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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
Sponsor:
Collaborators:
Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease
Alberta Health Services
First Nations Health Authority
First Nations Health and Social Secretariat of Manitoba
Manitoba Renal Program
Information provided by (Responsible Party):
Dr. Paul Komenda, University of Manitoba

Brief Summary:
Faced with limited access to preventative health care services, Indigenous people living in rural and remote communities are at a higher risk of Chronic Kidney Disease (CKD) and kidney failure, when compared to the general population. The goal of this project is to perform point-of-care testing for CKD and its risk factors, including diabetes and high blood pressure, for individuals residing in rural and remote Indigenous communities across the Canadian provinces of Manitoba, British Columbia, Alberta, Saskatchewan, and Ontario. In addition to providing individuals with information about their risk of developing CKD, as well as providing tailored treatment plans, this study will help provide evidence to develop a permanent CKD surveillance system in all Indigenous communities across Canada, consequently decreasing the burden of CKD and kidney failure in these communities.

Condition or disease Intervention/treatment
Chronic Kidney Disease Diabetes Hypertension Other: Point-of-care screening

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Biomarkers of Kidney Function [ Time Frame: 1 day (At time of screening) ]
    eGFR; Albuminuria; Urine ACR

  2. Diabetes [ Time Frame: 1 day (At time of screening) ]
    Defined as a Hemoglobin A1c => 6.5%

  3. Elevated Blood Pressure [ Time Frame: 1 day (At time of screening) ]
    Defined as a Systolic Blood Pressure > 140 mmHg, or Diastolic Blood Pressure > 90mmHg

  4. Kidney Failure Risk [ Time Frame: 1 day (At time of screening) ]
    Measured using the Kidney Failure Risk Equation



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Indigenous communities in rural (accessible by road), and remote (accessible by flying-in, or winter ice roads) areas of Manitoba, British Columbia, Alberta, Saskatchewan and Ontario will be targeted for the screening program.
Criteria

Inclusion Criteria:

  • All individuals aged 10 years old - 80 years old will be recruited for screening, regardless of known CKD risk factors, such as diabetes, elevated blood pressure, or family history of kidney disease.

Exclusion Criteria:

  • None.

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): NCT03595267


Contacts
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Contact: Heather Martin, BSc 204.632.3667 hmartin4@sogh.mb.ca

Locations
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Canada, Alberta
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       catherine.turner@fnha.ca   
Canada, Manitoba
Chronic Disease Innovation Centre Recruiting
Winnipeg, Manitoba, Canada, R2V 3M3
Contact: Heather Martin, BSc    204.632.3667    hmartin4@sogh.mb.ca   
Sponsors and Collaborators
University of Manitoba
Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease
Alberta Health Services
First Nations Health Authority
First Nations Health and Social Secretariat of Manitoba
Manitoba Renal Program
Investigators
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Principal Investigator: Paul Komenda, MD MHA University of Manitoba
Additional Information:
Publications:

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Responsible Party: Dr. Paul Komenda, Associate Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT03595267    
Other Study ID Numbers: HS20110 (H2016:348)
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Paul Komenda, University of Manitoba:
Indigenous Canadians
Screening Study
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency