FibromyalgiaNCT03409653
Complex Chronic Diseases Program Data Registry
An observational study of Fibromyalgia and Chronic Fatigue Syndrome, run by BC Women's Hospital & Health Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
- How many people
- 1,300 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jun 2017to 30 Sep 2025
- How long will I take part?
- 21 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Newly referred patients of the Complex Chronic Diseases Program
- Must be able to read and understand English
- 18 years of age or older
Who cannot join
- Have not completed the Standardized Questionnaires booklet prior to the initial intake assessment.
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Women's Hospital + Health Centre
Vancouver, British Columbia, V6H 3N1
About this study
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.
Read the detailed description
- 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.
- Conditions
- Fibromyalgia, Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Chronic Lyme-Like Syndrome
- Keywords
- fatigue, pain, chronic pain, Data registry, ME/CFS, CFS, FM, Post-exertional malaise, Lyme
- Medical subject headings
- Fibromyalgia, Fatigue Syndrome, Chronic, Fatigue, Pain, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life
Change in self-reported quality of life assessed by structured questionnaire (36 Item Short Form Health Survey (SF-36))
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start12 Jun 2017
- Primary completion30 Sep 2022
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
- Target duration
- 21 Months
Sponsor and investigators
- Lead sponsor
- BC Women's Hospital & Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, British Columbia
- Responsible party
- Principal investigator, Luis Nacul, BC Women's Hospital & Health Centre
- Investigators
- Luis C Nacul, MD, Principal investigator, Medical Director CCDP, Complex Chronic Care ClinicWee-Shian Chan, MD, Study chair, Department Head, Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409653
- Sponsor's protocol ID
- H16-01648
- Status last verified
- Feb 2023
- First submitted
- 30 Nov 2017
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Chronic Diseases Program Data Registry
- ClinicalTrials.gov ID
- NCT03409653
- Acronym / sponsor ID
- H16-01648
- Conditions
- Fibromyalgia, Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Chronic Lyme-Like Syndrome
- Keywords
- fatigue, pain, chronic pain, Data registry, ME/CFS, CFS, FM, Post-exertional malaise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- BC Women's Hospital & Health CentreUniversity, hospital or other
- Collaborators
- Ministry of Health, British Columbia
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 21 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Newly referred patients of the Complex Chronic Diseases Program
- Must be able to read and understand English
- 18 years of age or older
Key exclusion criteria (1 listed)
- Have not completed the Standardized Questionnaires booklet prior to the initial intake assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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))
6 secondary outcomes
Brief Pain Inventory Short Form (BPI-SF)
Time frame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
Fatigue Severity Scale (FSS)
Time frame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
McGill Pain Questionnaire Short Form
Time frame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
Patient Health Questionnaire 9 (PHQ - 9)
Time frame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
Generalized Anxiety Disorder - 7 item (GAD - 7)
Time frame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis C Nacul, MD principal investigator
Medical Director CCDP, Complex Chronic Care Clinic
Wee-Shian Chan, MD study chair
Department Head, Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Chronic Fatigue Syndrome, run by BC Women's Hospital & Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life (time frame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.