Complex Chronic Diseases Program Data Registry

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Fibromyalgia; Chronic Fatigue Syndrome; Myalgic Encephalomyelitis; Chronic Lyme-Like Syndrome

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.

• Study Type: Observational
• Enrollment (Anticipated): 1300

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • BC Women's Hospital + Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	Change in self-reported quality of life assessed by structured questionnaire (36 Item Short Form Health Survey (SF-36))	Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory Short Form (BPI-SF)	The BPI-SF is a self-reported standard questionnaire used to evaluate the severity of pain and the impact of this pain on the patient's daily functioning.	Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
Fatigue Severity Scale (FSS)	The FSS is a self-reported standard questionnaire that uses a scale to measures the severity of the fatigue and its effect on a person's activities and lifestyles in patients with a variety of disorders. It uses a 7- point Liker scale, where 1=Strongly Disagree and 7= Strongly agree. Score range is 1-7. Higher schore indicates more severe fatigue.	Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
McGill Pain Questionnaire Short Form	The McGill Pain Questionnaire Short Form is self-reported standard questionnaire. It is used to describes the subjective overall intensity of the total pain experience.	Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
Pittsburgh Sleep Quality Index (PSQI)	The PSQI is a self-reported standard questionnaires. It is used to assess sleep quality and disturbances.	Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
Patient Health Questionnaire 9 (PHQ - 9)	The PHQ-9 is a self-reported standard questionnaire used to screen, diagnose, monitor and measure the severity of depression.	Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
Generalized Anxiety Disorder - 7 item (GAD - 7)	The GAD-7 is a self-reported standard questionnaire used to measures the severity of various signs of general anxiety disorder according to response categories with assigned points.	Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge

Collaborators and Investigators

• Sponsor: BC Women's Hospital & Health Centre
• Collaborators: Ministry of Health, Province of British Columbia
• Investigators: Principal Investigator: Luis C Nacul, MD, Medical Director CCDP, Complex Chronic Care Clinic; Study Chair: Wee-Shian Chan, MD, Department Head, Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2017
• Primary Completion (ACTUAL): September 30, 2022
• Study Completion (ANTICIPATED): September 30, 2025

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (ACTUAL): January 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: chronic pain; pain; fatigue; CFS; Lyme; ME/CFS; FM; Data registry; Post-exertional malaise
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Disease Attributes; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Central Nervous System Infections; Syndrome; Fatigue; Fibromyalgia; Chronic Disease; Fatigue Syndrome, Chronic; Encephalomyelitis
• Other Study ID Numbers: H16-01648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No