Complex Chronic Diseases Program Data Registry

Study Overview
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Brief Summary
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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
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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. 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. 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.

Official Title
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Complex Chronic Diseases Program Data Registry

Conditions
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Fibromyalgia, Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Chronic Lyme-Like Syndrome

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, pain, chronic pain, Data registry, ME/CFS, CFS, FM, Post-exertional malaise, Lyme