Usefulness of Cardiovascular Disease (CVD) Management Solution

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Smartphone app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>conventional treatment | |
| Experimental: App group<br>conventional treatment + use of smartphone app. | Behavioral: Smartphone app<br>* Installment and use of smartphone app<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, % | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | automated blood pressure, mmHg | 3 & 6 months | 
| Diastolic blood pressure | automated blood pressure, mmHg | 3 & 6 months | 
| lipid profiles (total cholesterol, LDL, HDL) | lipid profiles at 6 months, mg/dL | 6 months | 
| body mass index | body mass index at 6 months, kg/m2 | 6 months | 
| smoking rate | smoking rate at 6 months, % | 6 months | 
| degree of moderate physical activity | Godin Leisure-Time Exercise Questionnaire, total score (0-7) | 6 months | 
| depression scale questionnaire | Patient Health Questionanaire-9, total score 27 (0-27) | 6 months | 
| drug compliance | Medication Adherence Rating Scale (MARS), total score 10 (0-10) | 6 months | 
| App service satisfaction survey | Patient Activation Measure-13, total score 39 (0-39) | 6 months |