Home-based Remote Monitoring
NCT05295303 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 344
Last updated 2022-03-25
Summary
Acute myocardial infarction (MI) is a disease of high morbidity and mortality. It is usually caused by atherothrombosis of major epicardial coronary arteries which result in myocardial necrosis. Due to improvement in care systems, availability of revascularizations and better medical treatment, the mortality of MI has generally declined in the past 20 years. Nevertheless, patients survived MI are still at heightened risk of further cardiovascular events and death. Therefore, guideline directed secondary preventive measures are of paramount importance to improve long term outcome. These include adherence to medications and dose titration, risk factor modification, detection of arrhythmia and use of implantable cardio-defibrillator (ICD) as appropriate. In reality, guideline adherence is unsatisfactory and may lead to worse clinical outcomes. The underlying reasons are multi-factorial, including lack of patient education, recognition, motivation or physician inertia. Therefore, newer initiatives are required to reinforce secondary preventive measures.
In current era of health information technology, remote monitoring and telecommunication emerge to be practice-changing in various aspects of healthcare provision. Particularly for post MI survivors, the early post discharge period is vulnerable and a significant number of patients are readmitted 30 days after leaving hospital. This is not surprising as patients are still in recovering phase on medications titration and many of them may not fully accept they are suffering from a life-threatening condition. Besides, malignant arrhythmia may develop without the protection of ICD which is usually implanted after 40 days post MI as per clinical guidelines. As such, home-based remote monitoring with handheld single-lead electrocardiogram and patch-based continuous holter monitor can potentially detect arrhythmia which prompt early clinical attention. Furthermore, daily blood pressure measurement using dedicated smartphone applications enables physicians and patients to up-titrate medications to desired doses more quickly. This can hopefully strengthen compliance to better achieve guideline recommended treatment targets.
In the Quality Improvements in Post-Myocardial Infarction Management using Home-Based RemOte Monitoring System trial (QIBO; "岐伯" in Chinese), we investigate the feasibility and efficacy of utilizing a home-based remote monitoring system in post MI survivors. We hypothesize that this approach is effective to improve guideline directed treatment utility, cardiovascular risk factors target achievement and clinical outcome.
Conditions
Interventions
- DEVICE
-
Remote integrated post-MI management system
The home-based remote integrated post-MI management system comprises (1) a patch-based long-term Holter monitoring system HC3A250 (BISA Technologies (Hong Kong) Limited, Hong Kong SAR, China), (2) a handheld single-lead electrocardiogram (ECG) recorder (Comfit Healthcare Devices Limited, Hong Kong SAR, China), (3) a blood pressure monitor, (4) a patient-facing smartphone application specially designed for the study, and (5) a web-based clinical management system for clinicians
Sponsors & Collaborators
-
The University of Hong Kong
lead OTHER
Principal Investigators
-
Chung-Wah David Siu, Prof · The University of Hong Kong
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-01
- Primary Completion
- 2025-06-30
- Completion
- 2026-06-30
Countries
- Hong Kong
Study Locations
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