Clinical trial NCT03397849: Lifestyle Intervention Using Mobile Technology in Patients With High Cardiovascular Risk
Official title: Lifestyle Intervention Using Mobile Technology in Patients With High Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Prevention
Digital Health
Lifestyle Risk Reduction
Keywords: Primary prevention
Lifestyle intervention
Digital health
Cardiovascular disease prevention
Lead sponsor: Ministry of Health, Turkey
Sponsor class: OTHER_GOV
Collaborators: name: Turk Telekomunikasyon A.Ş., Istanbul, Turkey
First posted: 2018-01-12
Enrollment: 320
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Atherosclerotic cardiovascular disease (ASCVD) risk score of individual patients at 12 months that is adjusted to baseline ASCVD risk score.
timeFrame: 12 months
Secondary outcomes:
measure: Smoke abstinence
timeFrame: 12 months
measure: Improvement in high sensitive C reactive protein levels (hs-CRP) (mg/L) (hs-CRP value at 12 months that is adjusted to baseline value)
timeFrame: 12 months
measure: Improvement in quality of life
timeFrame: 12 months
measure: Peak oxygen consumption value at 12 months that is adjusted to baseline value
timeFrame: 12 months
measure: Major adverse cardiovascular events
timeFrame: 12 months
measure: Systolic and diastolic blood pressure values (mmHg) at 12 months that are adjusted to baseline values
timeFrame: 12 months
measure: Body mass index (BMI) (kg/m^2) level at 12 months that is adjusted to baseline level
timeFrame: 12 months
measure: HbA1c (%) level at 12 months that is adjusted to baseline level
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: Carotis intima-media thickness (mm) value at 12 months that is adjusted to baseline value
timeFrame: 12 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Dr. Siyami Ersek thoracic and cardiovascular surgery research and training hospital
Study officials:
References:
citation: Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.