An interventional study of Intervention using mobile technology in Primary Prevention, Digital Health and Lifestyle Risk Reduction, sponsored by Ministry of Health, Turkey. Completed at 1 site in Turkey. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2020-04-21.
Sponsored by Ministry of Health, Turkey · Not applicable, Interventional, and Prevention
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.
291 studies on the registry are indexed under Risk Reduction Behavior; 39 are open to participants now.
This study's enrollment of 320 is above the median of 201 across 250 interventional studies indexed under Risk Reduction Behavior.
Browse Risk Reduction Behavior studies →Ministry of Health, Turkey is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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.
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)
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
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Ministry of Health, Turkey