Clinical trial NCT04295889: Towards HOMe-based Albuminuria Screening: an Implementation Study Testing Two Approaches
Official title: Towards HOMe-based Albuminuria Screening: an Implementation Study Testing Two Approaches
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Albuminuria
Keywords: albuminuria
chronic kidney disease
cardiovascular disease
population screening
home based
e-Health
app
hypertension
diabetes mellitus
hypercholesterolemia
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Dutch Kidney Foundation
name: E-Zorg B.V. / KPN Health
name: Healthy.io Ltd.
name: Hessels+Grob
name: Copernicus Interchange Technology B.V.
name: Amphia Hospital
First posted: 2020-03-05
Enrollment: 15032
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Chronic Kidney Disease (CKD) is a worldwide major public health problem that is associated with an increased incidence of kidney failure and cardiovascular events, that lead a high burden for affected patients and high costs for society. Symptoms of CKD occur late, when kidney function drops to below 30%. At that time preventive measures will have only limited efficacy. Protein excretion in urine has increasingly been recognized as early marker of CKD, and is often associated with high blood pressure, diabetes, and/or high cholesterol levels. These are all important risk factors for progression of kidney and cardiovascular disease. Population screening for urinary protein loss could detect a considerable number of subjects with yet unknown risk factors for progressive kidney and cardiovascular disease who can benefit of early intervention. However, there is no validated method for population screening yet. The aim is to to develop a home based population screening for elevated urinary protein loss. Two screening methods will be investigated, and yield and cost-effectiveness of these screening methods will be evaluated

Detailed description: Chronic kidney disease (CKD) is a worldwide major public health problem that is associated with an increased incidence of kidney failure and cardiovascular disease (CVD). To tackle this burden, screening for CKD among the general population could be beneficial to allow early detection and treatment. In the last decades, elevated albuminuria has increasingly been recognized as an early marker of generalized vascular endothelial damage, that predicts CKD and CVD progression.

It has been estimated that approximately 6% of the general population has elevated albuminuria, and that the majority of these subjects are not known yet with this abnormality. Among these subjects, many have hypertension, hyperlipidemia, diabetes and/or impaired kidney function, that often is also not known yet. Early detection of elevated albuminuria may be important because it gives the opportunity to invite subjects that test positive for further screening for CKD and CVD risk factors. Thus these risk factors for CKD and CVD progression could be treated in an early stage.

Population screening for albuminuria could be justified according to the WHO criteria of Wilson and Jungner , because CKD has important consequences for subjects, the course of the disease is initially symptomless, and there are treatment methods available. However, implementation research to validate screening the general population for albuminuria and related health consequences is lacking, as are cost-effectiveness studies.

In the current study the aim is to develop a home-based screening technique for detecting elevated albuminuria. Two screening methods will be investigated, and yield and cost-effectiveness of these screening methods will be evaluated

Eligibility criteria: Inclusion Criteria:

* Age 45 to 80 years.
* Living in the municipality of Breda, The Netherlands.
* Not institutionalised.

Exclusion Criteria:

* Younger than 45 years or older than 80 years.
* Not living in the municipality of Breda, The Netherlands.
* Institutionalised.

A random sample of 15.032 subjects will be drawn from the population aged 45-80 years from the municipality of Breda by the Dutch Central Bureau for Statistics (CBS).

Primary outcomes:
measure: Participation rate of the screening (i.e. home-based screening, elaborate screening and overall screening program)
timeFrame: Screening period of 6 months.
measure: The yield of albuminuria screening.
timeFrame: Screening period of 6 months.
measure: Cost-effectiveness of the screening.
timeFrame: 6 months follow-up after screening period.
Secondary outcomes:
measure: GP follow-up rate.
timeFrame: Screening period of 6 months.
measure: Characteristics of responders.
timeFrame: Screening period of 6 months.
measure: Characteristics of non-responders.
timeFrame: Screening period of 6 months.
measure: Usability scores of the two screening methods.
timeFrame: 6 months follow-up after screening period.
Other outcomes:
measure: Appropriate treatment after elaborate screening.
timeFrame: 6 months follow-up after screening period.
measure: Information regarding sensitivity and specificity of the home-based screening tests
timeFrame: Screening period of 6 months.
measure: Optimal cut-off value of albuminuria.
timeFrame: 6 months follow-up after screening period.
measure: Optimal age range for albuminuria screening.
timeFrame: 6 months follow-up after screening period.
measure: Role of health literacy in albuminuria screening.
timeFrame: 6 months follow-up after screening period.
Locations:
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Ron T Gansevoort, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: