protocolSection identificationModule nctId: NCT06330480, orgStudyIdInfo id: Check@Home, briefTitle: Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2027-11-01, completionDateStruct date: 2028-11-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Prof. Dr. Folkert W. Asselbergs, class: OTHER, collaborators name: Dutch Cardiovascular Alliance, collaborators name: University Medical Center Groningen, collaborators name: Dutch Heart Foundation, collaborators name: Dutch Kidney Foundation, collaborators name: Dutch Diabetes Research Foundation, collaborators name: Maastricht University, collaborators name: AstraZeneca BV, collaborators name: UMC Utrecht, collaborators name: Radboud University Medical Center, collaborators name: Siemens Healthineers Nederland BV, collaborators name: University of Twente, collaborators name: Roche Diagnostics Nederland BV, collaborators name: Luscii healthtech BV, collaborators name: Happitech BV, collaborators name: Stichting Radboud Universiteit, collaborators name: Stichting Netherlands Heart Institute, descriptionModule briefSummary: 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)., conditionsModule conditions: Atrial Fibrillation, conditions: Chronic Kidney Diseases, conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 320000, type: ESTIMATED, armsInterventionsModule interventions name: Intervention group, outcomesModule primaryOutcomes measure: Participation rate of the atrial fibrillation and albuminuria screening, primaryOutcomes measure: Yield of the atrial fibrillation and albuminuria screening, primaryOutcomes measure: Effectiveness of the atrial fibrillation screening, primaryOutcomes measure: Effectiveness of the albuminuria screening, secondaryOutcomes measure: Effectiveness of the atrial fibrillation screening based on incidence of MACE events, secondaryOutcomes measure: Effectiveness of the albuminuria screening based on incidence each individual MACE component, secondaryOutcomes measure: Safety of the atrial fibrillation screening, secondaryOutcomes measure: Cost-effectiveness of screening strategies compared with standard of care: treatment effectiveness based on literature., secondaryOutcomes measure: Cost-effectiveness of screening strategies compared to standard of care: treatment effectiveness based on actual observed event rates, otherOutcomes measure: False-positive rate, false-negative rate, sensitivity, specificity, positive predictive screening on atrial fibrillation and albuminuria screening., otherOutcomes measure: Characteristics of responders and non-responders, otherOutcomes measure: Effectiveness of the atrial fibrillation screening based on incidence each individual MACE component, otherOutcomes measure: Overall effectiveness of broader population-based screening strategies applied to screening on heart failure, coronary artery disease, and type 2 diabetes., eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False