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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
320
Each study patients that are randomized to IMT plus usual care group will receive a group of smart devices including mobile phone (Vestel Venus e2) (Vestel, Manisa, Turkey), wristband (Xiaomi band 2) (Beijing Xiaomi Technology Co., Beijing, China), weight scale (Bluecat, Yongkang Tiansheng Electronic Co., Zhejiang, China) and blood pressure monitor (Clever Chek TD-3250) (TaiDoc Technology Co., Taipei County, Taiwan)
Dr. Siyami Ersek thoracic and cardiovascular surgery research and training hospital
Istanbul, Turkey (Türkiye)
Atherosclerotic cardiovascular disease (ASCVD) risk score of individual patients at 12 months that is adjusted to baseline ASCVD risk score.
Patients with ASCVD risk score of \>7.5 % are considered to have a high risk for 10-year atherosclerotic cardiovascular diseases.
Time frame: 12 months
Smoke abstinence
Cessation of smoking habits including non-nicotine and electronic cigarettes during past 4 weeks will be measured at 12 months
Time frame: 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)
Time frame: 12 months
Improvement in quality of life
Quality of life will be evaluated by filling World Health Organization Quality of Life questionnaire. Minimum score is 122.77 and maximum score is 387.69 with higher values are considered as better quality of life.
Time frame: 12 months
Peak oxygen consumption value at 12 months that is adjusted to baseline value
Peak VO2 will be evaluated by cardio-pulmonary exercise testing
Time frame: 12 months
Major adverse cardiovascular events
Occurrence of death, myocardial infarction, Stroke, cardiovascular hospitalization
Time frame: 12 months
Systolic and diastolic blood pressure values (mmHg) at 12 months that are adjusted to baseline values
Time frame: 12 months
Body mass index (BMI) (kg/m^2) level at 12 months that is adjusted to baseline level
Time frame: 12 months
HbA1c (%) level at 12 months that is adjusted to baseline level
Time frame: 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
Time frame: 12 months
Carotis intima-media thickness (mm) value at 12 months that is adjusted to baseline value
Carotis intima-media thickness will be evaluated by ultrasonography (USG)
Time frame: 12 months
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