Lifestyle Intervention Using Mobile Technology in Patients With High Cardiovascular Risk (LIGHT)

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.

Study Overview

• Status: Completed
• Conditions: Primary Prevention; Lifestyle Risk Reduction; Digital Health
• Intervention / Treatment: Behavioral: Intervention using mobile technology

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34668
    • Dr. Siyami Ersek thoracic and cardiovascular surgery research and training hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intervention using mobile technology (IMT) plus usual care; 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; 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)
No Intervention: Only usual care; 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?

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

Collaborators and Investigators

• Sponsor: Ministry of Health, Turkey
• Collaborators: Turk Telekomunikasyon A.Ş., Istanbul, Turkey

Publications and helpful links

General Publications

• 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:CD012675. doi: 10.1002/14651858.CD012675.pub3.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: December 7, 2017
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 18, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Primary prevention; Lifestyle intervention; Digital health; Cardiovascular disease prevention
• Other Study ID Numbers: LiGHT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No