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Usefulness of Cardiovascular Disease (CVD) Management Solution

Prospective Validation of Usefulness in Cardiovascular Disease (CVD) Management With CVD Management Solution Based on Interconnection to Hospital Examination

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03392259
Enrollment
666
Registered
2018-01-05
Start date
2018-02-19
Completion date
2019-09-01
Last updated
2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Brief 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 cardiovascular disease.

Interventions

BEHAVIORALSmartphone app

Installment and use of smartphone app

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with atherosclerotic cardiovascular diseae 1. history of cardiovascular disease (acute myocardial infarction, unstable angina, stable angina) 2. history of revascularization including percutaneous coronary intervention, peripheral angioplasty or bypass surgery 3. history of stroke 4. 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change of 10-year ASCVD risk (10-year ASCVD risk at 6 months - 10-year ASCVD risk at baseline)6 monthsdelta 10-year ASCVD risk between baseline and 6months, %

Secondary

MeasureTime frameDescription
Diastolic blood pressure3 & 6 monthsautomated blood pressure, mmHg
lipid profiles (total cholesterol, LDL, HDL)6 monthslipid profiles at 6 months, mg/dL
body mass index6 monthsbody mass index at 6 months, kg/m2
smoking rate6 monthssmoking rate at 6 months, %
Systolic blood pressure3 & 6 monthsautomated blood pressure, mmHg
depression scale questionnaire6 monthsPatient Health Questionanaire-9, total score 27 (0-27)
drug compliance6 monthsMedication Adherence Rating Scale (MARS), total score 10 (0-10)
App service satisfaction survey6 monthsPatient Activation Measure-13, total score 39 (0-39)
degree of moderate physical activity6 monthsGodin Leisure-Time Exercise Questionnaire, total score (0-7)

Countries

South Korea

Contacts

Primary ContactSi-Hyuck Kang
eandp303@gmail.com82317877027

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026