Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease

NCT06330480 | Enrolling By Invitation DMC

• 1 other identifier: Check@Home
• Study Type: interventional
• Target: 320,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Atrial Fibrillation; Chronic Kidney Diseases; Diabetes Mellitus, Type 2

Keywords

Population-based screening

Outcome Measures

Primary Outcomes (4)

• Participation rate of the atrial fibrillation and albuminuria screening

  * Participation rate of the home-based screening phase will be defined as the number of persons who completed the home-based screening phase relative to the number of persons invited in the corresponding arm (intention-to-screen); * Participation rate of the diagnostic screening phase will be defined as the number of persons who completed the diagnostic screening phase relative to the number of persons invited for the diagnostic screening phase in the corresponding arm (in participants invited based on an 'abnormal' result in the home-based screening phase, i.e. either confirmed elevated albuminuria or an irregular heart rhythm); * Participation rate of the treatment phase will be defined as the number of persons who completed the care initiation phase (i.e., number of participants visiting their GP; or - in future phases of the screening - the diagnostic center) relative to the number of persons referred for treatment in the corresponding arm (intention-to-screen).

  1 year after screening period

• Yield of the atrial fibrillation and albuminuria screening

  * Yield of home-based screening: number of participants tested positive (i.e., either confirmed positive urine test and/or abnormal heart rhythm test) relative to the number of persons participating in the corresponding arm (per-protocol analysis) and to the number of persons invited in the corresponding arm (intention-to-screen analysis); * Yield of diagnostic screening: number of participants with (newly) diagnosed cardiovascular or chronic kidney disease, diabetes or risk factors, relative to the number of persons participating in the corresponding arm (per-protocol analysis) and to the number of persons invited in the corresponding arm (intention-to-screen analysis); * Yield of treatment phase: number of participants completing the treatment phase relative to the number of persons participating in the corresponding arm (per-protocol analysis) and to the number of persons invited to the treatment phase in the corresponding arm (intention-to-screen analysis).

  1 year after screening period

• Effectiveness of the atrial fibrillation screening

  Effectiveness of the atrial fibrillation screening (the home-based screening program and follow-up strategy) will be based on the incidence of (fatal and non-fatal) ischemic stroke. This will be evaluated by comparing the event rates in the intervention group (the sample of 160,000 subjects invited for screening) and the control group (the sample of 160,000 subjects not invited for screening).

  Up to 10 years follow-up after screening period

• Effectiveness of the albuminuria screening

  Effectiveness of the albuminuria screening (the home-based screening program and follow-up strategy), based on the incidence of the composite outcome of kidney failure events (defined as start of dialysis, receiving a kidney transplant, or death due to kidney failure without having started kidney function replacement treatment) and MACE (for albuminuria screening defined as cardiovascular mortality, stroke, and myocardial infarction, including CABG and PCI). This will be evaluated by comparing the event rates in the population screened positive for elevated albuminuria and followed-up based on this result (i.e., participants in the standard strategy and other alternative strategies) and in the population screened positive for elevated albuminuria - at a later timepoint - and not followed-up based on this result (i.e., participants in 'alternative strategy B').

  Up to 10 years follow-up after screening period

Secondary Outcomes (5)

• Effectiveness of the atrial fibrillation screening based on incidence of MACE events

  Up to 10 years follow-up after screening period

• Effectiveness of the albuminuria screening based on incidence each individual MACE component

  Up to 10 years follow-up after screening period

• Safety of the atrial fibrillation screening

  Up to 10 years follow-up after screening period

• Cost-effectiveness of screening strategies compared with standard of care: treatment effectiveness based on literature.

  Up to 10 years follow-up after screening period

• Cost-effectiveness of screening strategies compared to standard of care: treatment effectiveness based on actual observed event rates

  Up to 10 years follow-up after screening period

Other Outcomes (4)

• False-positive rate, false-negative rate, sensitivity, specificity, positive predictive screening on atrial fibrillation and albuminuria screening.

  Up to 10 years follow-up after screening period

• Characteristics of responders and non-responders

  Up to 10 years follow-up after screening period

• Effectiveness of the atrial fibrillation screening based on incidence each individual MACE component

  Up to 10 years follow-up after screening period

Study Arms (2)

Intervention group

OTHER

This group will be invited for the screening

Other: Intervention group

Control group

NO INTERVENTION

This group will not be invited for the screening

Interventions

Intervention group OTHER

Subjects will be invited for a home-based screening (phase 1) that includes home-based testing; urine collection for detection of elevated albuminuria, and a heart rhythm measurement 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), that includes collection of physical data, blood, and urine for the assessment of parameters that are indicative of cardiovascular disease, chronic kidney disease, diabetes type 2 or their risk factors. Participants will also receive a questionnaire. Based on the results of the diagnostic screening, participants may be referred to their GP for appropriate treatment according to the prevailing guidelines (phase 3)

Intervention group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Dr. Folkert W. Asselbergs: lead
• Dutch Cardiovascular Alliance: collaborator
• University Medical Center Groningen: collaborator
• Dutch Heart Foundation: collaborator
• Dutch Kidney Foundation: collaborator
• Dutch Diabetes Research Foundation: collaborator
• Maastricht University: collaborator
• AstraZeneca: collaborator
• UMC Utrecht: collaborator
• Radboud University Medical Center: collaborator
• Siemens Healthineers Nederland BV: collaborator
• University of Twente: collaborator
• Roche Diagnostics Nederland BV: collaborator
• Happitech BV: collaborator
• Stichting Radboud Universiteit: collaborator
• Stichting Netherlands Heart Institute: collaborator
• Topicus.Healthcare BV: collaborator
• Amsterdam UMC, location AMC: collaborator

Study Sites (1)

Stichting Amsterdam UMC

Amsterdam, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 37597522 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Atrial Fibrillation; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Prof. Dr. F. W. Asselbergs

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

• Prof. Dr. R. T. Gansevoort

  UMC Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. F. W. Asselbergs

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 26, 2024
• Study Start: May 14, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)