<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02203084</url>
  </required_header>
  <id_info>
    <org_study_id>H14-01278</org_study_id>
    <nct_id>NCT02203084</nct_id>
  </id_info>
  <brief_title>Social Determinants in Chronic Disease in British Columbia</brief_title>
  <official_title>The Influence of Social Determinants and Access to Health Care on the Outcome of Children With Chronic Health Problems in British Columbia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anyone who practices clinical medicine will understand that socially disadvantaged children&#xD;
      will have worse health outcomes, no matter what the underlying condition might be. There is&#xD;
      limited prospective data on the effects of social deprivation on children in BC and there is&#xD;
      none concerning the effects of social deprivation on children with chronic diseases. In order&#xD;
      to generate relevant data for those who manage children with chronic diseases in BC, the&#xD;
      investigators wish to perform an observational study of the relationship between&#xD;
      questionnaire-derived social variables and measured outcomes in children with cystic&#xD;
      fibrosis, type 1 diabetes, and chronic kidney disease.&#xD;
&#xD;
      Our working hypothesis is that there is an association between social determinants of health&#xD;
      (income, education, race) and health outcomes in children with cystic fibrosis, type 1&#xD;
      diabetes and chronic renal failure, that is independent of access to health care (assessed by&#xD;
      distance to nearest specialty clinic and number of clinic visits in the last year).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Cystic fibrosis (CF). Cystic fibrosis is a genetic condition that causes slowly&#xD;
           progressive lung disease. It occurs in people of all social class so the disease itself&#xD;
           is independent of social factors. There is considerable variation in the outcome of CF&#xD;
           in different children. There are many potential causes for these differences but the&#xD;
           available literature would suggest that a significant part of this variability is due to&#xD;
           social factors. While there are no prospective clinical studies, the limited information&#xD;
           from database reviews suggest that socially deprived children have significantly worse&#xD;
           outcomes. In the US, children living in poverty are twice as likely to be underweight&#xD;
           and over three times more likely to die (25). UK data is similar - disadvantaged&#xD;
           children have worse growth parameters and lower lung function compared to richer&#xD;
           children (26).&#xD;
&#xD;
        2. Type 1 diabetes (T1D). Type 1 diabetes is a multi-factorial disease. It is not an&#xD;
           autosomal recessive disease like CF but genetic predisposition can be one of its&#xD;
           predisposing features. As with the data on CF, socio-economic deprivation has been shown&#xD;
           to have a significant adverse effect on outcome in type 1 diabetes. In the US, glycemic&#xD;
           control amongst young adults was significantly worse amongst disadvantaged young adults&#xD;
           (27). A retrospective review of New Zealand children with type 1 diabetes also showed&#xD;
           that poor socio-economic status and Polynesian ethnicity were significantly associated&#xD;
           with poor glycemic control and long term complications (28).&#xD;
&#xD;
        3. Chronic kidney disease (CKD). Chronic kidney disease may be due to congenital, acquired,&#xD;
           or hereditary causes. Within all these groups, socioeconomic status, gender, and race&#xD;
           may influence disease progression and outcomes. It has been shown in children with&#xD;
           chronic kidney disease, primarily from the United States, that it was more common in&#xD;
           low- and middle- income families to have an abnormal birth history such as prematurity,&#xD;
           low birth weight or small for age which predisposes to the development of renal disease&#xD;
           (29). In addition, blood pressure control and height deficits improve faster in children&#xD;
           of families with higher income. In Canada, Aboriginals have a higher prevalence of&#xD;
           severe chronic kidney disease and a 77% increased mortality risk (30,31) and a lower&#xD;
           likelihood of nephrology clinic visits (32). Aboriginal children and young adults with&#xD;
           chronic kidney disease are more likely to have glomerulonephritis as a cause of kidney&#xD;
           disease compared to Caucasians and are more likely to reach end stage renal disease&#xD;
           (33). In contrast, lower mortality risks are seen in East Asian and Indo Asian Canadian&#xD;
           adults starting dialysis (34). There is still much to be studied on the influence of&#xD;
           these various factors in renal health and disease.&#xD;
&#xD;
      STUDY DESIGN.&#xD;
&#xD;
        1. Study Objective. We wish to determine the influence of education, income, race and&#xD;
           access to health care upon health outcomes in children with chronic diseases in British&#xD;
           Columbia.&#xD;
&#xD;
        2. Justification. While the effects of social deprivation on health outcomes are commonly&#xD;
           discussed, it is surprising how little prospective research there is to quantify the&#xD;
           adverse effects of social inequity. There is limited prospective data on the effects of&#xD;
           social deprivation on children in BC and there is none concerning the effects of social&#xD;
           deprivation on children with chronic diseases. In order to generate firm data relevant&#xD;
           for those who manage children with chronic diseases in BC, we wish to perform a cross&#xD;
           sectional observational study of the relationship between social variables and outcome&#xD;
           in children with cystic fibrosis, type 1 diabetes and chronic kidney disease.&#xD;
&#xD;
        3. General design. All families in the three clinics will initially be informed of the&#xD;
           study by letter. When the child is due for regular follow-up assessment, the parents&#xD;
           will be approached during the clinic visit and invited to join the study. Their&#xD;
