An interventional study of AI Agent-Assisted Proactive Management and Standard Care in Decompensated Liver Cirrhosis, sponsored by Beijing Tsinghua Chang Gung Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Beijing Tsinghua Chang Gung Hospital · Not applicable, Interventional, and Prevention
This study will compare two ways of supporting adults with cirrhosis after they leave hospital. Cirrhosis is severe scarring of the liver. Eligible participants will have been hospitalized for liver-related complications and will be ready for discharge. The main question is whether adding an artificial intelligence (AI)-assisted management service to usual care reduces unplanned hospital care caused by worsening liver disease during the next 90 days.
The study plans to enroll 180 adults at three centers. Participants will be assigned by chance, with an equal chance of receiving usual care alone or usual care plus AI-assisted proactive management. Participants receiving the additional service, or their authorized caregivers, will complete a brief daily health report taking about 3-5 minutes and may report symptoms when they occur. The system helps organize reports and identify information requiring attention. Nurses check the information, and physicians make clinical decisions. The system does not independently diagnose illness, prescribe treatment, or change medication.
Both groups will continue their usual medical care and have study follow-up contacts on days 7, 30, 60, and 90. The study will compare unplanned emergency visits, hospital observation, acute same-day treatment, and readmissions related to worsening liver disease. Safety and the burden of using and delivering the service will also be assessed. Participants with urgent symptoms should seek emergency care without waiting for a response from the study platform.
Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 110 studies on the registry; 58 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Aged 18 years or older on the date of signing the form, with no upper age limit; cirrhosis confirmed by a hepatologist based on clinical findings, laboratory tests, imaging and/or endoscopy, and histopathology when necessary.
The index hospitalization is related to decompensated cirrhosis or associated complications, with evidence of decompensation such as ascites, overt hepatic encephalopathy, or variceal bleeding, or hospitalization for infection, worsening renal function, or other related complications in a patient with previous decompensation; the patient currently meets the criteria for discharge.
Plans to return home or to an out-of-hospital setting that supports follow-up, with randomization completed on the day of discharge before initiation of the intervention and the 90-day observation period beginning at discharge.
Is alert and has the capacity to understand the study and independently provide informed consent; the participant or an authorized reliable caregiver can complete mobile reporting or telephone-assisted data entry as permitted by the study.
Voluntarily provides written informed consent and separate consent for necessary data processing, and agrees to 90-day outcome ascertainment conducted at the same frequency in both study groups.
Exclusion Criteria:
Persistent severe impairment of consciousness or cognition that prevents the participant from independently providing .
Receiving end-of-life care, or participation is considered to impose a clearly disproportionate burden by the treating clinical team.
No feasible means of contact, or inability to obtain the assistance necessary for study participation.
Concurrent participation in another interventional study that clearly conflicts with this study.
Near-term hospitalizations are primarily driven by tumor progression or planned oncological treatment, such that cirrhosis-related outcomes cannot be reliably distinguished from tumor-related care.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive standard care plus 90 days of AI agent-assisted proactive management after discharge. Participants or authorized caregivers will submit brief daily health reports and may report symptoms as they occur. The service combines AI-supported information structuring, rules-based risk alerts, nurse verification, physician-led clinical decisions, and documentation of actions and follow-up.
Other: AI Agent-Assisted Proactive Management · Other: Standard Care
Participants will receive standard care without access to the study AI agent-assisted proactive management service. Existing outpatient care, telephone follow-up, clinical contact channels, and access to emergency care will be maintained. Scheduled study outcome ascertainment and safety follow-up will be performed at the same frequency as in the experimental group.
Other: Standard Care
A 90-day postdischarge management service involving daily symptom and health-status reporting, AI-supported information structuring and task coordination, rules-based risk alerts, nurse verification, physician-led clinical decisions, and documented follow-up of actions. The service covers volume status and renal function-related symptoms, infection, hepatic encephalopathy, gastrointestinal bleeding, medication adherence, and follow-up visits or referrals. Each routine daily report is expected to take approximately 3-5 minutes. The system does not autonomously diagnose, prescribe, or change medication. Critical symptoms prompt immediate emergency care without waiting for platform review.
