NCT03392259UnknownNot Applicable
Prospective Validation of Usefulness in Cardiovascular Disease (CVD) Management With CVD Management Solution Based on Interconnection to Hospital Examination
Seoul National University Hospital1 site in 1 country666 target enrollmentStarted: February 19, 2018Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 666
- Locations
- 1
- Primary Endpoint
- Change of 10-year ASCVD risk (10-year ASCVD risk at 6 months - 10-year ASCVD risk at baseline)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control group
No Intervention
conventional treatment
App group
Experimental
conventional treatment + use of smartphone app.
Intervention: Smartphone app (Behavioral)
Outcomes
Primary Outcomes
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, %
Secondary Outcomes
- Systolic blood pressure(3 & 6 months)
- App service satisfaction survey(6 months)
- degree of moderate physical activity(6 months)
- Diastolic blood pressure(3 & 6 months)
- lipid profiles (total cholesterol, LDL, HDL)(6 months)
- body mass index(6 months)
- smoking rate(6 months)
- drug compliance(6 months)
- depression scale questionnaire(6 months)
Investigators
Jung-Won Suh
Professor
Seoul National University Hospital
Study Sites (1)
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