Community-based Intervention for Fibromyalgia: A Pilot Trial

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270449
• Other study ID #: H17-01782
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: October 2019
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Multidisciplinary intervention
10 week multidisciplinary education and exercise

Locations

Country	Name	City	State
Canada	Balfour Medical Centre	Penticton	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Rheumatology Association, Interior Health

Country where clinical trial is conducted

Canada, 

References & Publications (14)

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. Erratum in: Pain Res Treat. 2013;2013:960270. — View Citation

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. Erratum in: Arthritis Res Ther. 2009;11(5):415. — View Citation

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. — View Citation

Fitzcharles MA, Ste-Marie PA, Goldenberg DL, Pereira JX, Abbey S, Choinière 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Richards L, Morse J. Read me first for a users guide to qualitative methods. (3rd ed.) Sage Publications, Inc. 2013.

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. — View Citation

Tait RC, Chibnall JT. Development of a brief version of the Survey of Pain Attitudes. Pain. 1997 Apr;70(2-3):229-35. — View Citation

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. — View Citation

Verbeke G, Molenberghs G. Linear mixed models for longitudinal data. Springer Science & Business Media; 2009.

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep quality	Quality of sleep as measured by Sleep scale - medical outcome scale	Change from baseline in sleep quality at 10 weeks
Other	Sleep quality	Quality of sleep as measured by Sleep scale - medical outcome scale	Change from baseline in sleep quality at 6 months
Other	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
Other	Irritability	Irritability measured by Brief Irritability Test (BITe) questionnaire	Change from baseline in irritability at 10 weeks
Other	Irritability	Irritability measured by Brief Irritability Test (BITe) questionnaire	Change from baseline in irritability at 6 months
Other	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
Other	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
Other	Provider perspectives on quality of care	Interviews will be conducted to gather providers' perspectives on the model of care	18 months
Primary	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	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
Secondary	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
Secondary	Health care utilization (physician visits)	Number of physician visits	Change from baseline in physician visits at 6 months
Secondary	Health care utilization (emergency visits)	Number of emergency department visits	Change from baseline in emergency department visits at 6 months