Lifestyle Intervention Using Mobile Technology in Patients With High Cardiovascular Risk

Study Overview
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Brief Summary
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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.

Official Title
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Lifestyle Intervention Using Mobile Technology in Patients With High Cardiovascular Risk

Conditions
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Primary Prevention, Digital Health, Lifestyle Risk Reduction

Intervention / Treatment
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* Behavioral: Intervention using mobile technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of high risk for cardiovascular diseases (ASCVD risk score > 7.5%). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients that are randomized to usual care group will receive guideline-standardized medications and lifestyle recommendations. Cardiovascular risk management and compliance to medication and lifestyle recommendation will be assessed and controlled by three cardiologists in clinical visits performed at 6 and 12 months. For the necessary cases counseling to other specialities will be performed for smoke cessation and weight management. 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention using mobile technology (IMT) plus usual care<br>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). | Behavioral: Intervention using mobile technology<br>* 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)<br>|
| No Intervention: Only usual care<br>Patients that are randomized to only usual care group will receive guideline-standardized medications and lifestyle recommendations. Cardiovascular risk management and compliance to medication and lifestyle recommendation will be assessed and controlled by three cardiologists in clinical visits performed at 6 and 12 months. For the necessary cases counseling to other specialities will be performed for smoke cessation and weight management. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoke abstinence | Cessation of smoking habits including non-nicotine and electronic cigarettes during past 4 weeks will be measured at 12 months | 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 | 
| 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. | 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 | 12 months | 
| Major adverse cardiovascular events | Occurrence of death, myocardial infarction, Stroke, cardiovascular hospitalization | 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 | 
| 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 | Carotis intima-media thickness will be evaluated by ultrasonography (USG) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary prevention, Lifestyle intervention, Digital health, Cardiovascular disease prevention