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A Randomized Controlled Trial on Reducing Patient Anxiety and Predicting Heart Failure Exacerbation Using a Wearable Electrocardiogram Device

A Randomized Controlled Trial on Reducing Patient Anxiety and Predicting Heart Failure Exacerbation Using a Wearable Electrocardiogram Device - A Randomized Controlled Trial on Reducing Patient Anxiety and Predicting Heart Failure Exacerbation Using a Wearable Electrocardiogram Device

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059141
Enrollment
80
Registered
2025-10-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Diseases

Interventions

The wearable ECG group will be provided with a wearable ECG device and a smartphone with a dedicated app installed. ECG data during daily life will be collected from immediately after discharge until

Sponsors

Juntendo University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with heart disease who underwent cardiac rehabilitation at the Rehabilitation Department of Juntendo University Hospital during the study period 2. Individuals aged 20 to 90 years at the time of consent acquisition 3. Individuals who, after receiving sufficient explanation regarding participation in this study and demonstrating full understanding, provided their free and informed consent via SmartPRO electronic consent

Exclusion criteria

Exclusion criteria: 1. Individuals who experienced a serious cardiac event, such as cardiac arrest, during hospitalization 2. Individuals with low ADL who are not independent in daily living 3. Individuals who have difficulty operating a smartphone 4. Other individuals deemed unsuitable as research subjects by the principal investigator Eligibility is determined when an individual meets all (2) selection criteria and does not meet any (3) exclusion criteria among the (1) research subjects described above.

Design outcomes

Primary

MeasureTime frame
HADS (Hospital Anxiety and Depression Scale)

Secondary

MeasureTime frame
1) Exercise Self-Efficacy Scale 2) NT-proBNP 3) Presence or absence of readmission due to worsening heart failure, etc.

Countries

Japan

Contacts

Public ContactTetsuya Takahashi

Juntendo University Faculty of Health Science

te-takahashi@juntendo.ac.jp03-3812-1780

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026