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Completed

NCT Number: NCT03397849

Lifestyle Intervention Using Mobile Technology in Patients With High Cardiovascular Risk

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.

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Key information

Conditions

Primary Prevention Behavior Digital Health Lifestyle Risk Reduction Risk Reduction Behavior

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Siyami Ersek thoracic and cardiovascular surgery research and training hospital

Istanbul, 34668, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention using mobile technology

Behavioral

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 outcomes

  1. Atherosclerotic cardiovascular disease (ASCVD) risk score of individual patients at 12 months that is adjusted to baseline ASCVD risk score.

    Time frame: 12 months

    Patients with ASCVD risk score of >7.5 % are considered to have a high risk for 10-year atherosclerotic cardiovascular diseases.

Secondary outcomes

  1. Smoke abstinence

    Time frame: 12 months

    Cessation of smoking habits including non-nicotine and electronic cigarettes during past 4 weeks will be measured at 12 months

  2. 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

  3. Improvement in quality of life

    Time frame: 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.

  4. Peak oxygen consumption value at 12 months that is adjusted to baseline value

    Time frame: 12 months

    Peak VO2 will be evaluated by cardio-pulmonary exercise testing

  5. Major adverse cardiovascular events

    Time frame: 12 months

    Occurrence of death, myocardial infarction, Stroke, cardiovascular hospitalization

  6. Systolic and diastolic blood pressure values (mmHg) at 12 months that are adjusted to baseline values

    Time frame: 12 months

  7. Body mass index (BMI) (kg/m^2) level at 12 months that is adjusted to baseline level

    Time frame: 12 months

  8. HbA1c (%) level at 12 months that is adjusted to baseline level

    Time frame: 12 months

  9. 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

  10. Carotis intima-media thickness (mm) value at 12 months that is adjusted to baseline value

    Time frame: 12 months

    Carotis intima-media thickness will be evaluated by ultrasonography (USG)

Sponsors and collaborators

Lead sponsor

Ministry of Health, Turkey

Other Gov

Collaborators

  • Turk Telekomunikasyon A.Ş., Istanbul, Turkey

Registry information

Acronym: LIGHT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 12, 2018
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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