ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 59 of 74 for:    lyme

Complex Chronic Diseases Program Data Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03409653
Recruitment Status : Enrolling by invitation
First Posted : January 24, 2018
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
Ministry of Health, Province of British Columbia
Information provided by (Responsible Party):
Wee-Shian Chan, BC Women's Hospital & Health Centre

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.

Condition or disease
Fibromyalgia Chronic Fatigue Syndrome Myalgic Encephalomyelitis Chronic Lyme-Like Syndrome

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.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 21 Months
Official Title: Complex Chronic Diseases Program Data Registry
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Brief Pain Inventory Short Form (BPI-SF) [ Time Frame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge ]
    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.

  2. Fatigue Severity Scale (FSS) [ Time Frame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge ]
    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.

  3. McGill Pain Questionnaire Short Form [ Time Frame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge ]
    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.

  4. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge ]
    The PSQI is a self-reported standard questionnaires. It is used to assess sleep quality and disturbances.

  5. Patient Health Questionnaire 9 (PHQ - 9) [ Time Frame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge ]
    The PHQ-9 is a self-reported standard questionnaire used to screen, diagnose, monitor and measure the severity of depression.

  6. Generalized Anxiety Disorder - 7 item (GAD - 7) [ Time Frame: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409653


Locations
Canada, British Columbia
BC Women's Hospital + Health Centre
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
BC Women's Hospital & Health Centre
Ministry of Health, Province of British Columbia

Responsible Party: Wee-Shian Chan, Head, Department of Medicine (BC Women's Hospital and Health Centre), BC Women's Hospital & Health Centre
ClinicalTrials.gov Identifier: NCT03409653     History of Changes
Other Study ID Numbers: H16-01648
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Fatigue
Fibromyalgia
Chronic Disease
Fatigue Syndrome, Chronic
Encephalomyelitis
Disease
Pathologic Processes
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Disease Attributes
Virus Diseases
Central Nervous System Diseases
Central Nervous System Infections