NCT05668000

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

7 active sites

Status
completed

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

Study Start

First participant enrolled

October 19, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 29, 2022

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

December 19, 2022

Last Update Submit

October 30, 2023

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • HF symptom by application scores.

    the mean value of scores of dyspnea, fatigue, and ankle edema stored in app by participants will be evaluated. Range 0(no symptom) - 3(severe symptom)

    4 weeks

  • HF symptom by questionnaire

    The degree of dyspnea will be evaluated by questionnaire. Range: 0(worst)-10(best)

    4 weeks

Secondary Outcomes (3)

  • Composite outcome

    4 weeks

  • Application satisfaction score

    4 weeks

  • change in body water composition f

    4 weeks

Study Arms (2)

AIDA/KT-app with devices

EXPERIMENTAL

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

Other: Bluetooth-connected monitoring devices and a feedback systemOther: Mobile application

AIDA/KT-app only

PLACEBO COMPARATOR

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

Other: Mobile application

Interventions

Bluetooth-connected monitoring devices and a feedback systemOTHER

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

AIDA/KT-app with devices
Mobile applicationOTHER

The mobile application provide only self-management interventions.

AIDA/KT-app onlyAIDA/KT-app with devices

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Keimyung University Hospital

Daegu, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Catholic University college of medicine

Seoul, South Korea

Location

Korea Univ. Guro hospital

Seoul, South Korea

Location

Samsung medical center

Seoul, South Korea

Location

Severance Hospital, Yonsei University

Seoul, South Korea

Location

Wonju Severance Hospital

Wŏnju, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 38683665DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Dong-Ju Choi

    Seoul National Univeristy Bundang Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 19, 2022

First Posted

December 29, 2022

Study Start

October 19, 2022

Primary Completion

January 26, 2023

Study Completion

January 26, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations

KR(7)