UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059141 |
|---|---|
| Receipt number | R000067650 |
| Scientific Title | A Randomized Controlled Trial on Reducing Patient Anxiety and Predicting Heart Failure Exacerbation Using a Wearable Electrocardiogram Device |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/22 09:52:49 |
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Basic information
Public title
A Randomized Controlled Trial on Reducing Patient Anxiety and Predicting Heart Failure Exacerbation Using a Wearable Electrocardiogram Device
Acronym
WECare-HF trial (Wearable ECG to improve Care and predict deterioration in Heart Failure)
Scientific Title
A Randomized Controlled Trial on Reducing Patient Anxiety and Predicting Heart Failure Exacerbation Using a Wearable Electrocardiogram Device
Scientific Title:Acronym
A Randomized Controlled Trial on Reducing Patient Anxiety and Predicting Heart Failure Exacerbation Using a Wearable Electrocardiogram Device
Region
| Japan |
Condition
Condition
Cardiac Diseases
Classification by specialty
| Cardiology | Cardiovascular surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates whether ECG monitoring during daily activities at home using a wearable ECG device can alleviate patient anxiety and identify predictors of heart failure exacerbation. Specifically, it evaluates ECG monitoring during daily activities at home for two weeks post-discharge in cardiac patients using a wearable ECG device, focusing on the following aspects:
(1) Evaluate whether ECG monitoring at home contributes to improving patients' sense of security after discharge.
(2) Evaluate whether ECG monitoring information obtained at home can predict factors associated with worsening heart failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HADS (Hospital Anxiety and Depression Scale)
Key secondary outcomes
1) Exercise Self-Efficacy Scale
2) NT-proBNP
3) Presence or absence of readmission due to worsening heart failure, etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
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 noon the following day, one week later, and two weeks later. Additionally, spot measurements will be evaluated, such as attaching the device 5 minutes before starting daily activities like walking or shopping at home and removing it 5 minutes after the activity ends. Participants in the wearable ECG group will also record their lifestyle activities (sleep, meal, exercise, etc.) on a daily activity log. Analyzed ECG data will be provided as an analysis report via email attachment the day after discharge and one week later. The report will be handed out directly during the first outpatient visit. During the observation period, participants will receive occasional messages offering encouragement and reminding them to wear the ECG monitor.
Interventions/Control_2
Provide only standard discharge instructions
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key 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
Key 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.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
113-8421
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, 113-8421, JAPAN
TEL
03-3813-3111
te-takahashi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University
Division name
Faculty of Health Science
Zip code
113-0033
Address
3-2-12 Hongo, Bunkyo-ku, Tokyo, 113-0033, JAPAN
TEL
03-3812-1780
Homepage URL
te-takahashi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japan Keirin Autorace Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University, Research Ethics Committee
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, 113-8421, JAPAN
Tel
03-5802-1584
hongo-rinri@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067650
