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Primary PreventionLIGHTNCT03397849

Lifestyle Intervention Using Mobile Technology in Patients With High Cardiovascular Risk

A study testing Intervention using mobile technology in people with Primary Prevention and Digital Health, run by Ministry of Health, Turkey at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 20 to 79 years
What is being tested?
Intervention using mobile technology
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2018to 1 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Presence of high risk for cardiovascular diseases (ASCVD risk score > 7.5%).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

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

    Istanbul, 34668

Other trials in Turkey (Türkiye)

About this study

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.

Being tested
Intervention using mobile technology
Keywords
Primary prevention, Lifestyle intervention, Digital health, Cardiovascular disease prevention
Medical subject headings
Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention using mobile technologyBehavioural

    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)

Study groups in NCT03397849
Study groupRoleWhat they receive
intervention using mobile technology (IMT) plus usual careActive comparatorEach 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).
Receives: Behavioral: Intervention using mobile technology
Only usual careNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

Secondary outcomes (10)

  1. Smoke abstinence

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

    Measured: 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)

    Measured: 12 months

  3. 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.

    Measured: 12 months

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

    Peak VO2 will be evaluated by cardio-pulmonary exercise testing

    Measured: 12 months

  5. Major adverse cardiovascular events

    Occurrence of death, myocardial infarction, Stroke, cardiovascular hospitalization

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 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

    Measured: 12 months

  10. 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)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2018
  2. Study start1 Feb 2018
  3. Primary completion1 Mar 2020
  4. Study completion1 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
None (open label)
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03397849
Sponsor's protocol ID
LIGHT
Acronym
LIGHT
Status last verified
Apr 2020
First submitted
7 Dec 2017
Last updated
21 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.

    PubMed 33769555

Questions about this trial

What is this clinical trial studying?

A study testing Intervention using mobile technology in people with Primary Prevention and Digital Health, run by Ministry of Health, Turkey at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Atherosclerotic cardiovascular disease (ASCVD) risk score of individual patients at 12 months that is adjusted to baseline ASCVD risk score. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03397849, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.

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