NCT03392259

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
666

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 19, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

March 26, 2018

Status Verified

March 1, 2018

Enrollment Period

12 months

First QC Date

January 1, 2018

Last Update Submit

March 23, 2018

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Systolic blood pressure

    3 & 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

  • +4 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

conventional treatment

App group

EXPERIMENTAL

conventional treatment + use of smartphone app.

Behavioral: Smartphone app

Interventions

Smartphone appBEHAVIORAL

Installment and use of smartphone app

App group

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463707, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam, 463707, South Korea

RECRUITING

Related Publications (1)

  • Kang SH, Baek H, Cho J, Kim S, Hwang H, Lee W, Park JJ, Yoon YE, Yoon CH, Cho YS, Youn TJ, Cho GY, Chae IH, Choi DJ, Yoo S, Suh JW. Management of cardiovascular disease using an mHealth tool: a randomized clinical trial. NPJ Digit Med. 2021 Dec 3;4(1):165. doi: 10.1038/s41746-021-00535-z.

    PMID: 34862449DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Jung-Won Suh, MD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Si-Hyuck Kang

CONTACT

82317877027eandp303@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 1, 2018

First Posted

January 5, 2018

Study Start

February 19, 2018

Primary Completion

February 1, 2019

Study Completion

September 1, 2019

Last Updated

March 26, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)