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NCT05794555 · ClinicalTrials.gov registry record · Phase 3
LiveSMART Trial to Prevent Falls in Patients With Cirrhosis
A Phase 3 study of Cirrhosis, Liver and Portal Hypertension, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 3
- Development phase
- 230
- Enrollment target
- 3
- Study locations
NCT05794555: Completed Phase 3 study of Cirrhosis, Liver and Portal Hypertension, sponsored by University of Michigan.
NCT05794555 is a Phase 3 study of Cirrhosis, Liver and Portal Hypertension that has completed, run by University of Michigan. The registered enrollment target is 230 participants, roughly in line with the 235-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target. The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05794555, a Phase 3 study of Cirrhosis, Liver and Portal Hypertension, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 230 participants
- Enrollment target
- 3
- Study locations
Study Summary
This multicenter trial is being conducted to determine if sequential lactulose and Tele (virtual) Tai-Chi reduces the rate of injurious fall, non-injurious falls, incident overt Hepatic Encephalopathy (HE), and death or liver transplant over 24 weeks. Participants that are enrolled will be randomized to stage one of this project for approximately 12 weeks. After completing stage one, participants will be re-randomized to stage 2 of the project that will last approximately 12 more weeks. The study hypothesizes that sequential lactulose/TeleTai-Chi will reduce falls, incident overt HE, death and physical frailty and will improve cognitive function, and Health Related Quality of Life (HRQOL) over 24 weeks compared to other treatment combinations. As detailed below, an observational component that enrolls caregivers of the trial participants is being conducted. Upon completion, Participants listed in the record here only include trial participants; and the observational component was moved to a new registration for clarity, NCT07140120.
Primary Outcome
Composite outcome is defined as any of the following: • Injurious Fall: Fracture, dislocation, cut, head injury, soft - tissue injury requiring medical intervention including: Hospitalization or overnight observation in the Emergency Room (ER); surgery, transfusion, stitches * Non - Injurious Fall: Inadvertently coming to rest on the floor or lower level * Include falls that result in minor injuries that are addressed with first aid (e.g., ice, bandage) * Incident Overt HE: Acute disorienta
Conditions Studied
Interventions
- BEHAVIORAL Enhanced Usual Care
- DRUG Lactulose
- BEHAVIORAL Investigator recommended exercise
- BEHAVIORAL TeleTai-Chi (virtual)
Study Locations (3)
Michigan
- University of Michigan - Ann Arbor
Pennsylvania
- University of Pennsylvania - Philadelphia
Texas
- Baylor Scott & White Research Institute (BSW) - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2023-06-13 |
| Est. Completion | 2025-03-07 |
| Phase | Phase 3 |
What the finished NCT05794555 record still lists
NCT05794555 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 235-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target.
The record links to 2 conditions, with Cirrhosis, Liver appearing as the primary indexed condition, and to 4 interventions - of which Enhanced Usual Care is the first listed.
NCT05794555 reports a single indexed study location in Michigan, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT05794555 about?
NCT05794555 is a clinical study titled "LiveSMART Trial to Prevent Falls in Patients With Cirrhosis". This multicenter trial is being conducted to determine if sequential lactulose and Tele (virtual) Tai-Chi reduces the rate of injurious fall, non-injurious falls, incident overt Hepatic Encephalopathy (HE), and death or liver transplant over 24 weeks. Participants that are enrolled will be randomiz...
What is the current status of trial NCT05794555?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 230 participants. The study started on 2023-06-13. Estimated completion is 2025-03-07.
What conditions does trial NCT05794555 study?
This clinical trial studies the following conditions: Cirrhosis, Liver, Portal Hypertension.
What interventions are being tested in trial NCT05794555?
The interventions under investigation include: Enhanced Usual Care (BEHAVIORAL), Lactulose (DRUG), Investigator recommended exercise (BEHAVIORAL), TeleTai-Chi (virtual) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05794555?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05794555 being conducted?
This trial has 3 study locations across Michigan, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cirrhosis, Liver
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05794555's enrollment target sits among peer trials
230 11th of 34 higher than 24 of 34 other Cirrhosis, Liver trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis, Liver trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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