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| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
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The goal of this clinical trial is to learn if an integrated digital and telemedicine care model works to manage decompensated cirrhosis in patients. It will also learn about the impact of this model on healthcare resource consumption and patient quality of life. The main questions it aims to answer are:
Researchers will compare the digital telemedicine care model (utilizing the NTUH-TPC platform and wearable devices) to standard health care to see if the digital approach effectively reduces hospital admissions and medical costs.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine care | Experimental | Telemedice care platform |
|
| Starndard Helath Care | No Intervention | Standard health care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine care | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Liver Disease Severity Scores | MELD 3.0 score | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of All-Cause Unplanned Hospitalizations | It measures how frequently participants are admitted to the hospital for any unexpected medical reason over a 12-month period. | 12 months |
| Rate of All-Cause Unplanned Emergency Room Visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tung Hung Su, MD, PhD | Contact | 886-972651694 | tunghungsu@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
To protect the patients' privacy information.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2026 | Feb 1, 2026 | Prot_SAP_000.pdf |
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The study tracks every instance a participant visits the Emergency Room (ER) for an unscheduled medical issue over a 12-month period.
| 12 months |
| Days alive and out of hospital | This metric is a patient-centered outcome used to measure the total amount of time a participant spends healthy and at home, rather than in a hospital or losing life due to disease. | 12 months |
| Quality of Life Score & Patient Satisfaction | This composite metric measures how the clinical trial's care models affect the daily well-being, emotional state, and overall happiness of patients living with advanced liver disease. By using thise two questionnaries "CLDQ" and "EQ-5D-5L". | 12 months |
| Feasibility and Adherence to telemedicine | Percentage of days with successful vital sign uploads (smartwatch) and response rate to case manager calls | 12 months |
| Total medical expenses at NTUH related to cirrhosis | This metric tracks the overall financial cost of healthcare provided specifically for liver disease throughout the study period. (Outpatient + ER + Inpatient) | 12 months |