Decompensated Cirrhosis of LiverNCT07439770
Using Telemedicine to Assist in the Clinical Care of Patients With Decompensated Cirrhosis
A study testing Telemedicine care in people with Decompensated Cirrhosis of Liver, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Cirrhosis of Liver
- What is being tested?
- Telemedicine care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Feb 2026to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with decompensated cirrhosis and a Child score of B or C
- Age: 18 years or older
- Must return for a follow-up visit at least every 3 months
Who cannot join
- Patients with active malignant tumors (those with a history of malignant tumors must have been cured for at least 2 years)
- Patients with an expected survival of less than one year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Taiwan University Hospital
Taipei, 100
Tung-Hung Su, 886-972651694, tunghungsu@gmail.com
About this study
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:
- Does this telemedicine model lower the number of cirrhosis-related hospitalizations and emergency department visits?
- Does the model reduce medical expenses and improve disease outcomes compared to standard care?
Read more
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:
- Use the NTUH telehealth platform (NTUH-TPC) to access records and upload physiological, medical, and imaging data.
- Wear a smart watch for remote physiological monitoring. Receive continuous remote care and proactive follow-ups from case managers.
- Conditions
- Decompensated Cirrhosis of Liver
- Being tested
- Telemedicine care
- Keywords
- decompensated cirrhosis, telemedicine, digital medicine, mobile health, prognosis, health care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine careDevice
- NTUH telehealth platform for cirrhosis, NTUH-TPC
- Provide a wearable device (Asus vivowatch 6 aero)
- Telemonitoring by case manager
- Self-reported information from enrolled patients
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine care | Experimental | Telemedice care platform Receives: Device: Telemedicine care |
| Starndard Helath Care | No intervention | Standard health care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Liver Disease Severity Scores
MELD 3.0 score
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 12 months
Rate of All-Cause Unplanned Emergency Room Visits
The study tracks every instance a participant visits the Emergency Room (ER) for an unscheduled medical issue over a 12-month period.
Measured: 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.
Measured: 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".
Measured: 12 months
Feasibility and Adherence to telemedicine
Percentage of days with successful vital sign uploads (smartwatch) and response rate to case manager calls
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start23 Feb 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated Cirrhosis of LiverStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439770
- Sponsor's protocol ID
- 202410060RINC
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the patients' privacy information.