An observational study in Fibromyalgia, Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, sponsored by BC Women's Hospital & Health Centre. Enrolling by invitation at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by BC Women's Hospital & Health Centre · Observational
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.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 1,300 is above the median of 100 across 279 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →BC Women's Hospital & Health Centre is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Change in quality of life
Change in self-reported quality of life assessed by structured questionnaire (36 Item Short Form Health Survey (SF-36))
Time frame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2017 to primary completion in Sep 2022, 63 months.
Of 81 non-industry observational studies under Fibromyalgia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 109. This study's 63 months is above that.
Counting every sponsor, half of 88 studies reached it within 27 months; a quarter within 8 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
BC Women's Hospital & Health Centre