Liver Transplant DisorderICMPNCT05953948
Effectiveness of Intelligent Case Manage Platform in Liver Transplant Recipients
A study testing Intelligent Case Manage Platform (ICMP) and self-management program in people with Liver Transplant Disorder and Self Efficacy, run by Chang Gung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Transplant Disorder, Self Efficacy, Quality of Life
- What is being tested?
- Intelligent Case Manage Platform (ICMP) and self-management program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver transplant recipients
- Age 20 years and above
- Ability to use smart-phone
Who cannot join
- liver encephalopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intelligent Case Manage Platform to Improve Self-management and Health-related Outcome Among Liver Transplant Recipients: Connection With Artificial Intelligence and Deep Learning
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.
Read the detailed description
Background: Liver transplant recipients require proper self-management to avoid the risk of various complications, reduce hospital readmission and medical costs, and improve their quality of life. They also face diverse challenges in self-management. Therefore, enhancing the self-management of liver transplant recipients after liver transplantation is important. Hospitals and medical facilities taking care of such patients should facilitate individualized care, access to healthcare resources, and planned post-discharge support. The use of information technology, artificial intelligence, and deep learning to identify and confirm the characteristics and types of self-management requirements of liver transplant recipients and provide individualized self-management may help improve their self-management skills and health outcomes. The quality and continuity of care can also be improved. However, no studies have been conducted in this regard.
Purpose: To establish an intelligent case management platform that combines artificial intelligence and deep learning to enhance the self-efficacy and self-management of liver transplant recipients, thereby improving clinical outcomes and health-related quality of life. 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 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.
Methods and materials: This study is a prospective, quasi-experimental design, with an experimental group and a control group, will be created. First, the self-management care and information needs of liver transplant patients will be integrated to create the foundation of the intelligent case management platform. For this purpose, an estimated 50 liver transplant recipients and 10 medical staff will be interviewed. The data will be analyzed by qualitative content analysis. Based on these contents, the intelligent case management platform will be developed and evaluated. For the evaluation, data from 200 liver transplant recipients will be collected to assess platform availability, performance, and usage status. Data related to the recipient's use of the platform and reception of self-management from the platform will also be collected for deep learning. The importance and clinical relevance of self-management provided by the platform will be assessed by the medical staff involved in liver transplant care. Deep learning techniques will be utilized, and the effectiveness of the intelligent case management platform in terms of self-efficacy, self-management, health outcomes, and health-related quality of life will be examined. An estimated 133 patients will be involved in this experiment: 44 in the experimental group and 89 in the control group. Data will be collected at discharge (baseline data) and 1, 3, 6, 9, and 12 months after discharge from the hospital. Statistical package software (SPSS 22.0) will be used to analyze the data. A generalized estimation equation model will analyze the differences in self-efficacy, self-management, and health-related quality of life over time between the experimental and control groups. This study proposes innovative applications for information technology, deep learning, and artificial intelligence. It is hoped that multidisciplinary cooperation can improve liver transplant recipients' self-management and health outcomes.
- Conditions
- Liver Transplant Disorder, Self Efficacy, Quality of Life
- Being tested
- Intelligent Case Manage Platform (ICMP) and self-management program
- Keywords
- liver transplantation, self-efficacy, self-management behavior, health-related quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent Case Manage Platform (ICMP) and self-management programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: Chang of the score from baseline health-related quality of life at 1, 3, 6, 9, and 12 months after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 333 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weng, Li-Chueh, Chang Gung University
- Investigators
- Li-Chueh Weng, PHD, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953948
- Sponsor's protocol ID
- ICMP20230704
- Acronym
- ICMP
- Status last verified
- Mar 2026
- First submitted
- 3 Jul 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We could not share the individual data because of the privacy.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Case Manage Platform to Improve Self-management and Health-related Outcome Among Liver Transplant Recipients: Connection With Artificial Intelligence and Deep Learning
- ClinicalTrials.gov ID
- NCT05953948
- Acronym / sponsor ID
- ICMP / ICMP20230704
- Conditions
- Liver Transplant Disorder, Self Efficacy, Quality of Life
- Keywords
- liver transplantation, self-efficacy, self-management behavior, health-related quality of life
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 333 participants (estimated)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Liver transplant recipients require proper self-management to avoid the risk of various complications, reduce hospital readmission and medical costs, and improve their quality of life. They also face diverse challenges in self-management. Therefore, enhancing the self-management of liver transplant recipients after liver transplantation is important. Hospitals and medical facilities taking care of such patients should facilitate individualized care, access to healthcare resources, and planned post-discharge support. The use of information technology, artificial intelligence, and deep learning to identify and confirm the characteristics and types of self-management requirements of liver transplant recipients and provide individualized self-management may help improve their self-management skills and health outcomes. The quality and continuity of care can also be improved. However, no studies have been conducted in this regard.
