Kidney Check: Diabetes, Blood Pressure & Kidney Health Checks & Care in Indigenous Communities.
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|ClinicalTrials.gov Identifier: NCT03595267|
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : April 23, 2021
|Condition or disease||Intervention/treatment|
|Chronic Kidney Disease Diabetes Hypertension||Other: Point-of-care screening|
Compared to the general population, Indigenous people disproportionately suffer from higher rates of diabetes, hypertension, obesity, and chronic kidney disease (CKD), when compared to their non-Indigenous counterparts. However, rates of these morbidities are greatest for Indigenous individuals living in rural and remote areas, where social inequalities such as poverty and poor access to services - in particular reduced access to primary care and nephrology specialists - are the most the salient.
If caught and treated early in its course, kidney failure is often preventable, especially for those at the highest risk of progression. However, CKD is often unrecognizable and asymptomatic until it is in its later stages, when the chances of preventing kidney failure are limited. Therefore, in order to administer targeted therapeutic interventions, early identification and stratification of those at highest risk of CKD are urgently needed. Screening programs using state of the art point-of-care testing equipment with blood and urine samples can test for CKD both quickly and accurately. While general population-based screening have not been found to be beneficial, targeted screening directed toward high-risk patients with diabetes and high blood pressure, or high-risk populations known to progress rapidly or have limited access to primary health care, are cost-effective. In particular, research has shown that the cost utility of one-off, point-of-care screening and treatment for CKD in rural and remote Indigenous communities is highly cost-effective when compared to usual care provided in these geographic areas.
The goal of this project is to develop a platform that will enable the early diagnosis of Indigenous adults and children with CKD living in Indigenous communities across Canada, and lead to treatment and follow up care targeted to each individual's risk of kidney failure. By developing mobile mass screening and prevention initiatives in adults and children for the prevention of CKD and kidney failure, appropriate treatment and follow-up will continue, and rates of CKD progression will decline, with fewer patients reaching kidney failure requiring dialysis. In addition, this project will further demonstrate the benefits of front line surveillance, risk prediction and treatment, and lead to novel insights regarding prognosis, and the factors driving kidney disease in Indigenous communities, ultimately serving as the gold-standard model for delivery of kidney care across Canada.
|Study Type :||Observational|
|Estimated Enrollment :||2500 participants|
|Official Title:||Optimal Approaches to Chronic Kidney Disease Case Finding in Indigenous Communities|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||December 2024|
Rural and Remote Indigenous Communities
Point-of-care screening for Chronic Kidney Disease, Diabetes, and Hypertension will be administered in rural and remote communities in Manitoba, British Columbia, Alberta, Saskatchewan, and Ontario.
Other: Point-of-care screening
After consent is obtained, a registered nurse will administer a demographic questionnaire, collecting the participant's personal health number, age, gender, date of birth, and name of community. Physical data including height, weight, and blood pressure will also be collected. A blood sample and a urine sample will be taken, with point-of-care testing being performed during the screening appointment to allow for results of the testing to be received and discussed with each patient at the time of the appointment. After screening, to ensure a "closed loop" system of care, patients at the highest risk of kidney failure will be referred to a nephrologist, while those at lower risk will be referred to their primary care provider with specific treatment and re-testing recommendations. If a participant has no primary care provider, one will be found.
- Biomarkers of Kidney Function [ Time Frame: 1 day (At time of screening) ]eGFR; Albuminuria; Urine ACR
- Diabetes [ Time Frame: 1 day (At time of screening) ]Defined as a Hemoglobin A1c => 6.5%
- Elevated Blood Pressure [ Time Frame: 1 day (At time of screening) ]Defined as a Systolic Blood Pressure > 140 mmHg, or Diastolic Blood Pressure > 90mmHg
- Kidney Failure Risk [ Time Frame: 1 day (At time of screening) ]Measured using the Kidney Failure Risk Equation
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): NCT03595267
|Contact: Heather Martin, BScfirstname.lastname@example.org|
|Alberta Health Services||Active, not recruiting|
|Calgary, Alberta, Canada, T2W1S7|
|Canada, British Columbia|
|First Nations Research and Knowledge Exchange||Recruiting|
|West Vancouver, British Columbia, Canada, V7T 1A2|
|Contact: Catherine Turner email@example.com|
|Chronic Disease Innovation Centre||Recruiting|
|Winnipeg, Manitoba, Canada, R2V 3M3|
|Contact: Heather Martin, BSc 204.632.3667 firstname.lastname@example.org|
|Principal Investigator:||Paul Komenda, MD MHA||University of Manitoba|