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Not yet recruiting NCT07439770

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

No phase Interventional Decompensated Cirrhosis of Liver

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Telemedicine care.
Who it may be relevant to
Registry conditions: Decompensated Cirrhosis of Liver. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Device Telemedicine 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

Primary outcome measures

  • Change in Liver Disease Severity Scores [Time frame: 12 months]
Secondary outcome measures (6)
  • Rate of All-Cause Unplanned Hospitalizations [Time frame: 12 months]
  • Rate of All-Cause Unplanned Emergency Room Visits [Time frame: 12 months]
  • Days alive and out of hospital [Time frame: 12 months]
  • Quality of Life Score & Patient Satisfaction [Time frame: 12 months]
  • Feasibility and Adherence to telemedicine [Time frame: 12 months]
  • Total medical expenses at NTUH related to cirrhosis [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT07439770 · 202410060RINC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