Usefulness of Cardiovascular Disease (CVD) Management Sol... | NCT03392259

Studies
Usefulness of Cardiovascular Disease (CVD) Management Solution

NCT03392259

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Mar 26, 2018Actual

Enrollment

666Estimated

Phase

Not Applicable

Conditions

Cardiovascular Diseases

Interventions

Smartphone app

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 19, 2018Actual

Primary Completion Date

Feb 1, 2019Estimated

Completion Date

Sep 1, 2019Estimated

First Submitted Date

Jan 1, 2018

First Submission Date that Met QC Criteria

Jan 1, 2018

First Posted Date

Jan 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2018

Last Update Posted Date

Mar 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

666Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	No Intervention	conventional treatment
App group	Experimental	conventional treatment + use of smartphone app.	Behavioral: Smartphone app

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Smartphone app	Behavioral	Installment and use of smartphone app	App group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Systolic blood pressure	automated blood pressure, mmHg	3 & 6 months
Diastolic blood pressure	automated blood pressure, mmHg	3 & 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Si-Hyuck Kang	Contact	82317877027		eandp303@gmail.com

Overall Officials

Name	Affiliation	Role
Jung-Won Suh, MD	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital	Recruiting	Seongnam-si	Gyeonggi-do	463707	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34862449	Derived	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.