Balfour Medical Centre
Penticton, British Columbia, V2A 4Z1, Canada
NCT Number: NCT03270449
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.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Penticton, British Columbia, V2A 4Z1, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10 week multidisciplinary education and exercise
Time frame: 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
Time frame: 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
Time frame: Change from baseline in daily function at 10 weeks and 6 months
Mental health related functioning as measured by Hospital Anxiety and Depression scale
Time frame: Change from baseline in physician visits at 6 months
Number of physician visits
Time frame: Change from baseline in emergency department visits at 6 months
Number of emergency department visits
Time frame: Change from baseline in sleep quality at 10 weeks
Quality of sleep as measured by Sleep scale - medical outcome scale
Time frame: Change from baseline in sleep quality at 6 months
Quality of sleep as measured by Sleep scale - medical outcome scale
Time frame: Change from baseline in pain attitudes at 10 weeks and 6 months
Measurement of pain through Survey of brief attitudes of pain
Time frame: Change from baseline in irritability at 10 weeks
Irritability measured by Brief Irritability Test (BITe) questionnaire
Time frame: Change from baseline in irritability at 6 months
Irritability measured by Brief Irritability Test (BITe) questionnaire
Time frame: 10 weeks
Questionnaire to be administered to gather patient perspectives on self-management resources offered via hard copy, online, and social media
Time frame: 6 months
Questionnaire to be administered to gather patient perspectives on self-management resources offered via hard copy, online, and social media
Time frame: 18 months
Interviews will be conducted to gather providers' perspectives on the model of care
University of British Columbia
Other
A Multi-disciplinary, Community-based Group Intervention for Fibromyalgia: A Pilot Randomized Controlled Trial
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