Innovative Approaches for Personalised Cardiovascular Prevention: Multicenter Randomised Controlled Study and Multidisciplinary Evaluation for a National Health Service (NHS) Implementation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,020
- 试验地点
- 2
- 主要终点
- Change in the Lifestyle Category
研究概览
简要总结
The goal of this clinical trial is to study innovative approaches for personalized primary preventive interventions for cardiovascular diseases (CVD) in the population. The main questions it aims to answer are:
- efficacy and safety of the intervention
- how to implement the interventions in the NHS
Participants will be randomized in one of the four parallel arms:
- standard of care;
- genetic testing for cardiovascular genetic risk (through the cardiovascular Polygenic Risk Score or PRS);
- digital intervention with a wearable device and its app;
- digital intervention and genetic testing (PRS)
The primary outcome we are going to evaluate is the efficacy of returning PRS information of CVD measured at baseline, alone or in combination with the use of a wearable device, on two endpoints: i) change in lifestyle pattern; ii) CVD risk profile modification. The postulated hypothesis is that the achievement of these endpoints is more likely in presence of at least one of the aforementioned interventions than among subjects who receive only traditional risk assessment at baseline, nor respect to subjects receiving traditional risk assessment plus adopting wearable devices.
详细描述
The trial will consist of four phases: an enrollment phase (T0), a disclosure visit three weeks later (T1), a follow-up visit five months after the disclosure visit (T2), and a final follow-up twelve months from enrollment (T3).
Once enrolled (T0), all participants will sign the informed consent form and undergo a comprehensive assessment, which includes:
- Completing a questionnaire on socioeconomic status, area of residence, and lifestyle, using the Life's Essential 8 tool [1]. The questionnaire will cover smoking status, alcohol consumption, dietary pattern, sleep pattern, and physical activity. Participants will be classified into favorable, intermediate, or unfavorable individual lifestyle patterns according to the Life's Essential 8 score.
- Blood analysis will be performed to evaluate the lipid profile, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides.
At T1, a disclosure visit will be conducted to explain the assigned lifestyle category, share the results of the blood tests, and provide information on the expected interventions based on the assigned group.
The questionnaire will be administered at T0, T2, and T3. Blood analysis and cardiovascular profile evaluation will be conducted at both T0 and T3
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •high cardiovascular risk based on the SCORE 2 (between 2.5% and 10%)
- •age between 40 and 69 years
排除标准
- •diabetes.
- •familiar hypercholesterolemia.
- •established CVD.
结局指标
主要结局
Change in the Lifestyle Category
时间窗: 12 months
The lifestyle category will be measured using the Life's Essential 8 tool. A change will be considered achieved if there is a shift towards a more favorable lifestyle category.
Modification of the Lipid Profile
时间窗: 12 months
We will evaluate whether there is a change in the lipid profile compared to the baseline value. The modification of the lipid profile can also be considered as an indicator of the modification of the cardiovascular risk profile measured with the SCORE 2 charts.
次要结局
未报告次要终点
研究者
Boccia Stefania
Full Professor of Hygiene and Preventive Medicine
Fondazione Policlinico Universitario Agostino Gemelli IRCCS