NCT03409653

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

5.3 years

First QC Date

November 30, 2017

Last Update Submit

February 6, 2023

Conditions

FibromyalgiaChronic Fatigue SyndromeMyalgic EncephalomyelitisChronic Lyme-Like Syndrome

Keywords

fatiguepainchronic painData registryME/CFSCFSFMPost-exertional malaiseLyme

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Brief Pain Inventory Short Form (BPI-SF)

    Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge

  • 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

  • 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

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of the Complex Chronic Diseases Program at BC Women's Hospital + Health Centre all have signs, symptoms or a diagnosis of: Fibromyalgia (FM), Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (ME/CFS), and/or Chronic Lyme-Like Syndrome (CLLS). The factors involved in causing all three of these diseases are not well understood (Jain et al. 2003, Wolfe et al. 2010, Carruthers et al. 2003). Furthermore, symptoms, severity of symptoms and the effects of all of these complex chronic diseases can vary greatly among people with the same diagnosis. All of these conditions are currently diagnosed according to the particular group of symptoms described by the patient.

You may qualify if:

  • Newly referred patients of the Complex Chronic Diseases Program
  • Must be able to read and understand English
  • years of age or older

You may not qualify if:

  • Have not completed the Standardized Questionnaires booklet prior to the initial intake assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital + Health Centre

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Conditions

FibromyalgiaFatigue Syndrome, ChronicFatiguePainChronic Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesEncephalomyelitisNeuroinflammatory DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurologic Manifestations

Study Officials

  • Luis C Nacul, MD

    Medical Director CCDP, Complex Chronic Care Clinic

    PRINCIPAL INVESTIGATOR

  • Wee-Shian Chan, MD

    Department Head, Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
21 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director CCDP, Complex Chronic Care Clinic

Study Record Dates

First Submitted

November 30, 2017

First Posted

January 24, 2018

Study Start

June 12, 2017

Primary Completion

September 30, 2022

Study Completion

September 30, 2025

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)