Mobile App for Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05668000
• Other study ID #: SMART-HF
• Status: Completed
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: January 26, 2023

Study information

• Verified date: October 2023
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 26, 2023
• Est. primary completion date: January 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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
• Mobile application
The mobile application provide only self-management interventions.

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	KT Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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