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Clinical Trials/NCT03392259
NCT03392259
Unknown
Not 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 enrollmentFebruary 19, 2018
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ConditionsCardiovascular Diseases

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Seoul National University Hospital
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)
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
February 19, 2018
End Date
September 1, 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jung-Won Suh

Professor

Seoul National University Hospital

Eligibility Criteria

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.

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)

Study Sites (1)

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