- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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:
- 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?
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tung Hung Su, MD, PhD
- Phone Number: 886-972651694
- Email: tunghungsu@gmail.com
Study Locations
-
-
-
Taipei, Taiwan, 100
- National Taiwan University Hospital
-
Contact:
- Tung-Hung Su
- Phone Number: 886-972651694
- Email: tunghungsu@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telemedicine care
Telemedice care platform
|
|
|
No Intervention: Starndard Helath Care
Standard health care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Liver Disease Severity Scores
Time Frame: 12 months
|
MELD 3.0 score
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 months
|
|
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.
|
12 months
|
|
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.
|
12 months
|
|
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".
|
12 months
|
|
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
|
12 months
|
|
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)
|
12 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202410060RINC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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