Mobile App for Heart Failure

NCT ID: NCT05668000

Last Updated: 2023-11-01

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

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-19

Study Completion Date

2023-01-26

Brief Summary

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The investigators developed a mobile health platform to self-management in HF. The aim of this study is to evaluate whether this smartphone app-based intervention can improve symptoms of HF when compared to usual care in HF patients.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AIDA/KT-app with devices

AIDA/KT-app with devices : with device link and with feedback

Group Type EXPERIMENTAL

Bluetooth-connected monitoring devices and a feedback system

Intervention Type OTHER

AIDA/KT-app with devices and feedback:

The mobile application provide self-management interventions with devices including sphygomanometer and body water meter and a feedback system

Mobile application

Intervention Type OTHER

The mobile application provide only self-management interventions.

AIDA/KT-app only

AIDA/KT-app only : no device link or no feedback

Group Type PLACEBO_COMPARATOR

Mobile application

Intervention Type OTHER

The mobile application provide only self-management interventions.

Interventions

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Bluetooth-connected monitoring devices and a feedback system

AIDA/KT-app with devices and feedback:

The mobile application provide self-management interventions with devices including sphygomanometer and body water meter and a feedback system

Intervention Type OTHER

Mobile application

The mobile application provide only self-management interventions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients aged 20 years or older hospitalized for acute heart failure.
* Patients who have obvious symptoms or sign of HF at admission
* N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥400 pg/mL or brain natriuretic peptide (BNP) ≥100 pg/mL.
* participants should be able to use smartphone well.

Exclusion Criteria

* Patients who have baseline systolic blood pressure \<90 mmHg or resting heart rate \<50 beats per minutes
* Patients who cannot use smartphone
* Patients who had cardiac implantable electronic device will be excluded
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KT Corporation

INDUSTRY

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong-Ju Choi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong-Ju Choi

Role: STUDY_CHAIR

Seoul National Univeristy Bundang Hospital

Locations

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Keimyung University Hospital

Daegu, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Catholic University college of medicine

Seoul, , South Korea

Site Status

Korea Univ. Guro hospital

Seoul, , South Korea

Site Status

Samsung medical center

Seoul, , South Korea

Site Status

Severance Hospital, Yonsei University

Seoul, , South Korea

Site Status

Wonju Severance Hospital

Wŏnju, , South Korea

Site Status

Countries

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South Korea

References

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Yoon M, Lee S, Choi JY, Jung MH, Youn JC, Shim CY, Choi JO, Kim EJ, Kim H, Yoo BS, Son YJ, Choi DJ. Effectiveness of a Smartphone App-Based Intervention With Bluetooth-Connected Monitoring Devices and a Feedback System in Heart Failure (SMART-HF Trial): Randomized Controlled Trial. J Med Internet Res. 2024 Apr 29;26:e52075. doi: 10.2196/52075.

Reference Type DERIVED
PMID: 38683665 (View on PubMed)

Other Identifiers

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SMART-HF

Identifier Type: -

Identifier Source: org_study_id

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