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Community-based Intervention for Fibromyalgia: A Pilot Trial

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ClinicalTrials.gov Identifier: NCT03270449
Recruitment Status : Active, not recruiting
First Posted : September 1, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Canadian Rheumatology Association
Interior Health
Information provided by (Responsible Party):
Nelly Oelke, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Multidisciplinary intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Multi-disciplinary, Community-based Group Intervention for Fibromyalgia: A Pilot Randomized Controlled Trial
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: Multidisciplinary intervention
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
10 week multidisciplinary education and exercise

No Intervention: Usual care
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.



Primary Outcome Measures :
  1. Patient-perceived quality of care [ 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


Secondary Outcome Measures :
  1. Daily function #1 [ 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

  2. Daily function #2 [ 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

  3. Health care utilization (physician visits) [ Time Frame: Change from baseline in physician visits at 6 months ]
    Number of physician visits

  4. Health care utilization (emergency visits) [ Time Frame: Change from baseline in emergency department visits at 6 months ]
    Number of emergency department visits


Other Outcome Measures:
  1. Sleep quality [ Time Frame: Change from baseline in sleep quality at 10 weeks ]
    Quality of sleep as measured by Sleep scale - medical outcome scale

  2. Sleep quality [ Time Frame: Change from baseline in sleep quality at 6 months ]
    Quality of sleep as measured by Sleep scale - medical outcome scale

  3. Attitudes of pain [ Time Frame: Change from baseline in pain attitudes at 10 weeks and 6 months ]
    Measurement of pain through Survey of brief attitudes of pain

  4. Irritability [ Time Frame: Change from baseline in irritability at 10 weeks ]
    Irritability measured by Brief Irritability Test (BITe) questionnaire

  5. Irritability [ Time Frame: Change from baseline in irritability at 6 months ]
    Irritability measured by Brief Irritability Test (BITe) questionnaire

  6. Patient perspectives on self-management resources [ Time Frame: 10 weeks ]
    Questionnaire to be administered to gather patient perspectives on self-management resources offered via hard copy, online, and social media

  7. Patient perspectives on self-management resources [ Time Frame: 6 months ]
    Questionnaire to be administered to gather patient perspectives on self-management resources offered via hard copy, online, and social media

  8. Provider perspectives on quality of care [ Time Frame: 18 months ]
    Interviews will be conducted to gather providers' perspectives on the model of care



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270449


Locations
Canada, British Columbia
Balfour Medical Centre
Penticton, British Columbia, Canada, V2A 4Z1
Sponsors and Collaborators
University of British Columbia
Canadian Rheumatology Association
Interior Health
Investigators
Principal Investigator: Michelle Teo University of British Columbia

Publications:
Richards L, Morse J. Read me first for a users guide to qualitative methods. (3rd ed.) Sage Publications, Inc. 2013.
Verbeke G, Molenberghs G. Linear mixed models for longitudinal data. Springer Science & Business Media; 2009.

Responsible Party: Nelly Oelke, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03270449     History of Changes
Other Study ID Numbers: H17-01782
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

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

Keywords provided by Nelly Oelke, University of British Columbia:
fibromyalgia
community-based
multidisciplinary

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases