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Mobile App for Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mobile application with device
Mobile application
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keimyung University Hospital
  • Seoul National University Bundang Hospital
  • Catholic University college of medicine
  • Korea Univ. Guro hospital
  • Samsung medical center
  • Severance Hospital, Yonsei University
  • Wonju Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AIDA/KT-app with devices

AIDA/KT-app only

Arm Description

AIDA/KT-app with devices : with device link and with feedback

AIDA/KT-app only : no device link or no feedback

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Composite outcome
including death, rehospitalization, and unscheduled HF visit, which will be analyzed using a win ratio
Application satisfaction score
The satisfaction score will be evaluated by questionnaire. Range: 0(worst)-10(best)

Full Information

First Posted
December 19, 2022
Last Updated
June 29, 2023
Sponsor
Seoul National University Bundang Hospital
Collaborators
KT Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05668000
Brief Title
Mobile App for Heart Failure
Official Title
Self-Monitoring Using Mobile App for Reduction of Rehospitalization and Mortality in Heart Failure (SMART-HF)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
January 26, 2023 (Actual)
Study Completion Date
January 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
KT Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AIDA/KT-app with devices
Arm Type
Experimental
Arm Description
AIDA/KT-app with devices : with device link and with feedback
Arm Title
AIDA/KT-app only
Arm Type
Placebo Comparator
Arm Description
AIDA/KT-app only : no device link or no feedback
Intervention Type
Other
Intervention Name(s)
Mobile application with device
Intervention Description
AIDA/KT-app with devices: The mobile application provide self-management interventions with devices including sphygomanometer and body water meter.
Intervention Type
Other
Intervention Name(s)
Mobile application
Intervention Description
The mobile application provide self-management interventions.
Primary Outcome Measure Information:
Title
HF symptom by application scores.
Description
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)
Time Frame
4 weeks
Title
HF symptom by questionnaire
Description
The degree of dyspnea will be evaluated by questionnaire. Range: 0(worst)-10(best)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Composite outcome
Description
including death, rehospitalization, and unscheduled HF visit, which will be analyzed using a win ratio
Time Frame
4 weeks
Title
Application satisfaction score
Description
The satisfaction score will be evaluated by questionnaire. Range: 0(worst)-10(best)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Ju Choi
Organizational Affiliation
Seoul National Univeristy Bundang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Keimyung University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Catholic University college of medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Korea Univ. Guro hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung medical center
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University
City
Seoul
Country
Korea, Republic of
Facility Name
Wonju Severance Hospital
City
Wonju
Country
Korea, Republic of

12. IPD Sharing Statement

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Mobile App for Heart Failure

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