Cardiovascular DiseasesNCT03392259
Usefulness of Cardiovascular Disease (CVD) Management Solution
A study testing Smartphone app in people with Cardiovascular Diseases, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
We previously developed the smartphone app (Heart4U) which is coupled with electronic medical record system in Seoul National University Bundang Hospital. In this study, we aim to evaluate clinical usefulness of smartphone app regarding the control of conventional risk factors in patients with history of… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Smartphone app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 666 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 19 Feb 2018to 1 Sep 2019
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with atherosclerotic cardiovascular diseae
- history of cardiovascular disease (acute myocardial infarction, unstable angina, stable angina)
- history of revascularization including percutaneous coronary intervention, peripheral angioplasty or bypass surgery
- history of stroke
- history of peripheral arterial disease presumed to be of atherosclerotic origin
- Patients who have smartphone and can use app by themselves
- Patients who can speak and read Korean language
Who cannot join
- Patients with evidences of delirium, confusion or impaired consciousness
- Patients who are not familiar to smartphone or app
- Patients who are not supposed to follow the study protocol adequately.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Bundang Hospital
Seongnam, Seongnam, 463707
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463707
About this study
Official title: Prospective Validation of Usefulness in Cardiovascular Disease (CVD) Management With CVD Management Solution Based on Interconnection to Hospital Examination
We previously developed the smartphone app (Heart4U) which is coupled with electronic medical record system in Seoul National University Bundang Hospital. In this study, we aim to evaluate clinical usefulness of smartphone app regarding the control of conventional risk factors in patients with history of cardiovascular disease.
- Conditions
- Cardiovascular Diseases
- Being tested
- Smartphone app
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone appBehavioural
Installment and use of smartphone app
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | conventional treatment |
| App group | Experimental | conventional treatment + use of smartphone app. Receives: Behavioral: Smartphone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of 10-year ASCVD risk (10-year ASCVD risk at 6 months - 10-year ASCVD risk at baseline)
delta 10-year ASCVD risk between baseline and 6months, %
Measured: 6 months
Secondary outcomes (9)
Systolic blood pressure
automated blood pressure, mmHg
Measured: 3 & 6 months
Diastolic blood pressure
automated blood pressure, mmHg
Measured: 3 & 6 months
lipid profiles (total cholesterol, LDL, HDL)
lipid profiles at 6 months, mg/dL
Measured: 6 months
body mass index
body mass index at 6 months, kg/m2
Measured: 6 months
smoking rate
smoking rate at 6 months, %
Measured: 6 months
degree of moderate physical activity
Godin Leisure-Time Exercise Questionnaire, total score (0-7)
Measured: 6 months
depression scale questionnaire
Patient Health Questionanaire-9, total score 27 (0-27)
Measured: 6 months
drug compliance
Medication Adherence Rating Scale (MARS), total score 10 (0-10)
Measured: 6 months
App service satisfaction survey
Patient Activation Measure-13, total score 39 (0-39)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start19 Feb 2018
- Primary completion1 Feb 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 666 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Won Suh, Seoul National University Hospital
- Investigators
- Jung-Won Suh, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392259
- Sponsor's protocol ID
- B-1712-438-307
- Status last verified
- Oct 2026
- First submitted
- 1 Jan 2018
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kang SH, Baek H, Cho J, Kim S, Hwang H, Lee W, Park JJ, Yoon YE, Yoon CH, Cho YS, Youn TJ, Cho GY, Chae IH, Choi DJ, Yoo S, Suh JW. Management of cardiovascular disease using an mHealth tool: a randomized clinical trial. NPJ Digit Med. 2021 Dec 3;4(1):165. doi: 10.1038/s41746-021-00535-z.
PubMed 34862449
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of Usefulness in Cardiovascular Disease (CVD) Management With CVD Management Solution Based on Interconnection to Hospital Examination
- ClinicalTrials.gov ID
- NCT03392259
- Acronym / sponsor ID
- B-1712-438-307
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 666 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We previously developed the smartphone app (Heart4U) which is coupled with electronic medical record system in Seoul National University Bundang Hospital. In this study, we aim to evaluate clinical usefulness of smartphone app regarding the control of conventional risk factors in patients with history of cardiovascular disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –conventional treatment |
| App group | Experimental | Behavioral: Smartphone appconventional treatment + use of smartphone app. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with atherosclerotic cardiovascular diseae
- Patients who have smartphone and can use app by themselves
- Patients who can speak and read Korean language
Key exclusion criteria (3 listed)
- Patients with evidences of delirium, confusion or impaired consciousness
- Patients who are not familiar to smartphone or app
- Patients who are not supposed to follow the study protocol adequately.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone appInstallment and use of smartphone app | Behavioural | App group |
Primary outcome
Change of 10-year ASCVD risk (10-year ASCVD risk at 6 months - 10-year ASCVD risk at baseline)
Time frame: 6 months
delta 10-year ASCVD risk between baseline and 6months, %
9 secondary outcomes
Systolic blood pressure
Time frame: 3 & 6 months
Diastolic blood pressure
Time frame: 3 & 6 months
lipid profiles (total cholesterol, LDL, HDL)
Time frame: 6 months
body mass index
Time frame: 6 months
smoking rate
Time frame: 6 months
degree of moderate physical activity
Time frame: 6 months
depression scale questionnaire
Time frame: 6 months
drug compliance
Time frame: 6 months
App service satisfaction survey
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Results publication: PubMed 34862449Kang SH, Baek H, Cho J, Kim S, Hwang H, Lee W, Park JJ, Yoon YE, Yoon CH, Cho YS, Youn TJ, Cho GY, Chae IH, Choi DJ, Yoo S, Suh JW. Management of cardiovascular disease using an mHealth tool: a randomized clinical trial. NPJ Digit Med. 2021 Dec 3;4(1):165. doi: 10.1038/s41746-021-00535-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Won Suh, MD principal investigator
Seoul National University Bundang Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone app in people with Cardiovascular Diseases, run by Seoul National University Hospital at 2 sites in South Korea.
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 7 inclusion and 3 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
Change of 10-year ASCVD risk (10-year ASCVD risk at 6 months - 10-year ASCVD risk at baseline) (time frame: 6 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 NCT03392259, 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 2 Nov 2026.