Mobile App for Heart Failure

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Bluetooth-connected monitoring devices and a feedback system
* Other: Mobile application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIDA/KT-app with devices<br>AIDA/KT-app with devices : with device link and with feedback | Other: Bluetooth-connected monitoring devices and a feedback system<br>* 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<br>Other: Mobile application<br>* The mobile application provide only self-management interventions.<br>|
| Placebo Comparator: AIDA/KT-app only<br>AIDA/KT-app only : no device link or no feedback | Other: Mobile application<br>* The mobile application provide only self-management interventions.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| Composite outcome | including death, rehospitalization, and unscheduled HF visit | 4 weeks | 
| Application satisfaction score | The satisfaction score will be evaluated by questionnaire. Range: 0(worst)-10(best) | 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 |