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| Name | Class |
|---|---|
| Canadian Rheumatology Association | OTHER |
| Interior Health | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multidisciplinary intervention | Experimental | 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. |
|
| Usual care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidisciplinary intervention | Other | 10 week multidisciplinary education and exercise |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality | Quality of sleep as measured by Sleep scale - medical outcome scale | Change from baseline in sleep quality at 10 weeks |
| Sleep quality | Quality of sleep as measured by Sleep scale - medical outcome scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Teo | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balfour Medical Centre | Penticton | British Columbia | V2A 4Z1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23748251 | Background | Fitzcharles MA, Ste-Marie PA, Goldenberg DL, Pereira JX, Abbey S, Choiniere M, Ko G, Moulin DE, Panopalis P, Proulx J, Shir Y; National Fibromyalgia Guideline Advisory Panel. 2012 Canadian Guidelines for the diagnosis and management of fibromyalgia syndrome: executive summary. Pain Res Manag. 2013 May-Jun;18(3):119-26. doi: 10.1155/2013/918216. | |
| 21859448 |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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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 |
| Change from baseline in sleep quality at 6 months |
| Attitudes of pain | Measurement of pain through Survey of brief attitudes of pain | Change from baseline in pain attitudes at 10 weeks and 6 months |
| Irritability | Irritability measured by Brief Irritability Test (BITe) questionnaire | Change from baseline in irritability at 10 weeks |
| Irritability | Irritability measured by Brief Irritability Test (BITe) questionnaire | Change from baseline in irritability at 6 months |
| Patient perspectives on self-management resources | Questionnaire to be administered to gather patient perspectives on self-management resources offered via hard copy, online, and social media | 10 weeks |
| Patient perspectives on self-management resources | Questionnaire to be administered to gather patient perspectives on self-management resources offered via hard copy, online, and social media | 6 months |
| Provider perspectives on quality of care | Interviews will be conducted to gather providers' perspectives on the model of care | 18 months |
| Schaefer C, Chandran A, Hufstader M, Baik R, McNett M, Goldenberg D, Gerwin R, Zlateva G. The comparative burden of mild, moderate and severe fibromyalgia: results from a cross-sectional survey in the United States. Health Qual Life Outcomes. 2011 Aug 22;9:71. doi: 10.1186/1477-7525-9-71. |
| 20393262 | Background | Lachaine J, Beauchemin C, Landry PA. Clinical and economic characteristics of patients with fibromyalgia syndrome. Clin J Pain. 2010 May;26(4):284-90. doi: 10.1097/AJP.0b013e3181cf599f. |
| 20975520 | Background | Thompson JM, Luedtke CA, Oh TH, Shah ND, Long KH, King S, Branda M, Swanson R. Direct medical costs in patients with fibromyalgia: Cost of illness and impact of a brief multidisciplinary treatment program. Am J Phys Med Rehabil. 2011 Jan;90(1):40-6. doi: 10.1097/PHM.0b013e3181fc7ff3. |
| 21332254 | Background | Winkelmann A, Perrot S, Schaefer C, Ryan K, Chandran A, Sadosky A, Zlateva G. Impact of fibromyalgia severity on health economic costs: results from a European cross-sectional study. Appl Health Econ Health Policy. 2011 Mar 1;9(2):125-36. doi: 10.2165/11535250-000000000-00000. |
| 23213512 | Background | Bellato E, Marini E, Castoldi F, Barbasetti N, Mattei L, Bonasia DE, Blonna D. Fibromyalgia syndrome: etiology, pathogenesis, diagnosis, and treatment. Pain Res Treat. 2012;2012:426130. doi: 10.1155/2012/426130. Epub 2012 Nov 4. |
| 23597377 | Background | Gaglio B, Shoup JA, Glasgow RE. The RE-AIM framework: a systematic review of use over time. Am J Public Health. 2013 Jun;103(6):e38-46. doi: 10.2105/AJPH.2013.301299. Epub 2013 Apr 18. |
| Background | Richards L, Morse J. Read me first for a users guide to qualitative methods. (3rd ed.) Sage Publications, Inc. 2013. |
| Background | Verbeke G, Molenberghs G. Linear mixed models for longitudinal data. Springer Science & Business Media; 2009. |
| 15838407 | Background | Glasgow RE, Wagner EH, Schaefer J, Mahoney LD, Reid RJ, Greene SM. Development and validation of the Patient Assessment of Chronic Illness Care (PACIC). Med Care. 2005 May;43(5):436-44. doi: 10.1097/01.mlr.0000160375.47920.8c. |
| 19664287 | Background | Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10. |
| 23995734 | Background | Nam S, Tin D, Bain L, Thorne JC, Ginsburg L. Clinical utility of the Hospital Anxiety and Depression Scale (HADS) for an outpatient fibromyalgia education program. Clin Rheumatol. 2014 May;33(5):685-92. doi: 10.1007/s10067-013-2377-1. Epub 2013 Sep 1. |
| 19185539 | Background | Cappelleri JC, Bushmakin AG, McDermott AM, Dukes E, Sadosky A, Petrie CD, Martin S. Measurement properties of the Medical Outcomes Study Sleep Scale in patients with fibromyalgia. Sleep Med. 2009 Aug;10(7):766-70. doi: 10.1016/j.sleep.2008.09.004. Epub 2009 Jan 29. |
| 9150298 | Background | Tait RC, Chibnall JT. Development of a brief version of the Survey of Pain Attitudes. Pain. 1997 Apr;70(2-3):229-35. doi: 10.1016/s0304-3959(97)03330-7. |
| D009422 |
| Nervous System Diseases |