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OpenTrials
Completed

NCT Number: NCT05668000

Mobile App for Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keimyung University Hospital, Daegu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bluetooth-connected monitoring devices and a feedback system

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

Other

The mobile application provide only self-management interventions.

Primary outcomes

  1. HF symptom by application scores.

    Time frame: 4 weeks

    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)

  2. HF symptom by questionnaire

    Time frame: 4 weeks

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

Secondary outcomes

  1. Composite outcome

    Time frame: 4 weeks

    including death, rehospitalization, and unscheduled HF visit

  2. Application satisfaction score

    Time frame: 4 weeks

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

  3. change in body water composition f

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • KT Corporation

Registry information

Official study title

Self-Monitoring Using Mobile App for Reduction of Rehospitalization and Mortality in Heart Failure (SMART-HF)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 29, 2022
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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