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Social Determinants in Chronic Disease in British Columbia

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ClinicalTrials.gov Identifier: NCT02203084
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Seear, University of British Columbia

Brief Summary:

Anyone who practices clinical medicine will understand that socially disadvantaged children will have worse health outcomes, no matter what the underlying condition might be. There is limited prospective data on the effects of social deprivation on children in BC and there is none concerning the effects of social deprivation on children with chronic diseases. In order to generate relevant data for those who manage children with chronic diseases in BC, the investigators wish to perform an observational study of the relationship between questionnaire-derived social variables and measured outcomes in children with cystic fibrosis, type 1 diabetes, and chronic kidney disease.

Our working hypothesis is that there is an association between social determinants of health (income, education, race) and health outcomes in children with cystic fibrosis, type 1 diabetes and chronic renal failure, that is independent of access to health care (assessed by distance to nearest specialty clinic and number of clinic visits in the last year).


Condition or disease Intervention/treatment
Cystic Fibrosis Diabetes Mellitus Type I Chronic Renal Insufficiency Other: Social Determinants Questionnaire

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: The Influence of Social Determinants and Access to Health Care on the Outcome of Children With Chronic Health Problems in British Columbia
Study Start Date : September 1, 2014
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : August 1, 2017


Group/Cohort Intervention/treatment
Children with Chronic Medical Conditions
The Social Determinants Questionnaire will be administered to the three groups of children with chronic diseases (cystic fibrosis, diabetes mellitus type I, or chronic renal insufficiency). The questionnaire questions will be asked by a research assistant. Each participant will have the same general and background information questions then will have questions specific to their chronic medical condition.
Other: Social Determinants Questionnaire
The questionnaire contains a general background information section common to all medical conditions. It then contains separate sections with medical condition specific questions.




Primary Outcome Measures :
  1. Level of glycosylated hemoglobin (HbA1C) [ Time Frame: 1 year ]
    The level of glycosylated hemoglobin (HbA1C) is the conventional measure of glycemic control and will be used to assess the diabetic group. Data is measured every 3-6 months and will be collected from previous clinic visits. Measurements performed routinely at clinic visits. The monitoring results will be recorded but the study does not require or involve any testing other than tests associated with routine clinical practice.

  2. Height/weight [ Time Frame: 1 year ]
    Height/weight used to assess cystic fibrosis patients. Measurements performed routinely at clinic visits. The monitoring results will be recorded but the study does not require or involve any testing other than tests associated with routine clinical practice.

  3. Lung Function Tests [ Time Frame: 1 year ]
    Lung function tests used to assess cystic fibrosis patients. Measurements performed routinely at clinic visits. The monitoring results will be recorded but the study does not require or involve any testing other than tests associated with routine clinical practice.

  4. Glomerular filtration rate (GFR) [ Time Frame: 1 year ]
    GFR used to assess renal failure patients. Measurements performed routinely at clinic visits. The monitoring results will be recorded but the study does not require or involve any testing other than tests associated with routine clinical practice.

  5. Albumin/creatinine ratio [ Time Frame: 1 year ]
    Albumin/creatinine ratio used to assess renal failure patients. Measurements performed routinely at clinic visits. The monitoring results will be recorded but the study does not require or involve any testing other than tests associated with routine clinical practice.



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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be sampled from the cystic fibrosis clinic (150) patients and the chronic kidney disease clinic (150 patients). For the larger type 1 diabetes clinic the sample will be purposefully stratified. Recruitment will be monitored to ensure adequate representation from all the health authorities in BC.
Criteria

Inclusion Criteria:

  • Any individual who attends British Columbia Children's Hospital Ambulatory clinics in the following areas: cystic fibrosis, chronic kidney disease, or type 1 diabetes

Exclusion Criteria:

  • Refusal to join the study
  • Acute Medical Instability

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): NCT02203084


Locations
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Canada, British Columbia
BC's Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Mike Seear, MD British Columbia's Children's Hospital
Principal Investigator: Mike Seear, MD BCCH
Publications:

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Responsible Party: Michael Seear, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02203084    
Other Study ID Numbers: H14-01278
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Keywords provided by Michael Seear, University of British Columbia:
Cystic Fibrosis
Diabetes Mellitus Type I
Chronic Renal Insufficiency
The influence of socioeconomic variables upon outcome in children with three chronic medical diseases.
Additional relevant MeSH terms:
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Cystic Fibrosis
Renal Insufficiency
Renal Insufficiency, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 1
Fibrosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Kidney Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases