Clinical trial NCT06330480: Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease
Official title: Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Atrial Fibrillation
Chronic Kidney Diseases
Diabetes Mellitus, Type 2
Keywords: Population-based screening
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Dutch Cardiovascular Alliance
name: University Medical Center Groningen
name: Dutch Heart Foundation
name: Dutch Kidney Foundation
name: Dutch Diabetes Research Foundation
name: Maastricht University
name: AstraZeneca
name: UMC Utrecht
name: Radboud University Medical Center
name: Siemens Healthineers Nederland BV
name: University of Twente
name: Roche Diagnostics Nederland BV
name: Happitech BV
name: Stichting Radboud Universiteit
name: Stichting Netherlands Heart Institute
name: Topicus.Healthcare BV
name: Amsterdam UMC, location AMC
First posted: 2024-03-26
Enrollment: 320000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Check@Home is a population-based screening with a phased assessment and implementation using an iterative design executed consecutively in four regions in the Netherlands.
Primary purpose: SCREENING

Brief summary: The aim of the Check@Home consortium is to set up a roadmap and infrastructure for a program to early detect atrial fibrillation and chronic kidney disease in the general population.

This will be a population-based screening with a phased implementation and an iterative design in four regions in the Netherlands (Breda, Utrecht, Arnhem, Eindhoven). In total, a random sample of 160,000 people (aged 50-75 years) will be invited to participate in the study and another random sample of 160,000 people with the same characteristics will be included in the control group in which no screening will be offered.

The overall screening program will consist of three phases: a home-based testing phase, diagnostic screening phase, and a treatment phase:

* Phase 1: Subjects will be invited for a home-based screening that includes home-based testing; urine collection for detection of elevated albuminuria, and a heart rhythm measurement using a smartphone app for detection of atrial fibrillation.
* Phase 2: Depending on the results on these home-based tests, subjects will be invited for further screening in a diagnostic screening facility. During this visit, physical data will be collected (height, weight, waist circumference, blood pressure, heart rhythm), blood will be drawn, and urine will be collected for the assessment of parameters that are indicative of a cardiovascular disease, chronic kidney disease, type 2 diabetes or their risk factors. Participants will receive a questionnaire that include questions on demographics, educational level, disease history, medication use, health literacy, and quality of life.
* Phase 3: Based on the results of the diagnostic screening, participants may be referred to their general practitioner for appropriate treatment (lifestyle advice/medication) according to the prevailing guidelines.

The primary study outcomes are:

Overall effectiveness of population based screening on atrial fibrillation and chronic kidney disease in subjects aged 50-75 years, based on:

* Participation rate of different screening strategies and phases;
* Yield of the screening (number of subjects with (newly) diagnosed disease and risk factors);
* Effectiveness of the atrial fibrillation screening, compared with standard care, based on the incidence of ischemic stroke);
* Effectiveness of the albuminuria screening, compared with standard care, based on the incidence of kidney failure events and Major Adverse Cardiovascular Events (MACE).

Detailed description: Background:

Currently, in the Netherlands there is no structured national approach for the early detection of cardiovascular disease, kidney disease, and type 2 diabetes in the general population, despite the social and economic impact of these disorders. Detecting these chronic conditions at an early stage could allow for adequate and early treatment to prevent the progression of these conditions and their complications, thereby reducing the societal and economic burden caused by these chronic diseases.

Objective of the study:

To investigate whether population-based screening of subjects aged 50-75 years can contribute to early detection and treatment of atrial fibrillation and chronic kidney disease (defined by elevated albuminuria), and thereby can contribute to prevention of the morbidity and mortality related to these diseases. This will be done by evaluating the participation rate, yield, and (cost-)effectiveness of the screening compared with standard care. Furthermore, the project aims to evaluate options for broader screening, including the early detection of heart failure, coronary artery disease, and type 2 diabetes.

Study design:

This will be a population-based screening with a phased implementation and an iterative design in four regions in the Netherlands (Breda, Utrecht, Arnhem, Eindhoven).

