Artificial Intelligence-Assisted Care After Hospital Discharge for People With Decompensated Cirrhosis
NCT07931404, Not applicable, Not yet recruiting, Beijing Tsinghua Chang Gung Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Artificial Intelligence-Assisted Care After Hospital Discharge for People With Decompensated Cirrhosis | ClinicalTrials.gov |
| NCT number | NCT07931404 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 180 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beijing Tsinghua Chang Gung Hospital | ClinicalTrials.gov |
| Conditions | Decompensated Liver Cirrhosis | ClinicalTrials.gov |
| Interventions | AI Agent-Assisted Proactive Management, Standard Care | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of Participants With a First Liver-Related Unplanned Acute Healthcare Utilization Event Within 90 Days | From discharge following the index hospitalization (Day 0) through Day 90. | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants With Liver-Related Unplanned Readmission Within 90 Days | From discharge following the index hospitalization (Day 0) through Day 90. | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants With a First Liver-Related Unplanned Acute Healthcare Utilization Event Within 30 Days | From discharge following the index hospitalization (Day 0) through Day 30. | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants With a Liver-Related Unplanned Emergency Department Visit Within 90 Days | From discharge following the index hospitalization (Day 0) through Day 90. | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants With Liver-Related Unplanned Hospital Observation Within 90 Days | From discharge following the index hospitalization (Day 0) through Day 90. | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants Receiving Liver-Related Unplanned Acute Day-Case Treatment Within 90 Days | From discharge following the index hospitalization (Day 0) through Day 90. | 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. | ClinicalTrials.gov |
| Secondary | Time to First Liver-Related Unplanned Acute Healthcare Utilization Event | From discharge following the index hospitalization (Day 0) through Day 90. | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants Who Die From Any Cause Within 90 Days | From discharge following the index hospitalization (Day 0) through Day 90. | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants Undergoing Liver Transplantation Within 90 Days | From discharge following the index hospitalization (Day 0) through Day 90. | 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. | ClinicalTrials.gov |
| Secondary | Days Alive and Out of Hospital During the 90 Days After Discharge | From discharge following the index hospitalization (Day 0) through Day 90. | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants With Adverse Events Within 90 Days | From discharge following the index hospitalization (Day 0) through Day 90. | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants With Serious Adverse Events Within 90 Days | From discharge following the index hospitalization (Day 0) through Day 90. | 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. | ClinicalTrials.gov |
| Other | Valid Daily Reporting Rate | Throughout the 90-day postdischarge intervention period. | 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. | ClinicalTrials.gov |
| Other | Proportion of Participants With Complete 90-Day Outcome Ascertainment | Assessed at completion of follow-up for the 90-day period after index-hospital discharge. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)