Lifestyle Intervention Using Mobile Technology in Patients With High Cardiovascular Risk

Not Applicable

Completed

• Conditions: Digital Health; Lifestyle Risk Reduction; Primary Prevention
• Interventions: Behavioral: Intervention using mobile technology

• Registration Number: NCT03397849
• Lead Sponsor: Ministry of Health, Turkey

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2018-01-05
• Study First Posted: 2018-01-12
• Study Start: 2018-02-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-18
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention using mobile technology (IMT) plus usual care	Intervention using mobile technology	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 Outcome Measures

Name	Time	Method
Atherosclerotic cardiovascular disease (ASCVD) risk score of individual patients at 12 months that is adjusted to baseline ASCVD risk score.	12 months	Patients with ASCVD risk score of \>7.5 % are considered to have a high risk for 10-year atherosclerotic cardiovascular diseases.

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	12 months	Occurrence of death, myocardial infarction, Stroke, cardiovascular hospitalization
Improvement in quality of life	12 months	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.
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	Carotis intima-media thickness will be evaluated by ultrasonography (USG)
Smoke abstinence	12 months	Cessation of smoking habits including non-nicotine and electronic cigarettes during past 4 weeks will be measured at 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	Peak VO2 will be evaluated by cardio-pulmonary exercise testing
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

Trial Locations

Locations (1)

Dr. Siyami Ersek thoracic and cardiovascular surgery research and training hospital; 🇹🇷 Istanbul, Turkey