search
Back to results

Community-based Intervention for Fibromyalgia: A Pilot Trial

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Multidisciplinary intervention
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Fibromyalgia focused on measuring fibromyalgia, community-based, multidisciplinary

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Balfour Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multidisciplinary intervention

Usual care

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Patient-perceived quality of care
Patient assessment of care received as measured by the Patient Assessment of Chronic Illness Care Questionnaire

Secondary Outcome Measures

Daily function #1
Physical disease and mental health related functioning as measured by Revised-Fibromyalgia Impact Questionnaire
Daily function #2
Mental health related functioning as measured by Hospital Anxiety and Depression scale
Health care utilization (physician visits)
Number of physician visits
Health care utilization (emergency visits)
Number of emergency department visits

Full Information

First Posted
August 21, 2017
Last Updated
October 7, 2019
Sponsor
University of British Columbia
Collaborators
Canadian Rheumatology Association, Interior Health
search

1. Study Identification

Unique Protocol Identification Number
NCT03270449
Brief Title
Community-based Intervention for Fibromyalgia: A Pilot Trial
Official Title
A Multi-disciplinary, Community-based Group Intervention for Fibromyalgia: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Rheumatology Association, Interior Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, community-based, multidisciplinary

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multidisciplinary intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Multidisciplinary intervention
Intervention Description
10 week multidisciplinary education and exercise
Primary Outcome Measure Information:
Title
Patient-perceived quality of care
Description
Patient assessment of care received as measured by the Patient Assessment of Chronic Illness Care Questionnaire
Time Frame
Change from baseline in perceived quality of care at 10 weeks and 6 months
Secondary Outcome Measure Information:
Title
Daily function #1
Description
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
Title
Daily function #2
Description
Mental health related functioning as measured by Hospital Anxiety and Depression scale
Time Frame
Change from baseline in daily function at 10 weeks and 6 months
Title
Health care utilization (physician visits)
Description
Number of physician visits
Time Frame
Change from baseline in physician visits at 6 months
Title
Health care utilization (emergency visits)
Description
Number of emergency department visits
Time Frame
Change from baseline in emergency department visits at 6 months
Other Pre-specified Outcome Measures:
Title
Sleep quality
Description
Quality of sleep as measured by Sleep scale - medical outcome scale
Time Frame
Change from baseline in sleep quality at 10 weeks
Title
Sleep quality
Description
Quality of sleep as measured by Sleep scale - medical outcome scale
Time Frame
Change from baseline in sleep quality at 6 months
Title
Attitudes of pain
Description
Measurement of pain through Survey of brief attitudes of pain
Time Frame
Change from baseline in pain attitudes at 10 weeks and 6 months
Title
Irritability
Description
Irritability measured by Brief Irritability Test (BITe) questionnaire
Time Frame
Change from baseline in irritability at 10 weeks
Title
Irritability
Description
Irritability measured by Brief Irritability Test (BITe) questionnaire
Time Frame
Change from baseline in irritability at 6 months
Title
Patient perspectives on self-management resources
Description
Questionnaire to be administered to gather patient perspectives on self-management resources offered via hard copy, online, and social media
Time Frame
10 weeks
Title
Patient perspectives on self-management resources
Description
Questionnaire to be administered to gather patient perspectives on self-management resources offered via hard copy, online, and social media
Time Frame
6 months
Title
Provider perspectives on quality of care
Description
Interviews will be conducted to gather providers' perspectives on the model of care
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Teo
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Balfour Medical Centre
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 4Z1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23748251
Citation
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.
Results Reference
background
PubMed Identifier
21859448
Citation
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.
Results Reference
background
PubMed Identifier
20393262
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.
Results Reference
background
PubMed Identifier
20975520
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.
Results Reference
background
PubMed Identifier
21332254
Citation
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.
Results Reference
background
PubMed Identifier
23213512
Citation
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.
Results Reference
background
PubMed Identifier
23597377
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.
Results Reference
background
Citation
Richards L, Morse J. Read me first for a users guide to qualitative methods. (3rd ed.) Sage Publications, Inc. 2013.
Results Reference
background
Citation
Verbeke G, Molenberghs G. Linear mixed models for longitudinal data. Springer Science & Business Media; 2009.
Results Reference
background
PubMed Identifier
15838407
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. doi: 10.1097/01.mlr.0000160375.47920.8c.
Results Reference
background
PubMed Identifier
19664287
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.
Results Reference
background
PubMed Identifier
23995734
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.
Results Reference
background
PubMed Identifier
19185539
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.
Results Reference
background
PubMed Identifier
9150298
Citation
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.
Results Reference
background

Learn more about this trial

Community-based Intervention for Fibromyalgia: A Pilot Trial

We'll reach out to this number within 24 hrs