Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 320,000
- 试验地点
- 1
- 主要终点
- Participation rate of the atrial fibrillation and albuminuria screening
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged between 50 and 75 years
- •living in the selected regions (Breda, Utrecht, Arnhem, Eindhoven)
排除标准
- •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.
结局指标
主要结局
Participation rate of the atrial fibrillation and albuminuria screening
时间窗: 1 year after screening period
* 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).
Yield of the atrial fibrillation and albuminuria screening
时间窗: 1 year after screening period
* 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).
Effectiveness of the atrial fibrillation screening
时间窗: Up to 10 years follow-up after screening period
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).
Effectiveness of the albuminuria screening
时间窗: Up to 10 years follow-up after screening period
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').
次要结局
- 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)
研究者
Prof. Dr. Folkert W. Asselbergs
Prof. Dr. F. W. Asselbergs
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)