LiveSMART Trial to Prevent Falls in Patients With Cirrhosis

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The Clinicaltrials.gov registration record was updated as requested by Patient-Centered Outcomes Research Institute (PCORI) based on protocol amendment version 3.0 after approval by the Institutional Review Board. These changes included: the additional aim for a supplemental observational study to assess social determinants of health, financial burdens, etc., and includes recruitment of the caregivers for this supplemental study along with the trial participants, as well as updated outcomes for the trial. The caregivers that are enrolled are not in the clinical trial. Because all of the outcome measures in the supplemental study are other outcome measures (neither primary nor secondary to the trial) these are not included in this registration. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05794555
Study type	Interventional
Source	University of Michigan
Contact	Samantha Nikirk
Phone	734-232-4182
Email	samjwalk@med.umich.edu
Status	Recruiting
Phase	Phase 3
Start date	June 13, 2023
Completion date	September 2025

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