Supporto Alla Prevenzione Cardiovascolare Secondaria Post-IAM Attraverso un Programma di Empowerment Web-based (PREVEN-IAM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Efficacy on measurable risk factors - diastolic blood pressure
研究概览
简要总结
The aim of this study is to assess the efficacy of an innovative program of secondary cardiovascular prevention focused on patient empowerment. This program will be characterized by a blended interaction between healthcare workers and the patients: first, a face-to-face first encounter in-hospital for risk factors profiling, followed by remote interactions through a digital approach. The digital intervention is targeted at promoting the adoption and retention of virtuous behavior (e.g. smoking cessation, healthy eating habits, physical exercise, regular assumption of pharmacological therapies), improving cardiovascular risk factors control. Moreover, an exploratory endpoint will be investigated: the reduction of the residual coronary risk.
详细描述
The experimental intervention will consist of educational, motivational and coaching actions of patients post-AMI through a web based interaction with the prevention team. This intervention will be: 1) personalized (based on a risk factor profile obtained in-hospital) 2) agreed (planned with the patient with shared decision making), 3) multidisciplinary (physician, nutritionist, psychologist, clinical research nurse), 4) blended, composed of a minimal initial interaction face-to-face and periodical reminders (educational, motivational and supportive) for secondary prevention, through email, a reserved website and a chat box. The intervention contents, targeted at patient empowerment, will take the behavioral change models into consideration as a theoretical basis.
The participants of both groups will undergo conventional cardiology follow-up visits indicated (at 1- 3-12-36-48 months). Blood tests or any other exam other than those indicated by routine clinical practice are not required in this study. Patients with diabetes who already wear the Abbot Freestyle Libre® glucose monitoring device will be asked access to device data within two periods of two weeks, before programmed cardiology visits at 1, 3 and 12 months. At 12 months and 48 months-follow-up visits, all participants will be assessed by the Atherosclerosis Prevention Unit, and the lifestyle questionnaires administered at baseline will be repeated. The intervention group will also take a satisfaction survey at 12 months.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEMI or NSTEMI
- •availability of digital communication devices (smart-phone, tablet or personal computer) and internet access
排除标准
- •active malignancies (except for skin tumors other than melanoma)
- •life expectancy <5 years
- •absolute clinical indication to undergo hospital rehabilitation cycles
- •cognitive status undermining digital communication devices use, even after proper training
- •low understanding of Italian language, either oral or written, by clinician's judgement
- •patient not foreseeing to undergo cardiology follow-up at the site
结局指标
主要结局
Efficacy on measurable risk factors - diastolic blood pressure
时间窗: 12 months
Measured through the changes in the diastolic blood pressure, measured in millimetres (mm) of mercury (Hg) (mmHg).
Efficacy on measurable risk factors - LDL-cholesterol levels
时间窗: 12 months
Measured through the changes in the LDL-cholesterol levels, measured in milligrams per deciliter (mg/dL).
Efficacy on measurable risk factors - expired carbon monoxide in smokers
时间窗: 12 months
Measured through the changes in the expired carbon monoxide (CO) in smokers, measured in parts of expired carbon monoxide per million (ppm) per hour (ppm/h), assessed through the Smokerlyzer®.
Efficacy on measurable risk factors - BMI
时间窗: 12 months
Measured through the changes in the BMI, measured in weight in kilograms divided by the square of height in meters (kg/m2).
Efficacy on measurable risk factors - systolic blood pressure
时间窗: 12 months
Measured through the changes in the systolic blood pressure, measured in millimetres (mm) of mercury (Hg) (mmHg).
Efficacy on measurable risk factors - glycemia levels
时间窗: 12 months
Measured through the changes in the glycemia levels, measured in milligrams per deciliter (mg/dL).
Efficacy on measurable risk factors - glycosylated hemoglobin in diabetic patients
时间窗: 12 months
Measured through the changes in the glycosylated hemoglobin in diabetic patients, measured in percentage (%) of glycosylated hemoglobin over total hemoglobin, or in millimole of glycated hemoglobin per mole of total hemoglobin (mmol/mol).
次要结局
- Efficacy on lifestyle changes - smoking reduction or cessation(12 months)
- Efficacy on lifestyle changes - Health Locus of Control(12 months)
- Efficacy on lifestyle changes - physical activity(12 months)
- Efficacy on lifestyle changes - adherence to a "heart-friendly" diet(12 months)
- Efficacy on lifestyle changes - self-efficacy(12 months)
- Efficacy on cardioprotective treatment adherence(12 months)
- Long-term maintenance of controlled levels of risk factors - expired carbon monoxide in smokers(48 months)
- Efficacy on secondary prevention(48 months)
- Long-term maintenance of controlled levels of risk factors - systolic blood pressure(48 months)
- Long-term maintenance of controlled levels of risk factors - diastolic blood pressure(48 months)
- Efficacy on glucose control in diabetic patients(12 months)
- Long-term maintenance of controlled levels of risk factors - BMI(48 months)
- Long-term maintenance of controlled levels of risk factors - LDL cholesterol(48 months)
- Long-term maintenance of controlled levels of risk factors - glycemia levels(48 months)
- Long-term maintenance of controlled levels of risk factors - glycosylated hemoglobin in diabetic patients(48 months)
研究者
José Pablo Werba
Principal Investigator
Centro Cardiologico Monzino