Usual care for decompensated cirrhosis, including etiology-specific treatment, discharge instructions, written education on warning symptoms, routine follow-up arrangements, existing outpatient or telephone follow-up at each center, usual clinical contact channels, and emergency care. Existing healthcare services will be maintained in both study groups.
Proportion of Participants With a First Liver-Related Unplanned Acute Healthcare Utilization Event Within 90 Days
Proportion of participants with at least one unplanned emergency department visit, hospital observation stay, acute day-case treatment, or readmission due to acute deterioration of liver disease within 90 days after index-hospital discharge. Contacts arising from the same episode of deterioration count as one composite event. Planned care without acute deterioration and routine consultations do not qualify. Events will be verified from hospital records, authorized external records, and identical follow-up schedules in both groups. Two independent adjudicators blinded to group assignment will review events; a third will resolve disagreements. Death and liver transplantation before a qualifying event will be recorded as competing events. Uncertain event status will not be classified as no event.
Time frame: From discharge following the index hospitalization (Day 0) through Day 90.
Proportion of Participants With Liver-Related Unplanned Readmission Within 90 Days
Proportion of randomized participants with at least one unplanned inpatient readmission due to acute deterioration of liver disease within 90 days after index-hospital discharge. Readmissions will be verified using local hospital records, authorized external records, and identical follow-up procedures in both groups, with blinded endpoint adjudication. Planned admissions without acute deterioration are excluded. Hospitalizations after liver transplantation are not counted as liver-related target events under this protocol.
Time frame: From discharge following the index hospitalization (Day 0) through Day 90.
Proportion of Participants With a First Liver-Related Unplanned Acute Healthcare Utilization Event Within 30 Days
Proportion of participants with at least one unplanned emergency department visit, hospital observation stay, acute day-case treatment, or readmission due to acute deterioration of liver disease within 30 days after index-hospital discharge. Contacts arising from the same episode of deterioration count as one composite event. Planned care without acute deterioration and routine consultations do not qualify. Events will be verified from hospital records, authorized external records, and identical follow-up schedules in both groups. Two independent adjudicators blinded to group assignment will review events; a third will resolve disagreements. Death and liver transplantation before a qualifying event will be recorded as competing events. Uncertain event status will not be classified as no event.
Time frame: From discharge following the index hospitalization (Day 0) through Day 30.
Proportion of Participants With a Liver-Related Unplanned Emergency Department Visit Within 90 Days
Proportion of randomized participants with at least one unplanned emergency department visit attributable to acute deterioration of liver disease. Emergency department records, authorized external records, and follow-up information will be reviewed using the blinded adjudication procedures for the emergency department component of the primary composite outcome. Routine consultations and planned care without acute deterioration do not qualify. Events after liver transplantation are not counted as liver-related target events.
Time frame: From discharge following the index hospitalization (Day 0) through Day 90.
Proportion of Participants With Liver-Related Unplanned Hospital Observation Within 90 Days
Proportion of randomized participants with at least one qualifying unplanned hospital observation stay attributable to acute deterioration of liver disease. Observation records and related clinical documentation will be reviewed to confirm occurrence, clinical indication, and date, followed by blinded endpoint adjudication. Planned observation without acute deterioration does not qualify. Events after liver transplantation are not counted as liver-related target events.
Time frame: From discharge following the index hospitalization (Day 0) through Day 90.
Proportion of Participants Receiving Liver-Related Unplanned Acute Day-Case Treatment Within 90 Days
Proportion of randomized participants receiving at least one episode of unplanned acute day-case treatment required for acute deterioration of liver disease. A documented acute medical indication and treatment record are required, with blinded endpoint adjudication. Routine consultations and scheduled day-case treatment without acute deterioration do not qualify. Events after liver transplantation are not counted as liver-related target events.
Time frame: From discharge following the index hospitalization (Day 0) through Day 90.
