Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:29 AM
Ignite Modification Date:
2025-12-25 @ 12:29 AM
NCT ID:
NCT03595267
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.
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.
Study:
NCT03595267
Study Brief:
Protocol Section:
NCT03595267