Mobile App for Heart Failure

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05668000
• Collaborator: KT Corporation (Industry)
• Enrollment: 84
• Locations: 7
• Arms: 2
• Anticipated Duration (Months): 3.4
• Patients Per Site: 12
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: Mobile application with device; Other: Mobile application	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Self-Monitoring Using Mobile App for Reduction of Rehospitalization and Mortality in Heart Failure (SMART-HF)
• Actual Study Start Date: Oct 19, 2022
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AIDA/KT-app with devices AIDA/KT-app with devices : with device link and with feedback	Other: Mobile application with device; AIDA/KT-app with devices: The mobile application provide self-management interventions with devices including sphygomanometer and body water meter.; Other: Mobile application; The mobile application provide 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 self-management interventions.

Outcome Measures

Primary Outcome Measures

1. 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)

2. HF symptom by questionnaire [4 weeks]

   The degree of dyspnea will be evaluated by questionnaire. Range: 0(worst)-10(best)

Secondary Outcome Measures

1. Composite outcome [4 weeks]

   including death, rehospitalization, and unscheduled HF visit, which will be analyzed using a win ratio

2. Application satisfaction score [4 weeks]

   The satisfaction score will be evaluated by questionnaire. Range: 0(worst)-10(best)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keimyung University Hospital	Daegu		Korea, Republic of
2	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of
3	Catholic University college of medicine	Seoul		Korea, Republic of
4	Korea Univ. Guro hospital	Seoul		Korea, Republic of
5	Samsung medical center	Seoul		Korea, Republic of
6	Severance Hospital, Yonsei University	Seoul		Korea, Republic of
7	Wonju Severance Hospital	Wonju		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Bundang Hospital
• KT Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dong-Ju Choi, Professor, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT05668000
• Other Study ID Numbers: SMART-HF
• First Posted: Dec 29, 2022
• Last Update Posted: Jan 3, 2023
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Jan 3, 2023