventions
10 week multidisciplinary education and exercise
Sponsors
Canadian Rheumatology Association
Interior Health
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 (physician visits) | Change from baseline in physician visits at 6 months | Number of physician visits |
| Health care utilization (emergency visits) | Change from baseline in emergency department visits at 6 months | Number of emergency department visits |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality | Change from baseline in sleep quality at 10 weeks | Quality of sleep as measured by Sleep scale - medical outcome scale |
| Attitudes of pain | Change from baseline in pain attitudes at 10 weeks and 6 months | Measurement of pain through Survey of brief attitudes of pain |
| Irritability | Change from baseline in irritability at 10 weeks | Irritability measured by Brief Irritability Test (BITe) questionnaire |
| Patient perspectives on self-management resources | 10 weeks | Questionnaire to be administered to gather patient perspectives on self-management resources offered via hard copy, online, and social media |
| Provider perspectives on quality of care | 18 months | Interviews will be conducted to gather providers' perspectives on the model of care |
Countries
Canada
Outcome results
None listed