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NCT Number: NCT07439770

Using Telemedicine to Assist in the Clinical Care of Patients With Decompensated Cirrhosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Telemedicine care

Device
  • 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

Primary outcomes

  1. Change in Liver Disease Severity Scores

    Time frame: 12 months

    MELD 3.0 score

Secondary outcomes

  1. Rate of All-Cause Unplanned Hospitalizations

    Time frame: 12 months

    It measures how frequently participants are admitted to the hospital for any unexpected medical reason over a 12-month period.

  2. Rate of All-Cause Unplanned Emergency Room Visits

    Time frame: 12 months

    The study tracks every instance a participant visits the Emergency Room (ER) for an unscheduled medical issue over a 12-month period.

  3. Days alive and out of hospital

    Time frame: 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.

  4. Quality of Life Score & Patient Satisfaction

    Time frame: 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".

  5. Feasibility and Adherence to telemedicine

    Time frame: 12 months

    Percentage of days with successful vital sign uploads (smartwatch) and response rate to case manager calls

  6. Total medical expenses at NTUH related to cirrhosis

    Time frame: 12 months

    This metric tracks the overall financial cost of healthcare provided specifically for liver disease throughout the study period. (Outpatient + ER + Inpatient)

Study contacts

Contact information is provided by the study sponsor or research team.

Tung Hung Su, MD, PhD

CONTACT

[email protected]

886-972651694

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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