Complex Chronic Diseases Program Data Registry

• Conditions: Chronic Lyme-Like Syndrome; Chronic Fatigue Syndrome; Myalgic Encephalomyelitis; Fibromyalgia

• Registration Number: NCT03409653
• Lead Sponsor: BC Women's Hospital & Health Centre

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.

Study Timeline

• Study Start: 2017-06-12
• Study First Submitted: 2017-11-30
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-24
• Primary Completion: 2022-09-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fatigue Severity Scale (FSS)	Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge	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.
McGill Pain Questionnaire Short Form	Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge	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.
Brief Pain Inventory Short Form (BPI-SF)	Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge	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.
Pittsburgh Sleep Quality Index (PSQI)	Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge	The PSQI is a self-reported standard questionnaires. It is used to assess sleep quality and disturbances.
Patient Health Questionnaire 9 (PHQ - 9)	Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge	The PHQ-9 is a self-reported standard questionnaire used to screen, diagnose, monitor and measure the severity of depression.
Generalized Anxiety Disorder - 7 item (GAD - 7)	Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge	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.

Trial Locations

Locations (1)

BC Women's Hospital + Health Centre; 🇨🇦 Vancouver, British Columbia, Canada