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Completed

NCT Number: NCT03270449

Community-based Intervention for Fibromyalgia: A Pilot Trial

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balfour Medical Centre

Penticton, British Columbia, V2A 4Z1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multidisciplinary intervention

Other

10 week multidisciplinary education and exercise

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Rheumatology Association
  • Interior Health

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 1, 2017
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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