Community-based Intervention for Fibromyalgia: A Pilot Trial

NCT03270449 | Completed

• 1 other identifier: H17-01782
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; community-based; multidisciplinary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Daily function #1

  Change from baseline in daily function at 10 weeks and 6 months

• Daily function #2

  Change from baseline in daily function at 10 weeks and 6 months

• Health care utilization (physician visits)

  Change from baseline in physician visits at 6 months

• Health care utilization (emergency visits)

  Change from baseline in emergency department visits at 6 months

Other Outcomes (8)

• Sleep quality

  Change from baseline in sleep quality at 10 weeks

• Sleep quality

  Change from baseline in sleep quality at 6 months

• Attitudes of pain

  Change from baseline in pain attitudes at 10 weeks and 6 months

Study Arms (2)

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.

Other: Multidisciplinary intervention

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.

Interventions

Multidisciplinary intervention OTHER

10 week multidisciplinary education and exercise

Multidisciplinary intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Rheumatology Association: collaborator
• Interior Health: collaborator

Study Sites (1)

Balfour Medical Centre

Penticton, British Columbia, V2A 4Z1, Canada

Location

Related Publications (14)

• 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.

  PMID: 23748251 BACKGROUND

• 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.

  PMID: 21859448 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.

  PMID: 20393262 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.

  PMID: 20975520 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.

  PMID: 21332254 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.

  PMID: 23213512 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.

  PMID: 23597377 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.

  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.

  PMID: 15838407 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.

  PMID: 19664287 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.

  PMID: 23995734 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.

  PMID: 19185539 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.

  PMID: 9150298 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Michelle Teo

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: September 1, 2017
• Study Start: September 15, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: October 9, 2019

Record last verified: 2019-10

Locations

CA (1)