Lifestyle Intervention Using Mobile Technology in Patients With High Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Atherosclerotic cardiovascular disease (ASCVD) risk score of individual patients at 12 months that is adjusted to baseline ASCVD risk score.
研究概览
简要总结
In the present study, investigators aim to compare intervention using mobile technology (IMT) plus usual care with only usual care in patients with a high risk for cardiovascular diseases (CVD). Investigators hypothesize that IMT plus usual care reduces the CVD risk and improves the secondary outcomes in this population through 12 months of follow-up period. Patients presented to the outpatient clinics in a tertiary hospital (Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Research and Training Hospital, Istanbul, Turkey) who were considered to be eligible according to inclusion and exclusion criteria will be enrolled to the study. The eligibility criteria is; Patients between 20 to 79 years old who are in high risk for CVD (10 years ASCVD risk ≥ 7.5%). Patients with prior CVD events (myocardial infarction, percutaneous coronary intervention, coronary artery by-pass grafting operation, stroke and peripheral artery disease), pregnancy, communication problems, severe neuropsychiatric problems and chronic kidney disease are excluded from the study. In addition, patients that are unable to use smartphone phone are also excluded.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of high risk for cardiovascular diseases (ASCVD risk score > 7.5%).
排除标准
- •Patients with prior cardiovascular events including myocardial infarction, percutaneous coronary intervention, coronary artery by-pass grafting operation, stroke and peripheral artery disease.
- •Pregnancy
- •Patients with communication problems or severe neuropsychiatric problems
- •Patients with chronic kidney disease
- •Patients who are considered for being unable to use smart phone
结局指标
主要结局
Atherosclerotic cardiovascular disease (ASCVD) risk score of individual patients at 12 months that is adjusted to baseline ASCVD risk score.
时间窗: 12 months
Patients with ASCVD risk score of \>7.5 % are considered to have a high risk for 10-year atherosclerotic cardiovascular diseases.
次要结局
- Improvement in quality of life(12 months)
- HbA1c (%) level at 12 months that is adjusted to baseline level(12 months)
- Plasma fasting lipid levels (total cholesterol, low density lipoprotein, high density lipoprotein and trigliserid) (mg/dL) at 12 months that are adjusted to baseline levels(12 months)
- Carotis intima-media thickness (mm) value at 12 months that is adjusted to baseline value(12 months)
- Smoke abstinence(12 months)
- Improvement in high sensitive C reactive protein levels (hs-CRP) (mg/L) (hs-CRP value at 12 months that is adjusted to baseline value)(12 months)
- Peak oxygen consumption value at 12 months that is adjusted to baseline value(12 months)
- Major adverse cardiovascular events(12 months)
- Systolic and diastolic blood pressure values (mmHg) at 12 months that are adjusted to baseline values(12 months)
- Body mass index (BMI) (kg/m^2) level at 12 months that is adjusted to baseline level(12 months)
研究者
Ahmet İlker Tekkeşin
Principal investigator
Ministry of Health, Turkey