Mobile App for Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Mobile application; Other: Bluetooth-connected monitoring devices and a feedback system

• Registration Number: NCT05668000
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-19
• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2022-12-19
• Study First Posted: 2022-12-29
• Primary Completion: 2023-01-26
• Study Completion: 2023-01-26
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AIDA/KT-app only	Mobile application	AIDA/KT-app only : no device link or no feedback
AIDA/KT-app with devices	Bluetooth-connected monitoring devices and a feedback system	AIDA/KT-app with devices : with device link and with feedback
AIDA/KT-app with devices	Mobile application	AIDA/KT-app with devices : with device link and with feedback

Primary Outcome Measures

Name	Time	Method
HF symptom by application scores.	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)
HF symptom by questionnaire	4 weeks	The degree of dyspnea will be evaluated by questionnaire. Range: 0(worst)-10(best)

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Korea Univ. Guro hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Keimyung University Hospital; 🇰🇷 Daegu, Korea, Republic of

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of

Wonju Severance Hospital; 🇰🇷 Wonju, Korea, Republic of

Catholic University college of medicine; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital, Yonsei University; 🇰🇷 Seoul, Korea, Republic of