Mobile App for Heart Failure

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: Heart Failure
• Intervention / Treatment: Other: Bluetooth-connected monitoring devices and a feedback system; Other: Mobile application

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Application satisfaction score	The satisfaction score will be evaluated by questionnaire. Range: 0(worst)-10(best)	4 weeks
Composite outcome	including death, rehospitalization, and unscheduled HF visit	4 weeks
change in body water composition f	the change in body water composition from baseline to the last measurement in the intervention group	4 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Collaborators: KT Corporation
• Investigators: Study Chair: Dong-Ju Choi, Seoul National Univeristy Bundang Hospital

Study record dates

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: Heart Diseases; Cardiovascular Diseases; Heart Failure
• 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