Complex Chronic Diseases Program Data Registry

Fibromyalgia Clinical Trial

Official title:

Complex Chronic Diseases Program Data Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03409653
• Other study ID #: H16-01648
• Status: Enrolling by invitation
• Start date: June 12, 2017
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2023
• Source: BC Women's Hospital & Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1300
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Fatigue Syndrome
• Chronic Lyme-Like Syndrome
• Encephalomyelitis
• Fatigue
• Fatigue Syndrome, Chronic
• Fibromyalgia
• Myalgic Encephalomyelitis
• Syndrome

Locations

Country	Name	City	State
Canada	BC Women's Hospital + Health Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
BC Women's Hospital & Health Centre	Ministry of Health, Province of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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