Time to First Liver-Related Unplanned Acute Healthcare Utilization Event
Time in days from actual discharge to the first unplanned emergency department visit, hospital observation stay, acute day-case treatment, or readmission due to acute deterioration of liver disease, as confirmed by blinded adjudication. Contacts arising from the same episode of deterioration count as one event. Planned care without acute deterioration and routine consultations do not qualify. Death and liver transplantation before a qualifying event are competing events. Participants without a target or competing event are followed through Day 90; participants lost to follow-up are censored at the last time their outcome status was confirmed.
Time frame: From discharge following the index hospitalization (Day 0) through Day 90.
Proportion of Participants Who Die From Any Cause Within 90 Days
Proportion of randomized participants who die from any cause during the 90-day postdischarge observation period. Vital status and date of death will be verified using medical records, available death documentation, and authorized follow-up information. Deaths after liver transplantation remain included in this all-cause outcome.
Time frame: From discharge following the index hospitalization (Day 0) through Day 90.
Proportion of Participants Undergoing Liver Transplantation Within 90 Days
Proportion of randomized participants who undergo liver transplantation during the 90-day postdischarge observation period. Transplantation and its date will be verified from operative or hospitalization records, including authorized records from other hospitals.
Time frame: From discharge following the index hospitalization (Day 0) through Day 90.
Days Alive and Out of Hospital During the 90 Days After Discharge
Number of days alive and out of hospital during the 90-day postdischarge observation period, calculated as 90 minus inpatient days and days after death within that period. Overlapping days are deducted only once. All-cause inpatient days are counted, including hospitalization for liver transplantation. Days alive and out of hospital after transplantation can contribute to this outcome. Emergency department visits and day-case treatment without inpatient admission are not deducted as inpatient days. The possible range is 0 to 90 days; higher values indicate more days alive and out of hospital.
Time frame: From discharge following the index hospitalization (Day 0) through Day 90.
Proportion of Participants With Adverse Events Within 90 Days
Proportion of randomized participants with at least one adverse event of any cause during follow-up. Events will be collected in both randomized groups through study contacts, medical records, and safety reports. Seriousness, expectedness, and relatedness to the study system will be assessed separately. Participants remain in the safety summary regardless of whether they used the study system.
Time frame: From discharge following the index hospitalization (Day 0) through Day 90.
Proportion of Participants With Serious Adverse Events Within 90 Days
Proportion of randomized participants with at least one serious adverse event of any cause during follow-up. Events will be verified through study contacts, medical records, and safety reports using the protocol's seriousness criteria. Liver disease deterioration meeting serious adverse event criteria will be recorded even if it also qualifies as a clinical outcome event. Planned hospitalization for routine treatment is not automatically classified as a serious adverse event. Relatedness to the study system will be assessed separately.
Time frame: From discharge following the index hospitalization (Day 0) through Day 90.
Valid Daily Reporting Rate
For participants assigned to proactive management, the percentage of scheduled eligible home-reporting days on which a report containing all required fields is completed. The numerator is the number of valid reporting days and the denominator is the number of scheduled eligible home-reporting days. Hospitalization days, days after death or liver transplantation, formally suspended reporting days, and days after withdrawal are excluded from the denominator. Reporting status will be determined from the reporting records. Actual use and retention among all randomized participants will be described separately.
Time frame: Throughout the 90-day postdischarge intervention period.
Proportion of Participants With Complete 90-Day Outcome Ascertainment
Proportion of all randomized participants for whom the primary clinical outcome status during the 90-day postdischarge observation period and survival and liver transplantation status can be established. A confirmed death or liver transplantation is not classified as loss to follow-up. Target event status before death or transplantation must also be established; knowing the competing event alone does not resolve missing preceding event information. Ascertainment will use scheduled follow-up contacts and available local and authorized external records. Attendance at a follow-up visit alone does not establish complete outcome ascertainment.
Time frame: Assessed at completion of follow-up for the 90-day period after index-hospital discharge.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Feb 2028, 14 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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