NCT07439770

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. 1.Does this telemedicine model lower the number of cirrhosis-related hospitalizations and emergency department visits?
  2. 2.Does the model reduce medical expenses and improve disease outcomes compared to standard care?
  3. 3.Use the NTUH telehealth platform (NTUH-TPC) to access records and upload physiological, medical, and imaging data.
  4. 4.Wear a smart watch for remote physiological monitoring. Receive continuous remote care and proactive follow-ups from case managers.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
33mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Feb 2026Dec 2028

First Submitted

Initial submission to the registry

February 1, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

February 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.9 years

First QC Date

February 1, 2026

Last Update Submit

February 23, 2026

Conditions

Keywords

decompensated cirrhosistelemedicinedigital medicinemobile healthprognosishealth care

Outcome Measures

Primary Outcomes (1)

  • Change in Liver Disease Severity Scores

    MELD 3.0 score

    12 months

Secondary Outcomes (6)

  • Rate of All-Cause Unplanned Hospitalizations

    12 months

  • Rate of All-Cause Unplanned Emergency Room Visits

    12 months

  • Days alive and out of hospital

    12 months

  • Quality of Life Score & Patient Satisfaction

    12 months

  • Feasibility and Adherence to telemedicine

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Telemedicine care

EXPERIMENTAL

Telemedice care platform

Device: Telemedicine care

Starndard Helath Care

NO INTERVENTION

Standard health care

Interventions

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

Telemedicine care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Central Study Contacts

Tung Hung Su, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2026

First Posted

February 27, 2026

Study Start

February 23, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

To protect the patients' privacy information.

Locations