Complex Chronic Diseases Program Data Registry

NCT ID: NCT03409653

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-12
• Study Completion Date: 2025-09-30

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.

Conditions

Fibromyalgia; Chronic Fatigue Syndrome; Myalgic Encephalomyelitis; Chronic Lyme-Like Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Province of British Columbia

UNKNOWN

Sponsor Role: collaborator

BC Women's Hospital & Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Luis Nacul

Medical Director CCDP, Complex Chronic Care Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luis C Nacul, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Director CCDP, Complex Chronic Care Clinic

Wee-Shian Chan, MD

Role: STUDY_CHAIR

Department Head, Medicine

Locations

BC Women's Hospital + Health Centre

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H16-01648

Identifier Type: -

Identifier Source: org_study_id