Participants will be invited for a home-based screening (phase 1) that includes home-based testing; urine collection for detection of elevated albuminuria as indicator of chronic kidney disease, and a heart rhythm measurement using a smartphone app for detection of atrial fibrillation. Both home-based tests will be performed with CE-marked medical devices used according to their intended use. A subset of the population will also receive a short questionnaire. Depending on the results of the home-based tests, subjects might be invited for further screening in a diagnostic screening facility (phase 2). During this visit, physical data (height, weight, waist circumference, blood pressure, heart rhythm) will be collected, blood will be drawn, and urine will be collected for the assessment of parameters that are indicative of a cardiovascular disease, chronic kidney disease, type 2 diabetes or their risk factors. Participants will receive a questionnaire that includes questions on demographics, educational level, disease history, medication use, health literacy, and quality of life. Based on the results of the diagnostic screening, participants may be referred to their general practitioner for appropriate treatment (lifestyle advice/medication) according to the prevailing guidelines. It is planned that in a future protocol amendment an alternative treatment trajectory will be added in which participants may receive further treatment in the diagnostic screening facility.

Study population:

In total, a random sample of 160,000 people (aged 50-75 years) living in one of the four selected regions in the Netherlands will be invited to participate in the study. Another random sample of 160,000 people (aged 50-75 years) living in one of the four selected regions in the Netherlands will be included in the control group in which no screening will be offered.

Eligibility criteria: Inclusion Criteria:

* aged between 50 and 75 years
* living in the selected regions (Breda, Utrecht, Arnhem, Eindhoven)

Exclusion Criteria:

* age \<50 years or \>75 years
* not living in the selected regions (Breda, Utrecht, Arnhem, Eindhoven)
* being institutionalized (e.g., subjects with intellectual disabilities or subjects living in nursing homes who have a limited life expectancy)
* participants of the previously conducted THOMAS Study (NL65228.042.18, METc 2018/687) will be excluded.

Primary outcomes:
measure: Participation rate of the atrial fibrillation and albuminuria screening
timeFrame: 1 year after screening period
measure: Yield of the atrial fibrillation and albuminuria screening
timeFrame: 1 year after screening period
measure: Effectiveness of the atrial fibrillation screening
timeFrame: Up to 10 years follow-up after screening period
measure: Effectiveness of the albuminuria screening
timeFrame: Up to 10 years follow-up after screening period
Secondary outcomes:
measure: Effectiveness of the atrial fibrillation screening based on incidence of MACE events
timeFrame: Up to 10 years follow-up after screening period
measure: Effectiveness of the albuminuria screening based on incidence each individual MACE component
timeFrame: Up to 10 years follow-up after screening period
measure: Safety of the atrial fibrillation screening
timeFrame: Up to 10 years follow-up after screening period
measure: Cost-effectiveness of screening strategies compared with standard of care: treatment effectiveness based on literature.
timeFrame: Up to 10 years follow-up after screening period
measure: Cost-effectiveness of screening strategies compared to standard of care: treatment effectiveness based on actual observed event rates
timeFrame: Up to 10 years follow-up after screening period
Other outcomes:
measure: False-positive rate, false-negative rate, sensitivity, specificity, positive predictive screening on atrial fibrillation and albuminuria screening.
timeFrame: Up to 10 years follow-up after screening period
measure: Characteristics of responders and non-responders
timeFrame: Up to 10 years follow-up after screening period
measure: Effectiveness of the atrial fibrillation screening based on incidence each individual MACE component
timeFrame: Up to 10 years follow-up after screening period
measure: Overall effectiveness of broader population-based screening strategies applied to screening on heart failure, coronary artery disease, and type 2 diabetes.
timeFrame: Up to 10 years follow-up after screening period
Locations:
city: Amsterdam
country: Netherlands
facility: Stichting Amsterdam UMC
Study officials:
affiliation: Amsterdam UMC
name: Prof. Dr. F. W. Asselbergs
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Groningen
name: Prof. Dr. R. T. Gansevoort
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Mil D, Kieneker LM, Evers-Roeten B, Thelen MHM, de Vries H, Hemmelder MH, Dorgelo A, van Etten RW, Heerspink HJL, Gansevoort RT. Participation rate and yield of two home-based screening methods to detect increased albuminuria in the general population in the Netherlands (THOMAS): a prospective, randomised, open-label implementation study. Lancet. 2023 Sep 23;402(10407):1052-1064. doi: 10.1016/S0140-6736(23)00876-0. Epub 2023 Aug 16.