Usefulness of Cardiovascular Disease (CVD) Management Solution

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03392259
• Other study ID #: B-1712-438-307
• Status: Recruiting
• Phase: N/A
• First received: January 1, 2018
• Last updated: March 23, 2018
• Start date: February 19, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: March 2018
• Source: Seoul National University Hospital
• Contact: Si-Hyuck Kang
• Phone: 82317877027
• Email: eandp303[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 666
• Est. completion date: September 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Smartphone app
Installment and use of smartphone app

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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