Clinical trial NCT03409653: Complex Chronic Diseases Program Data Registry
Official title: Complex Chronic Diseases Program Data Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Fibromyalgia
Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
Chronic Lyme-Like Syndrome
Keywords: fatigue
pain
chronic pain
Data registry
ME/CFS
CFS
FM
Post-exertional malaise
Lyme
Lead sponsor: BC Women's Hospital & Health Centre
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Province of British Columbia
First posted: 2018-01-24
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the Complex Chronic Diseases Program at BC Women's Hospital + Health Centre all have signs, symptoms or a diagnosis of: Fibromyalgia (FM), Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (ME/CFS), and/or Chronic Lyme-Like Syndrome (CLLS).

The factors involved in causing all three of these diseases are not well understood (Jain et al. 2003, Wolfe et al. 2010, Carruthers et al. 2003). Furthermore, symptoms, severity of symptoms and the effects of all of these complex chronic diseases can vary greatly among people with the same diagnosis.

All of these conditions are currently diagnosed according to the particular group of symptoms described by the patient.

Brief summary: The purpose of this data registry is to prospectively collect data from patients referred to an Complex Chronic Diseases Program (CCDP) at BC Women's Hospital + Health Centre to assess the quality of life of the CCDP Patients before, during and after their care at the CCDP.

Detailed description: 1. Before their initial intake appointment, all CCDP patients are given a patient binder that includes the baseline Standardized Questionnaires. These are clinical questionnaires that all patients complete regardless of whether or not they consent to participation in research. In addition to the questionnaires completed at baseline, patients who consent to participate in the data registry will complete the questionnaires, via email or paper copy, at the following time points: approximately 6 months after intake, at discharge and 3 months post-discharge.
2. Patients who consent to the data registry will also be asked to complete a short questionnaire collecting basic demographic information at baseline. The demographic questionnaire will be either mailed to their home or sent via an online link; the investigators will ask participants to complete this form either before or when they come in for their first in-person visit at the CCDP.
3. Additional data will be collected and entered from the clinical chart. Specifically, after the patient's initial clinic appointment, the Research Coordinator or designate will enter data points from the Interdisciplinary Assessment Tool, into REDCap.

Eligibility criteria: Inclusion Criteria:

* Newly referred patients of the Complex Chronic Diseases Program
* Must be able to read and understand English
* 18 years of age or older

Exclusion Criteria:

* Have not completed the Standardized Questionnaires booklet prior to the initial intake assessment.

Primary outcomes:
measure: Change in quality of life
timeFrame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
Secondary outcomes:
measure: Brief Pain Inventory Short Form (BPI-SF)
timeFrame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
measure: Fatigue Severity Scale (FSS)
timeFrame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
measure: McGill Pain Questionnaire Short Form
timeFrame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
measure: Patient Health Questionnaire 9 (PHQ - 9)
timeFrame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
measure: Generalized Anxiety Disorder - 7 item (GAD - 7)
timeFrame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital + Health Centre
state: British Columbia
Study officials:
affiliation: Medical Director CCDP, Complex Chronic Care Clinic
name: Luis C Nacul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department Head, Medicine
name: Wee-Shian Chan, MD
role: STUDY_CHAIR
References: