Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059141) titled 'A Randomized Controlled Trial on Reducing Patient Anxiety and Predicting Heart Failure Exacerbation Using a Wearable Electrocardiogram Device' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - Juntendo University
Condition:
Condition - Cardiac Diseases
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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
Eligibility:
Age-lower limit - 20
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 Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 18 Day
Anticipated trial start date - 2025 Year 10 Month 01 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067650
Disclaimer: Curated by HT Syndication.
