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Published on: September 20, 2019
Protocol for a randomized study assessing the feasibility of home-based albuminuria screening among the general
Dominique van Mil1,2, Lyanne M Kieneker1, Birgitte Evers-Roeten3
1Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Insights
Home-based screening for albuminuria can effectively detect chronic kidney disease (CKD) and cardiovascular disease (CVD) risk factors. The THOMAS study compares two screening methods to assess participation and cost-effectiveness for early detection.
Area of Science:
- Nephrology
- Cardiology
- Public Health
Background:
- Chronic kidney disease (CKD) is a growing health concern, often detected late due to its asymptomatic nature.
- CKD significantly increases the risk of cardiovascular disease (CVD) and kidney failure.
- Early detection through albuminuria screening can enable preventive treatment, but general practitioner-based screening is costly.
Purpose of the Study:
- To prospectively evaluate two home-based screening methods for albuminuria.
- To detect undiagnosed CKD and CVD risk factors in the general population.
- To assess the effectiveness and cost-effectiveness of home-based screening strategies.
Main Methods:
- The THOMAS study is a randomized, population-based trial including 15,000 individuals aged 45-80.
- Participants are invited for home-based albuminuria screening using either a standard device or a smartphone application.
- Positive results trigger further screening, with participants referred to GPs for treatment if needed.
Main Results:
- Primary endpoints include participation rates, yield of screening, and cost-effectiveness.
- The study will analyze compliance with screening protocols.
- Effectiveness of detecting CKD and CVD risk factors will be evaluated.
Conclusions:
- Home-based albuminuria screening offers a potentially effective and cost-effective alternative to traditional methods.
- The study will provide insights into population willingness and compliance for CKD screening.
- Findings may inform the development of novel screening strategies for early CKD detection.
Background:
Chronic kidney disease (CKD) is a rising public health problem that may progress to kidney failure, requiring kidney replacement therapy. It is also associated with an increased incidence of cardiovascular disease (CVD). Because of its asymptomatic nature, CKD is often detected in a late stage. Population screening for albuminuria could allow early detection of people with CKD who may benefit from preventive treatment. In case such screening is performed in a general practitioner (GP) setting, this will result in relatively high costs. Home-based screening might be an effective and cost-effective alternative.
Aim:
The THOMAS study (Towards HOMe-based Albuminuria Screening) is designed to prospectively investigate two methods for home-based population screening for increased albuminuria to detect yet undiagnosed CKD and risk factors for progression and CVD.
Methods:
This investigator initiated, randomized population-based study will include 15.000 individuals aged 45-80 years, who will be randomly assigned to be invited for a home-based screening test for albuminuria with a more conventional urine collection device or an innovative smartphone application. If the test result is positive upon confirmation (i.e., elevated albuminuria), participants are invited to a central screening facility for an elaborate screening for CKD and CVD risk factors. Participants are referred to their GP for appropriate treatment, if abnormalities are found. Primary endpoints are the participation rate, yield, and cost-effectiveness of the home-based screening and elaborate screening.
Conclusions:
The THOMAS study will evaluate the effectiveness and cost-effectiveness of home-based albuminuria screening in the general population for the early detection of CKD and CVD risk factors. It will provide insight into the willingness to participate in population screening for CKD and into the compliance of the general population to a corresponding screening protocol and compliance to participate. Thus, it may help to develop an attractive novel screening strategy for the early detection of CKD.
Trial Registration:
ClinicalTrials.gov, registration number NCT04295889, registered 05 March 2020. https://www.google.com/search?client=firefox-b-d&q=NCT04295889.
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