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

Обзор

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).

Подробное описание

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.

Вмешательства

• Другое Intervention group
  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

Первичные конечные точки

• Participation rate of the atrial fibrillation and albuminuria screening [Срок оценки: 1 year after screening period]
• Yield of the atrial fibrillation and albuminuria screening [Срок оценки: 1 year after screening period]
• Effectiveness of the atrial fibrillation screening [Срок оценки: Up to 10 years follow-up after screening period]
• Effectiveness of the albuminuria screening [Срок оценки: Up to 10 years follow-up after screening period]

Вторичные конечные точки (5)

• Effectiveness of the atrial fibrillation screening based on incidence of MACE events [Срок оценки: Up to 10 years follow-up after screening period]
• Effectiveness of the albuminuria screening based on incidence each individual MACE component [Срок оценки: Up to 10 years follow-up after screening period]
• Safety of the atrial fibrillation screening [Срок оценки: Up to 10 years follow-up after screening period]
• Cost-effectiveness of screening strategies compared with standard of care: treatment effectiveness based on literature. [Срок оценки: 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 [Срок оценки: Up to 10 years follow-up after screening period]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Нидерланды · 1 центр

• Stichting Amsterdam UMC — Amsterdam

Публикации

• 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/ PMID 37597522

Идентификаторы

NCT: NCT06330480 · Check@Home

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