Decompensated Cirrhosis of Liver
Conditions
Keywords
decompensated cirrhosis, telemedicine, digital medicine, mobile health, prognosis, health care
Brief summary
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: 1. Does this telemedicine model lower the number of cirrhosis-related hospitalizations and emergency department visits? 2. Does the model reduce medical expenses and improve disease outcomes compared to standard care? 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: 1. Use the NTUH telehealth platform (NTUH-TPC) to access records and upload physiological, medical, and imaging data. 2. Wear a smart watch for remote physiological monitoring. Receive continuous remote care and proactive follow-ups from case managers.
Interventions
DEVICETelemedicine care
1. NTUH telehealth platform for cirrhosis, NTUH-TPC 2. Provide a wearable device (Asus vivowatch 6 aero) 3. Telemonitoring by case manager 4. Self-reported information from enrolled patients
Sponsors
National Taiwan University Hospital
National Science and Technology Council, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with decompensated cirrhosis and a Child score of B or C 2. Age: 18 years or older 3. Must return for a follow-up visit at least every 3 months
Exclusion criteria
1. Patients with active malignant tumors (those with a history of malignant tumors must have been cured for at least 2 years) 2. Patients with an expected survival of less than one year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Liver Disease Severity Scores | 12 months | MELD 3.0 score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of All-Cause Unplanned Hospitalizations | 12 months | It measures how frequently participants are admitted to the hospital for any unexpected medical reason over a 12-month period. |
| Rate of All-Cause Unplanned Emergency Room Visits | 12 months | The study tracks every instance a participant visits the Emergency Room (ER) for an unscheduled medical issue over a 12-month period. |
| Days alive and out of hospital | 12 months | 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. |
| Quality of Life Score & Patient Satisfaction | 12 months | 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". |
| Feasibility and Adherence to telemedicine | 12 months | Percentage of days with successful vital sign uploads (smartwatch) and response rate to case manager calls |
| Total medical expenses at NTUH related to cirrhosis | 12 months | This metric tracks the overall financial cost of healthcare provided specifically for liver disease throughout the study period. (Outpatient + ER + Inpatient) |
Countries
Taiwan
Contacts
CONTACTTung Hung Su, MD, PhD
Outcome results
None listed