           participation will only involve the completion of a questionnaire. The research&#xD;
           assistant will collect the data at interview and will subsequently (with parental&#xD;
           permission) retrieve laboratory results from records of previous clinic visits to assess&#xD;
           measured health trends over time. The study protocol does not add any further&#xD;
           investigations other than the questionnaire. Apart from the variable time needed for&#xD;
           parent information and consent, the questionnaire itself will require no more than about&#xD;
           30 minutes to complete.&#xD;
&#xD;
        4. Questionnaire. We will use a socio-economic assessment questions that we are already&#xD;
           using in our study of quality of life in parents caring for children needing home&#xD;
           ventilation. It is a conventional form assessing education level, employment, income,&#xD;
           partnership status and ethnicity. This last is very important because of the poorer&#xD;
           health outcomes already known to be associated with Aboriginal background. The proxy for&#xD;
           access to health care will be distance to the main specialty clinic and number of visits&#xD;
           in the last year.&#xD;
&#xD;
        5. Analysis. The relationship between socio-economic variables plus ethnicity and outcome&#xD;
           will be examined using multiple linear regression analysis. In the absence of relevant&#xD;
           literature, there are too many unknowns to allow any reliable form of power analysis or&#xD;
           patient number calculation to be performed. One accepted 'rule of thumb' is that there&#xD;
           should be at least 10 patients for each predictive variable in multiple linear&#xD;
           regression analysis. We will concentrate on 6 to 8 of the main social factors and will&#xD;
           try to enroll over 100 patients within each sub-specialty - enough to ensure 15 to 20&#xD;
           patient outcomes for each variable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 1, 2014</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">June 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Level of glycosylated hemoglobin (HbA1C)</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height/weight</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lung Function Tests</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glomerular filtration rate (GFR)</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Albumin/creatinine ratio</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Cystic Fibrosis</condition>
  <condition>Diabetes Mellitus Type I</condition>
  <condition>Chronic Renal Insufficiency</condition>
  <arm_group>
    <arm_group_label>Children with Chronic Medical Conditions</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Social Determinants Questionnaire</intervention_name>
    <description>The questionnaire contains a general background information section common to all medical conditions. It then contains separate sections with medical condition specific questions.</description>
    <arm_group_label>Children with Chronic Medical Conditions</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be sampled from the cystic fibrosis clinic (150) patients and the chronic&#xD;
        kidney disease clinic (150 patients). For the larger type 1 diabetes clinic the sample will&#xD;
        be purposefully stratified. Recruitment will be monitored to ensure adequate representation&#xD;
        from all the health authorities in BC.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any individual who attends British Columbia Children's Hospital Ambulatory clinics in&#xD;
             the following areas: cystic fibrosis, chronic kidney disease, or type 1 diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to join the study&#xD;
&#xD;
          -  Acute Medical Instability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mike Seear, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>British Columbia's Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mike Seear, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BCCH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BC's Children's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>11371397</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24429092</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21458731</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18679654</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23932090</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17942955</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8971883</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18981441</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22927509</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20116643</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Michael Seear</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Cystic Fibrosis</keyword>
  <keyword>Diabetes Mellitus Type I</keyword>
  <keyword>Chronic Renal Insufficiency</keyword>
  <keyword>The influence of socioeconomic variables upon outcome in children with three chronic medical diseases.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02203084
org study id: H14-01278
nct id: NCT02203084
lead sponsor: 
has dmc: No
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).
1. Cystic fibrosis (CF). Cystic fibrosis is a genetic condition that causes slowly
           progressive lung disease. It occurs in people of all social class so the disease itself
           is independent of social factors. There is considerable variation in the outcome of CF
           in different children. There are many potential causes for these differences but the
           available literature would suggest that a significant part of this variability is due to
           social factors. While there are no prospective clinical studies, the limited information
           from database reviews suggest that socially deprived children have significantly worse
           outcomes. In the US, children living in poverty are twice as likely to be underweight
           and over three times more likely to die (25). UK data is similar - disadvantaged
           children have worse growth parameters and lower lung function compared to richer
           children (26).

