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Trial record 17 of 125 for:    fibromyalgia | Recruiting, Not yet recruiting, Available Studies

Community-based Intervention for Fibromyalgia: A Pilot Trial

This study is not yet open for participant recruitment.
Verified August 2017 by Nelly Oelke, University of British Columbia
Sponsor:
ClinicalTrials.gov Identifier:
NCT03270449
First Posted: September 1, 2017
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Canadian Rheumatology Association
Interior Health
Information provided by (Responsible Party):
Nelly Oelke, University of British Columbia
  Purpose
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 Intervention
Fibromyalgia Other: Multidisciplinary intervention

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Nelly Oelke, University of British Columbia:

Primary Outcome Measures:
  • Patient-perceived quality of care [ Time Frame: Change from baseline in perceived quality of care at 10 weeks ]
    Patient assessment of care received as measured by the Patient Assessment of Chronic Illness Care Questionnaire

  • Patient-perceived quality of care [ Time Frame: Change from baseline in perceived quality of care at 6 months ]
    Patient assessment of care received as measured by the Patient Assessment of Chronic Illness Care Questionnaire


Secondary Outcome Measures:
  • Daily function [ Time Frame: Change from baseline in daily function at 10 weeks ]
    Physical disease and mental health related functioning as measured by Revised-Fibromyalgia Impact Questionnaire

  • Daily function [ Time Frame: Change from baseline in daily function at 10 weeks ]
    Mental health related functioning as measured by Hospital Anxiety and Depression scale

  • Daily function [ Time Frame: Change from baseline in daily function at 6 months ]
    Physical disease and mental health related functioning as measured by Revised-Fibromyalgia Impact Questionnaire

  • Daily function [ Time Frame: Change from baseline in daily function at 6 months ]
    Mental health related functioning as measured by Hospital Anxiety and Depression scale

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

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

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

  • Pain [ Time Frame: Change from baseline in pain attitudes at 10 weeks ]
    Measurement of pain through Survey of brief attitudes of pain

  • Pain [ Time Frame: Change from baselinle in pain attitudes at 6 months ]
    Measurement of pain through Survey of brief attitudes of pain

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

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

  • 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

  • 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

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


Estimated Enrollment: 84
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Nelly Oelke 250-807-9880 nelly.oelke@ubc.ca
Contact: Michelle Teo 778-476-8046 mteo@balfourmed.com

Sponsors and Collaborators
University of British Columbia
Canadian Rheumatology Association
Interior Health
Investigators
Principal Investigator: Michelle Teo University of British Columbia
  More Information

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 Submitted: August 21, 2017
First Posted: September 1, 2017
Last Update Posted: September 1, 2017
Last Verified: August 2017

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