Purpose: To establish an intelligent case management platform that combines artificial intelligence and deep learning to enhance the self-efficacy and self-management of liver transplant recipients, thereby improving clinical outcomes and health-related quality of life. 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 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.
Methods and materials: This study is a prospective, quasi-experimental design, with an experimental group and a control group, will be created. First, the self-management care and information needs of liver transplant patients will be integrated to create the foundation of the intelligent case management platform. For this purpose, an estimated 50 liver transplant recipients and 10 medical staff will be interviewed. The data will be analyzed by qualitative content analysis. Based on these contents, the intelligent case management platform will be developed and evaluated. For the evaluation, data from 200 liver transplant recipients will be collected to assess platform availability, performance, and usage status. Data related to the recipient's use of the platform and reception of self-management from the platform will also be collected for deep learning. The importance and clinical relevance of self-management provided by the platform will be assessed by the medical staff involved in liver transplant care. Deep learning techniques will be utilized, and the effectiveness of the intelligent case management platform in terms of self-efficacy, self-management, health outcomes, and health-related quality of life will be examined. An estimated 133 patients will be involved in this experiment: 44 in the experimental group and 89 in the control group. Data will be collected at discharge (baseline data) and 1, 3, 6, 9, and 12 months after discharge from the hospital. Statistical package software (SPSS 22.0) will be used to analyze the data. A generalized estimation equation model will analyze the differences in self-efficacy, self-management, and health-related quality of life over time between the experimental and control groups. This study proposes innovative applications for information technology, deep learning, and artificial intelligence. It is hoped that multidisciplinary cooperation can improve liver transplant recipients' self-management and health outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intelligent case manage platform (ICMP) and self-management program | Experimental | Other: Intelligent Case Manage Platform (ICMP) and self-management programThe 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. |
| usual care | No intervention | –Participants in the control only received the usual care that included wound care, medication, and infection control. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Liver transplant recipients
- Age 20 years and above
- Ability to use smart-phone
Key exclusion criteria (1 listed)
- liver encephalopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intelligent Case Manage Platform (ICMP) and self-management programThis 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. | Other | Intelligent case manage platform (ICMP) and self-management program |
Primary outcome
Change of the score of self-management behavior
Time frame: 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-management behavior related to the care after liver transplantation assessed by the Self-Management Behavior Scale
Change of the score of self-efficacy
Time frame: Chang of the score from baseline self-efficacy at 1, 3, 6, 9, and 12 months after liver transplantation
Change of the score of self-efficacy about manage the condition after liver transplantation assessed by the Self-Efficacy Scale
Change of the score of health-related quality of life
Time frame: Chang of the score from baseline health-related quality of life at 1, 3, 6, 9, and 12 months after liver transplantation
Change of the score of health-related quality of life assessed by the questionnaire of Medical Outcome Survey - Short Form 12 (MOS SF-12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No. We could not share the individual data because of the privacy.
Related trials for Liver Transplant Disorder
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li-Chueh Weng, PHD principal investigator
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent Case Manage Platform (ICMP) and self-management program in people with Liver Transplant Disorder and Self Efficacy, run by Chang Gung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the score of self-management behavior (time frame: Chang of the score from baseline self-management behavior at 1, 3, 6, 9, and 12 months after liver transplantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.