Clinical trial NCT03270449: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
community-based
multidisciplinary
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Rheumatology Association
name: Interior Health
First posted: 2017-09-01
Enrollment: 84
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Patient-perceived quality of care
timeFrame: Change from baseline in perceived quality of care at 10 weeks and 6 months
Secondary outcomes:
measure: Daily function #1
timeFrame: Change from baseline in daily function at 10 weeks and 6 months
measure: Daily function #2
timeFrame: Change from baseline in daily function at 10 weeks and 6 months
measure: Health care utilization (physician visits)
timeFrame: Change from baseline in physician visits at 6 months
measure: Health care utilization (emergency visits)
timeFrame: Change from baseline in emergency department visits at 6 months
Other outcomes:
measure: Sleep quality
timeFrame: Change from baseline in sleep quality at 10 weeks
measure: Sleep quality
timeFrame: Change from baseline in sleep quality at 6 months
measure: Attitudes of pain
timeFrame: Change from baseline in pain attitudes at 10 weeks and 6 months
measure: Irritability
timeFrame: Change from baseline in irritability at 10 weeks
measure: Irritability
timeFrame: Change from baseline in irritability at 6 months
measure: Patient perspectives on self-management resources
timeFrame: 10 weeks
measure: Patient perspectives on self-management resources
timeFrame: 6 months
measure: Provider perspectives on quality of care
timeFrame: 18 months
Locations:
city: Penticton
country: Canada
facility: Balfour Medical Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Michelle Teo
role: PRINCIPAL_INVESTIGATOR
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