Heart FailureNCT05668000
Mobile App for Heart Failure
A study testing Bluetooth-connected monitoring devices and a feedback system and Mobile application in people with Heart Failure, run by Seoul National University Bundang Hospital at 7 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Bluetooth-connected monitoring devices and a feedback system and Mobile application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 19 Oct 2022to 26 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Keimyung University Hospital
Daegu
Seoul National University Bundang Hospital
Seongnam
Catholic University college of medicine
Seoul
Korea Univ. Guro hospital
Seoul
Samsung medical center
Seoul
Severance Hospital, Yonsei University
Seoul
Wonju Severance Hospital
Wŏnju
About this study
Official title: Self-Monitoring Using Mobile App for Reduction of Rehospitalization and Mortality in Heart Failure (SMART-HF)
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.
- Conditions
- Heart Failure
- Being tested
- Bluetooth-connected monitoring devices and a feedback system, Mobile application
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bluetooth-connected monitoring devices and a feedback systemOther
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 applicationOther
The mobile application provide only self-management interventions.
| Study group | Role | What they receive |
|---|---|---|
| AIDA/KT-app with devices | Experimental | AIDA/KT-app with devices : with device link and with feedback Receives: Other: Bluetooth-connected monitoring devices and a feedback system; Other: Mobile application |
| AIDA/KT-app only | Placebo comparator | AIDA/KT-app only : no device link or no feedback Receives: Other: Mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 weeks
HF symptom by questionnaire
The degree of dyspnea will be evaluated by questionnaire. Range: 0(worst)-10(best)
Measured: 4 weeks
Secondary outcomes (3)
Composite outcome
including death, rehospitalization, and unscheduled HF visit
Measured: 4 weeks
Application satisfaction score
The satisfaction score will be evaluated by questionnaire. Range: 0(worst)-10(best)
Measured: 4 weeks
change in body water composition f
the change in body water composition from baseline to the last measurement in the intervention group
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start19 Oct 2022
- Primary completion26 Jan 2023
- Study completion26 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KT Corporation
- Responsible party
- Principal investigator, Dong-Ju Choi, Seoul National University Bundang Hospital
- Investigators
- Dong-Ju Choi, Study chair, Seoul National Univeristy Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668000
- Sponsor's protocol ID
- SMART-HF
- Status last verified
- Oct 2023
- First submitted
- 19 Dec 2022
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoon M, Lee S, Choi JY, Jung MH, Youn JC, Shim CY, Choi JO, Kim EJ, Kim H, Yoo BS, Son YJ, Choi DJ. Effectiveness of a Smartphone App-Based Intervention With Bluetooth-Connected Monitoring Devices and a Feedback System in Heart Failure (SMART-HF Trial): Randomized Controlled Trial. J Med Internet Res. 2024 Apr 29;26:e52075. doi: 10.2196/52075.
PubMed 38683665
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Monitoring Using Mobile App for Reduction of Rehospitalization and Mortality in Heart Failure (SMART-HF)
- ClinicalTrials.gov ID
- NCT05668000
- Acronym / sponsor ID
- SMART-HF
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- KT Corporation
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIDA/KT-app with devices | Experimental | Other: Bluetooth-connected monitoring devices and a feedback system, Other: Mobile applicationAIDA/KT-app with devices : with device link and with feedback |
| AIDA/KT-app only | Placebo comparator | Other: Mobile applicationAIDA/KT-app only : no device link or no feedback |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bluetooth-connected monitoring devices and a feedback systemAIDA/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 | Other | AIDA/KT-app with devices |
| Mobile applicationThe mobile application provide only self-management interventions. | Other | AIDA/KT-app only, AIDA/KT-app with devices |
Primary outcome
HF symptom by application scores.
Time frame: 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
Time frame: 4 weeks
The degree of dyspnea will be evaluated by questionnaire. Range: 0(worst)-10(best)
3 secondary outcomes
Composite outcome
Time frame: 4 weeks
Application satisfaction score
Time frame: 4 weeks
change in body water composition f
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Derived from this study: PubMed 38683665Yoon M, Lee S, Choi JY, Jung MH, Youn JC, Shim CY, Choi JO, Kim EJ, Kim H, Yoo BS, Son YJ, Choi DJ. Effectiveness of a Smartphone App-Based Intervention With Bluetooth-Connected Monitoring Devices and a Feedback System in Heart Failure (SMART-HF Trial): Randomized Controlled Trial. J Med Internet Res. 2024 Apr 29;26:e52075. doi: 10.2196/52075.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-Ju Choi study chair
Seoul National Univeristy Bundang Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bluetooth-connected monitoring devices and a feedback system and Mobile application in people with Heart Failure, run by Seoul National University Bundang Hospital at 7 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HF symptom by application scores. (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05668000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.