        2. Type 1 diabetes (T1D). Type 1 diabetes is a multi-factorial disease. It is not an
           autosomal recessive disease like CF but genetic predisposition can be one of its
           predisposing features. As with the data on CF, socio-economic deprivation has been shown
           to have a significant adverse effect on outcome in type 1 diabetes. In the US, glycemic
           control amongst young adults was significantly worse amongst disadvantaged young adults
           (27). A retrospective review of New Zealand children with type 1 diabetes also showed
           that poor socio-economic status and Polynesian ethnicity were significantly associated
           with poor glycemic control and long term complications (28).

        3. Chronic kidney disease (CKD). Chronic kidney disease may be due to congenital, acquired,
           or hereditary causes. Within all these groups, socioeconomic status, gender, and race
           may influence disease progression and outcomes. It has been shown in children with
           chronic kidney disease, primarily from the United States, that it was more common in
           low- and middle- income families to have an abnormal birth history such as prematurity,
           low birth weight or small for age which predisposes to the development of renal disease
           (29). In addition, blood pressure control and height deficits improve faster in children
           of families with higher income. In Canada, Aboriginals have a higher prevalence of
           severe chronic kidney disease and a 77% increased mortality risk (30,31) and a lower
           likelihood of nephrology clinic visits (32). Aboriginal children and young adults with
           chronic kidney disease are more likely to have glomerulonephritis as a cause of kidney
           disease compared to Caucasians and are more likely to reach end stage renal disease
           (33). In contrast, lower mortality risks are seen in East Asian and Indo Asian Canadian
           adults starting dialysis (34). There is still much to be studied on the influence of
           these various factors in renal health and disease.

      STUDY DESIGN.

        1. Study Objective. We wish to determine the influence of education, income, race and
           access to health care upon health outcomes in children with chronic diseases in British
           Columbia.

        2. Justification. While the effects of social deprivation on health outcomes are commonly
           discussed, it is surprising how little prospective research there is to quantify the
           adverse effects of social inequity. 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 firm data relevant
           for those who manage children with chronic diseases in BC, we wish to perform a cross
           sectional observational study of the relationship between social variables and outcome
           in children with cystic fibrosis, type 1 diabetes and chronic kidney disease.

        3. General design. All families in the three clinics will initially be informed of the
           study by letter. When the child is due for regular follow-up assessment, the parents
           will be approached during the clinic visit and invited to join the study. Their
           participation will only involve the completion of a questionnaire. The research
           assistant will collect the data at interview and will subsequently (with parental
           permission) retrieve laboratory results from records of previous clinic visits to assess
           measured health trends over time. The study protocol does not add any further
           investigations other than the questionnaire. Apart from the variable time needed for
           parent information and consent, the questionnaire itself will require no more than about
           30 minutes to complete.

        4. Questionnaire. We will use a socio-economic assessment questions that we are already
           using in our study of quality of life in parents caring for children needing home
           ventilation. It is a conventional form assessing education level, employment, income,
           partnership status and ethnicity. This last is very important because of the poorer
           health outcomes already known to be associated with Aboriginal background. The proxy for
           access to health care will be distance to the main specialty clinic and number of visits
           in the last year.

        5. Analysis. The relationship between socio-economic variables plus ethnicity and outcome
           will be examined using multiple linear regression analysis. In the absence of relevant
           literature, there are too many unknowns to allow any reliable form of power analysis or
           patient number calculation to be performed. One accepted 'rule of thumb' is that there
           should be at least 10 patients for each predictive variable in multiple linear
           regression analysis. We will concentrate on 6 to 8 of the main social factors and will
           try to enroll over 100 patients within each sub-specialty - enough to ensure 15 to 20
           patient outcomes for each variable.
observational model: Family-Based
time perspective: Cross-Sectional
measure: Level of glycosylated hemoglobin (HbA1C)
time frame: 1 year
description: 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.
measure: Height/weight
time frame: 1 year
description: 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.
measure: Lung Function Tests
time frame: 1 year
description: 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.
measure: Glomerular filtration rate (GFR)
time frame: 1 year
description: 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.
measure: Albumin/creatinine ratio
time frame: 1 year
description: 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.
arm group label: Children with Chronic Medical Conditions
description: 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.
intervention type: Other
intervention name: Social Determinants Questionnaire
description: The questionnaire contains a general background information section common to all medical conditions. It then contains separate sections with medical condition specific questions.
arm group label: Children with Chronic Medical Conditions
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 17 Years
healthy volunteers: No
last name: Mike Seear, MD
role: Principal Investigator
affiliation: British Columbia's Children's Hospital
last name: Mike Seear, MD
role: Principal Investigator
affiliation: BCCH
facility: 
country: Canada
citation: 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.
PMID: 11371397
citation: 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.
PMID: 24429092
citation: 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.
PMID: 21458731
citation: 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.
PMID: 18679654
citation: 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.
PMID: 23932090
citation: 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.
PMID: 17942955
citation: 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.
PMID: 8971883
citation: 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.
PMID: 18981441
citation: 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.
PMID: 22927509
citation: 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.
PMID: 20116643
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Michael Seear
investigator title: Principle Investigator
mesh term: Cystic Fibrosis
mesh term: Renal Insufficiency
mesh term: Renal Insufficiency, Chronic
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Fibrosis