Mobile App for Heart Failure

October 30, 2023 updated by: Dong-Ju Choi, Seoul National University Bundang Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Keimyung University Hospital
      • Seongnam, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Korea Univ. Guro hospital
      • Seoul, Korea, Republic of
        • Severance Hospital, Yonsei University
      • Seoul, Korea, Republic of
        • Catholic University college of medicine
      • Wonju, Korea, Republic of
        • Wonju Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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

Other: Mobile application
The mobile application provide only self-management interventions.
Placebo Comparator: AIDA/KT-app only
AIDA/KT-app only : no device link or no feedback
Other: Mobile application
The mobile application provide only self-management interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
4 weeks
HF symptom by questionnaire
Time Frame: 4 weeks
The degree of dyspnea will be evaluated by questionnaire. Range: 0(worst)-10(best)
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Application satisfaction score
Time Frame: 4 weeks
The satisfaction score will be evaluated by questionnaire. Range: 0(worst)-10(best)
4 weeks
Composite outcome
Time Frame: 4 weeks
including death, rehospitalization, and unscheduled HF visit
4 weeks
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

KT Corporation

Investigators

  • Study Chair: Dong-Ju Choi, Seoul National Univeristy Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2022

Primary Completion (Actual)

January 26, 2023

Study Completion (Actual)

January 26, 2023

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

December 19, 2022

First Posted (Actual)

December 29, 2022

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART-HF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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