Lifestyle Intervention Using Mobile Technology in Patients With High Cardiovascular Risk

Primary Prevention Clinical Trial

— LIGHT  

Official title:

Lifestyle Intervention Using Mobile Technology in Patients With High Cardiovascular Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397849
• Other study ID #: LIGHT
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2020
• Source: Ministry of Health, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Digital Health
• Lifestyle Risk Reduction
• Primary Prevention

Intervention

Behavioral:
• 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)

Locations

Country	Name	City	State
Turkey	Dr. Siyami Ersek thoracic and cardiovascular surgery research and training hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Health, Turkey	Turk Telekomunikasyon A.S., Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Smoke abstinence	Cessation of smoking habits including non-nicotine and electronic cigarettes during past 4 weeks will be measured at 12 months	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Major adverse cardiovascular events	Occurrence of death, myocardial infarction, Stroke, cardiovascular hospitalization	12 months
Secondary	Systolic and diastolic blood pressure values (mmHg) at 12 months that are adjusted to baseline values		12 months
Secondary	Body mass index (BMI) (kg/m^2) level at 12 months that is adjusted to baseline level		12 months
Secondary	HbA1c (%) level at 12 months that is adjusted to baseline level		12 months
Secondary	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
Secondary	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