Improving Healthcare Outcomes With Early Detection of Liver Related Complications in Liver Cirrhosis Patients by Implementing a Telemedicine Care Pathway (myLIVERcoach)

NCT07376967 | Completed

• 1 other identifier: METC 2022-3567
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this multicenter feasibility study is to investigate the feasibility of our telemedicine platform (myLIVERcoach) in liver cirrhosis patients, according to liver cirrhosis patients, caregivers and healthcare professionals. The main question\[s\] it aims to answer are:

1. 1.What is the feasibility of a telemonitoring pathway according to patients, caregivers and healthcare professionals in liver cirrhosis care?
2. 2.What is the level of acceptability, usability, learnability and desirability of a telemonitoring pathway in liver cirrhosis care from the patients, caregivers and healthcare professionals' perspective?
3. 3.What is the level of compliance of patients, caregivers and healthcare professionals using a telemonitoring pathway in liver cirrhosis care?
4. 4.What is the occurrence of liver related complications in liver cirrhosis patients using a telemonitoring pathway?
5. 5.What is the occurrence of clinical admissions and emergency concultations in liver cirrhosis patients using a telemonitoring pathway?
6. 6.What is the mortality rate in liver cirrhosis patients using a telemonitoring pathway?

Conditions

Liver Cirrhosis

Keywords

Telemedicine; eHealth; Telemonitoring; mobile health

Outcome Measures

Primary Outcomes (1)

• Feasibility defined by the number of recommendations to use this telemonitoring pathway by patients, caregivers and healthcare profesionals.

  A score of ≥4.0 in ≥70% of patients, caregivers and healthcare professionals together will be defined as feasible. Using a likert scale, minimum value 1 (worst), maximum value 5 (best) Results of the question ''I would recommend the application to others'', see appendix B. A score ≥4.0 in ≥70% of patients, caregivers and healthcare professionals together is defined as significant satisfaction, one of the main aspects of adequate feasibility.

  6 months

Secondary Outcomes (9)

• Compliance defined by ≥70% initiated questionnaires and e-learnings of actual provided questionnaires and e-learnings.

  6 months

• Compliance defined by ≥70% completed questionnaires and e-learnings of actual provided questionnaires and e-learnings.

  6 months

• Usability defined as a mean score of ≥4.0 in ≥70% patients, caregivers, and healthcare professionals together in the question ''It was easy to indicate my complaints with myLIVERcoach.''

  6 months

• Learnability defined as a mean score of ≥4.0 in ≥70% patients, caregivers, and healthcare professionals together in the question ''It was easy to learn how I had to use myLIVERcoach''.

  6 months

• Desirability defined as a mean score of ≥4.0 in ≥70% patients, caregivers, and healthcare professionals togethe in the question ''MyLIVERcoach meets my approval.''

  6 months

Study Arms (1)

Patients using telemedicine on top of standard care

OTHER

Device: telemedicine pathway

Interventions

telemedicine pathway DEVICE

Patients are able to use an online application on top of standard care. Monitoring complications, subjective wellbeing and lifestyle factors. Patients are able to go through information about liver cirrhosis and additional aspects, like dietary advices, at any moment in time. Furthermore, they are able to contact their healthcare professional through the chat function.

Patients using telemedicine on top of standard care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years of age or caregiver of a patient (both ≥ 18 years of age)
• Liver cirrhosis, based on biopsy, fibroscan or diagnostic imaging data or caregiver of a patient with this diagnosis

You may not qualify if:

• Inability to read or understand informed consent
• Lack of internet access
• History of or current hepatocellular carcinoma
• History of or current hepatic metastasis
• History of liver transplantation

Sponsors & Collaborators

• Dutch Digestive Diseases Foundation: collaborator
• Maastricht University Medical Center: collaborator
• Maastricht University: lead
• Gelre Hospitals: collaborator

Study Sites (2)

Gelre Ziekenhuizen

Apeldoorn, Gelderland, 7334 DZ, Netherlands

Location

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: January 29, 2026
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 29, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)