CClinicalTrials.gg
CompletedNCT05668000Updated Nov 1, 2023

Mobile App for Heart Failure

An interventional study of Bluetooth-connected monitoring devices and a feedback system and Mobile application in Heart Failure, sponsored by Seoul National University Bundang Hospital. Completed at 7 sites in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-11-01.

Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 84 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    AIDA/KT-app with devices

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

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

  • Placebo comparator
    AIDA/KT-app only

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

    Other: Mobile application

Interventions

  • OtherBluetooth-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

  • OtherMobile application

    The mobile application provide only self-management interventions.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 4 weeks

  2. HF symptom by questionnaire

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

    Time frame: 4 weeks

Secondary outcomes

  1. Composite outcome

    including death, rehospitalization, and unscheduled HF visit

    Time frame: 4 weeks

  2. Application satisfaction score

    The satisfaction score will be evaluated by questionnaire. Range: 0(worst)-10(best)

    Time frame: 4 weeks

  3. change in body water composition f

    the change in body water composition from baseline to the last measurement in the intervention group

    Time frame: 4 weeks

07

Study locations

7 sites
  • Keimyung University Hospital
    Daegu, Korea, Republic of
  • Seoul National University Bundang Hospital
    Seongnam, Korea, Republic of
  • Catholic University college of medicine
    Seoul, Korea, Republic of
  • Korea Univ. Guro hospital
    Seoul, Korea, Republic of
  • Samsung medical center
    Seoul, Korea, Republic of
  • Severance Hospital, Yonsei University
    Seoul, Korea, Republic of
  • Wonju Severance Hospital
    Wonju, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05668000
Lead sponsor
Seoul National University Bundang Hospital
Collaborators
KT Corporation
Responsible party
Dong-Ju Choi (Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Dec 29, 2022
Start date
Oct 19, 2022
Primary completion
Jan 26, 2023
Completion
Jan 26, 2023
Last update
Nov 1, 2023

Study contacts

Dong-Ju Choi
study chair · Seoul National Univeristy Bundang Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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