Effectiveness of Intelligent Case Manage Platform in Liver Transplant Recipients

NCT05953948 | Enrolling By Invitation

• 1 other identifier: ICMP20230704
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, quasi-experimental design, with an experimental group and a control group, will be created. The aims of this study are as follows: 1. Describe the self-management and information needs of liver transplant recipients, 2. Create content or modules related to the self-management of liver transplant recipients, 3. Build an intelligent case management platform, 4. Evaluate the usability of the platform, and 5. Conduct deep learning and examine the effects of the intelligent case management platform on self-efficacy, self-management, health outcomes, and health-related quality of life. Data will be collected at discharge (baseline data) and 1, 3, 6, 9, and 12 months after discharge. An estimated 133 patients will be involved in this experiment: 44 in the experimental group and 89 in the control group. Statistical package software (SPSS 22.0) will be used to analyze the data. A generalized estimation equation model will examine the differences in self-efficacy, self-management, and health-related quality of life between the experimental and control groups. Survival analysis and the Kaplan-Meier method will be used to analyze health outcomes, including hospital readmission, emergency visits, episodes of infection and rejection of organs, and death.

Conditions

Quality of Life; Liver Transplant Disorder; Self Efficacy

Keywords

liver transplantation; self-efficacy; self-management behavior; health-related quality of life

Outcome Measures

Primary Outcomes (3)

• Change of the score of self-management behavior

  Change of the score of self-management behavior related to the care after liver transplantation assessed by the Self-Management Behavior Scale

  Chang of the score from baseline self-management behavior at 1, 3, 6, 9, and 12 months after liver transplantation

• Change of the score of self-efficacy

  Change of the score of self-efficacy about manage the condition after liver transplantation assessed by the Self-Efficacy Scale

  Chang of the score from baseline self-efficacy at 1, 3, 6, 9, and 12 months after liver transplantation

• Change of the score of health-related quality of life

  Change of the score of health-related quality of life assessed by the questionnaire of Medical Outcome Survey - Short Form 12 (MOS SF-12)

  Chang of the score from baseline health-related quality of life at 1, 3, 6, 9, and 12 months after liver transplantation

Study Arms (2)

Intelligent case manage platform (ICMP) and self-management program

EXPERIMENTAL

The experimental group received ICMP information. They could interact with the care manager via chatbot. The ICMP was established with information related to care instruction after liver transplantation.

Other: Intelligent Case Manage Platform (ICMP) and self-management program

usual care

NO INTERVENTION

Participants in the control only received the usual care that included wound care, medication, and infection control.

Interventions

Intelligent Case Manage Platform (ICMP) and self-management program OTHER

This platform includes information and instruction related to the care of liver transplantation. Participants could gain knowledge and skill to manage their conditions after liver transplantation.

Intelligent case manage platform (ICMP) and self-management program

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver transplant recipients
• Age 20 years and above
• Ability to use smart-phone

You may not qualify if:

• liver encephalopathy

Sponsors & Collaborators

• Chang Gung University: lead

Study Sites (1)

Chang Gung University

Taoyuan District, TY, 33302, Taiwan

Location

MeSH Terms

Interventions

Self-Management

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Li-Chueh Weng, PHD

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study participants will be aware they are in the experimental or control group; however, the data collector did not know which group the participants are in.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: In the feasibility evaluation stage, 200 patients will be recruited for the study. In the quasi-experiment stage, 133 patients will be involved in this experiment: 44 in the experimental group and 89 in the control group. The intervention or usual care will conduct parallel.

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 20, 2023
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)