Usefulness of Cardiovascular Disease (CVD) Management Solution

Not Applicable

• Conditions: Cardiovascular Diseases
• Interventions: Behavioral: Smartphone app

• Registration Number: NCT03392259
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-01
• Study First Submitted QC: 2018-01-01
• Study First Posted: 2018-01-05
• Study Start: 2018-02-19
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-23
• Last Update Posted: 2018-03-26
• Primary Completion: 2019-02-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 666

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
App group	Smartphone app	conventional treatment + use of smartphone app.

Primary Outcome Measures

Name	Time	Method
Change of 10-year ASCVD risk (10-year ASCVD risk at 6 months - 10-year ASCVD risk at baseline)	6 months	delta 10-year ASCVD risk between baseline and 6months, %

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of