van Mierlo Rutger, Scheenstra Bart, Verbeek Joost, Bruninx Anke, Kalendralis Petros, Bermejo Inigo, Dekker Andre, van 't Hof Arnoud, Spreeuwenberg Marieke, Hochstenbach Laura
Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.
Department of Radiation Oncology (Maastro), Research Institute for Oncology and Reproduction (GROW), Maastricht University, Maastricht, The Netherlands.
JMIR Res Protoc. 2025 Aug 8;14:e66068. doi: 10.2196/66068.
Atherosclerotic cardiovascular disease poses a heavy burden on the population's health and health care costs. Identifying apparently healthy individuals at risk of developing cardiovascular diseases using clinical prediction models raises awareness, facilitates shared decision-making, and supports tailored management of disease prevention. In the CARRIER project, a personalized cardiovascular risk management (CVRM) eCoach approach is cocreated, in which identified individuals receive education, guidance, and monitoring to prevent atherosclerotic cardiovascular disease through existing interventions. In this approach, an artificial intelligence-driven clinical prediction model calculates the 10-year risk for atherosclerotic cardiovascular disease, which supports informed decision-making.
This study aims to assess the effectiveness of our CVRM eCoach approach through a 10-year risk calculation of atherosclerotic cardiovascular disease, including risk factors contributing to this risk.
This pretest-posttest interventional study provides the CVRM eCoach approach for 6 months to 100 apparently healthy individuals eligible for CVRM. The CVRM eCoach approach is a multicomponent eHealth solution, including a clinical prediction under intervention model that not only calculates the 10-year risk of cardiovascular disease through conventional risk factors (smoking, blood pressure, and lipid profile) and individual characteristics (age, gender, socioeconomic status, physical activity, and diet) but also calculates how the risk changes after hypothetical lifestyle or medical interventions. The CVRM eCoach approach includes features that encourage behavior change. Most of these features include goal setting, decision cards to help decide on an intervention, intervention monitoring, remote communication, and education, all accessible from one dashboard. A practice nurse or physician consults the individuals after risk calculation with the clinical prediction model and uses behavior change features, such as the decision cards, to support shared decision-making. Data are primarily collected via the eCoach, after which the 10-year risk for atherosclerotic cardiovascular disease and its components are analyzed using paired-sample analyses.
Recruitment began in March 2024 and will continue until 100 participants have been recruited, which is expected in 2025.
We anticipate that our CVRM eCoach approach will be valuable in the primary prevention setting. During the crucial initial first months of habit formation, factors such as education, regular check-ups via the eCoach, and clear risk communication could support individuals in sustaining their medical or lifestyle interventions. We hypothesize that there will be a slight to moderate reduction in the 10-year risk of atherosclerotic cardiovascular disease, which over time will lead to significant health improvements on a larger scale.
CCMO NL84584.096.23; https://onderzoekmetmensen.nl/nl/trial/56578.
动脉粥样硬化性心血管疾病给人群健康和医疗保健成本带来沉重负担。使用临床预测模型识别有患心血管疾病风险的看似健康的个体,可提高认识、促进共同决策并支持疾病预防的个性化管理。在CARRIER项目中,共同创建了一种个性化心血管风险管理(CVRM)电子教练方法,其中被识别出的个体接受教育、指导和监测,以通过现有干预措施预防动脉粥样硬化性心血管疾病。在这种方法中,人工智能驱动的临床预测模型计算动脉粥样硬化性心血管疾病的10年风险,以支持明智的决策。
本研究旨在通过计算动脉粥样硬化性心血管疾病的10年风险,包括导致该风险的危险因素,来评估我们的CVRM电子教练方法的有效性。
这项前后测干预研究为100名符合CVRM条件的看似健康的个体提供为期6个月的CVRM电子教练方法。CVRM电子教练方法是一种多组件电子健康解决方案,包括一个干预下临床预测模型,该模型不仅通过传统危险因素(吸烟、血压和血脂水平)和个体特征(年龄、性别、社会经济地位、身体活动和饮食)计算心血管疾病的10年风险,还计算假设的生活方式或医疗干预后风险如何变化。CVRM电子教练方法包括鼓励行为改变的功能。这些功能大多包括目标设定、帮助决定干预措施的决策卡、干预监测、远程通信和教育,所有这些都可从一个仪表板访问。执业护士或医生在使用临床预测模型进行风险计算后与个体进行咨询,并使用决策卡等行为改变功能来支持共同决策。数据主要通过电子教练收集,之后使用配对样本分析来分析动脉粥样硬化性心血管疾病的10年风险及其组成部分。
招募于2024年3月开始,将持续到招募到100名参与者,预计在2025年完成。
我们预计我们的CVRM电子教练方法在一级预防环境中将很有价值。在习惯形成的关键初始几个月中,教育、通过电子教练进行定期检查以及清晰的风险沟通等因素可以支持个体维持他们的医疗或生活方式干预。我们假设动脉粥样硬化性心血管疾病的10年风险将有轻微到中度的降低,随着时间的推移,这将在更大范围内带来显著的健康改善。
CCMO NL84584.096.23;https://onderzoekmetmensen.nl/nl/trial/56578