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

N/ANot Yet RecruitingNCT07439770

National Taiwan University Hospital120 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

120

Conditions

Decompensated Cirrhosis of Liver

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Change in Liver Disease Severity Scores

MELD 3.0 score

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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".

Time frame: 12 months

Feasibility and Adherence to telemedicine

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

Time frame: 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)

Time frame: 12 months

Central Contacts

Tung Hung Su, MD, PhD

CONTACT

886-972651694 tunghungsu@gmail.com

Data from ClinicalTrials.gov

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