Cystic FibrosisNCT02203084
Social Determinants in Chronic Disease in British Columbia
An observational study of Cystic Fibrosis and Diabetes Mellitus Type I, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Cystic Fibrosis, Diabetes Mellitus Type I, Chronic Renal Insufficiency
- What is being tested?
- Social Determinants Questionnaire
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2014to 1 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Any individual who attends British Columbia Children's Hospital Ambulatory clinics in the following areas: cystic fibrosis, chronic kidney disease, or type 1 diabetes
Who cannot join
- Refusal to join the study
- Acute Medical Instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Social Determinants and Access to Health Care on the Outcome of Children With Chronic Health Problems in British Columbia
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).
Read the detailed description
- 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).
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Being tested
- Social Determinants Questionnaire
- Keywords
- Cystic Fibrosis, Diabetes Mellitus Type I, Chronic Renal Insufficiency, The influence of socioeconomic variables upon outcome in children with three chronic medical diseases.
- Medical subject headings
- Cystic Fibrosis, Diabetes Mellitus, Type 1, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Determinants QuestionnaireOther
The questionnaire contains a general background information section common to all medical conditions. It then contains separate sections with medical condition specific questions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Social Determinants Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Lung Function Tests
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study start1 Sep 2014
- Primary completion1 Jun 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Seear, University of British Columbia
- Investigators
- Mike Seear, MD, Principal investigator, British Columbia's Children's HospitalMike Seear, MD, Principal investigator, BCCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203084
- Sponsor's protocol ID
- H14-01278
- Status last verified
- Sep 2017
- First submitted
- 25 Jul 2014
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11371397Taylor-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.
PubMed 24429092Secrest 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.
PubMed 21458731Carter 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.
PubMed 18679654Hidalgo 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.
PubMed 23932090Gao 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.
PubMed 17942955Bulloch 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.
PubMed 8971883Gao 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.
PubMed 18981441Samuel 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.
PubMed 22927509Yeates K. Health disparities in renal disease in Canada. Semin Nephrol. 2010 Jan;30(1):12-8. doi: 10.1016/j.semnephrol.2009.10.014.
PubMed 20116643
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Social Determinants and Access to Health Care on the Outcome of Children With Chronic Health Problems in British Columbia
- ClinicalTrials.gov ID
- NCT02203084
- Acronym / sponsor ID
- H14-01278
- Keywords
- Cystic Fibrosis, Diabetes Mellitus Type I, Chronic Renal Insufficiency, The influence of socioeconomic variables upon outcome in children with three chronic medical diseases.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Sep 2014
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
- 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).
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Chronic Medical Conditions | – | Other: Social Determinants QuestionnaireThe 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. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Any individual who attends British Columbia Children's Hospital Ambulatory clinics in the following areas: cystic fibrosis, chronic kidney disease, or type 1 diabetes
Key exclusion criteria (2 listed)
- Refusal to join the study
- Acute Medical Instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Determinants QuestionnaireThe questionnaire contains a general background information section common to all medical conditions. It then contains separate sections with medical condition specific questions. | Other | Children with Chronic Medical Conditions |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Background: PubMed 11371397Schechter 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.
- Background: PubMed 24429092Taylor-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.
- Background: PubMed 21458731Secrest 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.
- Background: PubMed 18679654Carter 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.
- Background: PubMed 23932090Hidalgo 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.
- Background: PubMed 17942955Gao 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.
- Background: PubMed 8971883Bulloch 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.
- Background: PubMed 18981441Gao 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.
- Background: PubMed 22927509Samuel 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.
- Background: PubMed 20116643Yeates K. Health disparities in renal disease in Canada. Semin Nephrol. 2010 Jan;30(1):12-8. doi: 10.1016/j.semnephrol.2009.10.014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Seear, MD principal investigator
British Columbia's Children's Hospital
Mike Seear, MD principal investigator
BCCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Diabetes Mellitus Type I, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of glycosylated hemoglobin (HbA1C) (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02203084, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017.