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Clinical Trials/NCT03409653
NCT03409653
Enrolling by Invitation
N/A

Complex Chronic Diseases Program Data Registry

BC Women's Hospital & Health Centre1 site in 1 country1,300 target enrollmentJune 12, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
BC Women's Hospital & Health Centre
Enrollment
1300
Locations
1
Primary Endpoint
Change in quality of life
Status
Enrolling by Invitation
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 12, 2017
End Date
September 30, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
BC Women's Hospital & Health Centre
Responsible Party
Principal Investigator
Principal Investigator

Luis Nacul

Medical Director CCDP, Complex Chronic Care Clinic

BC Women's Hospital & Health Centre

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.

Outcomes

Primary Outcomes

Change in quality of life

Time Frame: 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 Outcomes

  • Fatigue Severity Scale (FSS)(Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge)
  • McGill Pain Questionnaire Short Form(Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge)
  • Brief Pain Inventory Short Form (BPI-SF)(Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge)
  • Pittsburgh Sleep Quality Index (PSQI)(Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge)
  • Patient Health Questionnaire 9 (PHQ - 9)(Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge)
  • Generalized Anxiety Disorder - 7 item (GAD - 7)(Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge)

Study Sites (1)

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