Usefulness of Cardiovascular Disease (CVD) Management Solution

NCT ID: NCT03392259

Last Updated: 2018-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

666 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-19

Study Completion Date

2019-09-01

Brief Summary

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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

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group

conventional treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

App group

conventional treatment + use of smartphone app.

Group Type EXPERIMENTAL

Smartphone app

Intervention Type BEHAVIORAL

Installment and use of smartphone app

Interventions

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Smartphone app

Installment and use of smartphone app

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Won Suh

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung-Won Suh, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Si-Hyuck Kang

Role: CONTACT

82317877027

Facility Contacts

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Jung-Won Suh

Role: primary

82-31-787-7016

Ji-Hyun Lee

Role: primary

82-31-787-8805

References

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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.

Reference Type DERIVED
PMID: 34862449 (View on PubMed)

Other Identifiers

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B-1712-438-307

Identifier Type: -

Identifier Source: org_study_id

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