Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention and Behavioral Change
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Change in the lifestyle profile
研究概览
简要总结
The goal of this clinical trial is to evaluate whether the disclosure of Polygenic Risk Scores (PRS) combined with personalized coaching on risk factors can lead to significant improvements in lifestyle behaviors among staff members at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The study includes staff members from Fondazione Policlinico Universitario Agostino Gemelli IRCCS, enrolled at the outpatient clinics of the Cardiology Department.
Main Research Questions:
- Does receiving PRS disclosure and personalized coaching lead to significant improvements in lifestyle behaviors compared to baseline measurements?
- How do different levels of genetic predisposition to cardiovascular diseases (CVD) impact behavioral changes following intervention? This is a single arm, pre-post clinical trial.
Participant will:
- Undergo genetic testing to assess their Polygenic Risk Score for CVDs
- receive personalized, in-person consultation with a medical cardiologis, together with and individualized recommendations for CVD prevention based on PRS results and traditional risk factors.
详细描述
This study aims to evaluate the efficacy of disclosing cardiovascular genetic risk-specifically through the Polygenic Risk Score (PRS)-in promoting the adoption of healthier lifestyle behaviors.
The enrollment period will last 18 months, with each participant taking part in the study for six months. There are three key time points in the study, T0 or baseline (enrollment phase), T1 or disclosure visit, T2 or final visit at six months. At enrollment, participants will be classified into risk categories based on cardiovascular risk using the SCORE-2 or SCORE 2-OP tool. Individuals with a SCORE-2 <10% or SCORE 2-OP <15% will be invited to join the PHC pilot study.
Study Procedures Baseline Evaluations (T0)
After providing informed consent specific to the PHC study, participants will undergo the following assessments:
- Personal and Family History, Socioeconomic and Professional Status, and Demographic Information: a structured questionnaire will be administered at T0 to collect data on medical history, family history, socioeconomic and professional status, and demographic information.
- LE'8 Lifestyle Questionnaire: the Life's Essential 8 (LE'8) lifestyle questionnaire will be administered at T0 and T2. It generates a lifestyle score that categorizes participants into three groups: favorable, intermediate, or unfavorable. Validated in European populations and widely used in clinical studies, the scale ranges from 0 to 100.
- Medical Examination: includes biometric measurements such as BMI, body circumference, heart rate, and blood pressure.
- Blood Test Results: participants will provide recent blood test results (within the last six months) for lipid profiles, C-reactive protein (CRP), and glucose or hemoglobin A1c, which will be used to calculate the SCORE-2/SCORE 2-OP score.
- Blood Sampling: blood samples will be collected to perform genetic testing and assess cardiovascular disease risk through Polygenic Risk Scores (PRS).
- Anxiety Assessment (GAD-7): Participants will complete the Generalized Anxiety Disorder (GAD-7) questionnaire at T0 and T2 to assess anxiety levels.
- Work Ability: Participants will complete the Work Ability Index (WAI) questionnaire at T0 and T2 to assess their work ability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Traditional cardiovascular risk: The risk will be assessed using SCORE 2 (low risk < 2.5%, moderate risk between 2.5% and 5%, high risk between 5% and 10%) or SCORE 2-OP (moderate risk < 7.5%, high risk between 7.5% and 15%).
- •Blood tests: Participants must have had blood tests performed within the past 6 months.
- •Age: Participants must be at least 40 years old.
排除标准
- •Very high cardiovascular risk, as measured by SCORE 2 (very high risk > 10%) or SCORE 2-OP (very high risk > 15%).
- •Diabetes.
- •Familial hypercholesterolemia.
- •Previous cardiovascular events or established CVD
研究组 & 干预措施
PRS
Lifestyle coaching and genetic intervention: calculation of the Polygenic Risk Score (PRS)
干预措施: The result of the Polygenic Risk Score will be communicated to the patient with the aim of encouraging a change in behavior (Behavioral)
结局指标
主要结局
Change in the lifestyle profile
时间窗: From enrollment to the final follow-up at 6 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 at final follow-up at 6 months compared to baseline. The overall score ranges from 0 to 100, and the categories are three: * 0-49:Poor cardiovascular health * 50-79: Intermediate cardiovascular health * 80-100: Optimal cardiovascular health
次要结局
- Change in the LDL-Cholesterol(From enrollmentto the final follow-up at 6 months)
- Accetability of PRS testing(Measured at 6 months at the final follow-up)
- Change in cardiovascular disease risk(From enrollment to the final follow-up at 6 months.)
- Smoking habit modification(From enrollment to the final follow-up at 6 months.)
- Change in Alcohol Consumption(From enrollment to the final follow-up at 6 months.)
- Anxiety(Measured at enrollment and again one month after receiving PRS results.)
- Reaction to genetic test(Measured 1 month after the baseline visit)
- Change in dietary habits score (Life's Essential 8 questionnaire)(From enrollment to the final follow-up at 6 months)
- Change in physical activity score (Life's Essential 8 questionnaire)(From enrollment to the final follow-up at 6 months)
- Feasibility of the PRS testing(Measured at 6 months at the final follow-up)
- Change in self-assessed work ability (Work Ability Index, WAI)(From enrollment to the final follow-up at 6 months.)
研究者
Stefania Boccia
Full Professor of Hygiene and Preventive Medicine
Catholic University of the Sacred Heart