NCT02203084|Completed
Social Determinants in Chronic Disease in British Columbia
The Influence of Social Determinants and Access to Health Care on the Outcome of Children With Chronic Health Problems in British Columbia
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The Influence of Social Determinants and Access to Health Care on the Outcome of Children With Chronic Health Problems in British Columbia
Sponsor study identifier
observational
300
1 country
1
Study Start
September 1, 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 1, 2017
Actual (reported)Study Completion
August 1, 2017
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 25, 2014
Actual (reported)July 29, 2014
Actual (reported)September 1, 2014
Date type not reportedThis date has not been verified as actual or estimated.
June 1, 2017
Actual (reported)August 1, 2017
Actual (reported)Level of glycosylated hemoglobin (HbA1C)
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.
1 year
Height/weight
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.
1 year
Lung Function Tests
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.
The questionnaire contains a general background information section common to all medical conditions. It then contains separate sections with medical condition specific questions.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
BC's Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
Schechter MS, Shelton BJ, Margolis PA, Fitzsimmons SC. The association of socioeconomic status with outcomes in cystic fibrosis patients in the United States. Am J Respir Crit Care Med. 2001 May;163(6):1331-7. doi: 10.1164/ajrccm.163.6.9912100.
Taylor-Robinson DC, Smyth RL, Diggle PJ, Whitehead M. The effect of social deprivation on clinical outcomes and the use of treatments in the UK cystic fibrosis population: a longitudinal study. Lancet Respir Med. 2013 Apr;1(2):121-8. doi: 10.1016/S2213-2600(13)70002-X. Epub 2013 Jan 30.
Mike Seear, MD
British Columbia's Children's Hospital
Mike Seear, MD
BCCH
First Submitted
July 25, 2014
First Posted
July 29, 2014
Study Start
September 1, 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 1, 2017
Choline Nutrition in Children With Cystic Fibrosis (CF)
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.
1 year
Glomerular filtration rate (GFR)
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.
1 year
Albumin/creatinine ratio
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.
1 year
Contact the study team to confirm eligibility.
Secrest AM, Costacou T, Gutelius B, Miller RG, Songer TJ, Orchard TJ. Associations between socioeconomic status and major complications in type 1 diabetes: the Pittsburgh epidemiology of diabetes complication (EDC) Study. Ann Epidemiol. 2011 May;21(5):374-81. doi: 10.1016/j.annepidem.2011.02.007.
Carter PJ, Cutfield WS, Hofman PL, Gunn AJ, Wilson DA, Reed PW, Jefferies C. Ethnicity and social deprivation independently influence metabolic control in children with type 1 diabetes. Diabetologia. 2008 Oct;51(10):1835-42. doi: 10.1007/s00125-008-1106-9. Epub 2008 Aug 5.
Hidalgo G, Ng DK, Moxey-Mims M, Minnick ML, Blydt-Hansen T, Warady BA, Furth SL. Association of income level with kidney disease severity and progression among children and adolescents with CKD: a report from the Chronic Kidney Disease in Children (CKiD) Study. Am J Kidney Dis. 2013 Dec;62(6):1087-94. doi: 10.1053/j.ajkd.2013.06.013. Epub 2013 Aug 7.
Gao S, Manns BJ, Culleton BF, Tonelli M, Quan H, Crowshoe L, Ghali WA, Svenson LW, Hemmelgarn BR; Alberta Kidney Disease Network. Prevalence of chronic kidney disease and survival among aboriginal people. J Am Soc Nephrol. 2007 Nov;18(11):2953-9. doi: 10.1681/ASN.2007030360. Epub 2007 Oct 17.
Bulloch B, Postl BD, Ogborn MR. Excess prevalence of non diabetic renal disease in native American children in Manitoba. Pediatr Nephrol. 1996 Dec;10(6):702-4. doi: 10.1007/s004670050193.
Gao S, Manns BJ, Culleton BF, Tonelli M, Quan H, Crowshoe L, Ghali WA, Svenson LW, Ahmed S, Hemmelgarn BR; Alberta Kidney Disease Network. Access to health care among status Aboriginal people with chronic kidney disease. CMAJ. 2008 Nov 4;179(10):1007-12. doi: 10.1503/cmaj.080063.
Samuel SM, Foster BJ, Hemmelgarn BR, Nettel-Aguirre A, Crowshoe L, Alexander RT, Soo A, Tonelli MA; Pediatric Renal Outcomes Canada Group. Incidence and causes of end-stage renal disease among Aboriginal children and young adults. CMAJ. 2012 Oct 2;184(14):E758-64. doi: 10.1503/cmaj.120427. Epub 2012 Aug 27.
Yeates K. Health disparities in renal disease in Canada. Semin Nephrol. 2010 Jan;30(1):12-8. doi: 10.1016/j.semnephrol.2009.10.014.
Study Completion
August 1, 2017
Actual (reported)Last Updated
September 21, 2017
Record last verified: 2017-09
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