LiveSMART Trial to Prevent Falls in Patients With Cirrhosis (NCT05794555) | Clinical Trial Compass
CompletedPhase 3
LiveSMART Trial to Prevent Falls in Patients With Cirrhosis
United States230 participantsStarted 2023-06-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of cirrhosis based on histology and/or imaging specified in the protocol.
* Evidence of portal hypertension - must meet at least one of the following criteria:
* Ascites (present or within past 2 years)
* Varices (seen by Esophagogastroduodenoscopy or by Ultrasound(US) or cross-sectional imaging)
* Fibroscan Liver stiffness measurement (LSM) \>25 kilopascals (kPa) (if no other factors present)
* Magnetic resonance elastography (MRE) LSM \> 5 kPa (if no other factors present)
* Acoustic radiation force impulse LSM \> 17kpa (if no other factors present)
* Hepatic vein pressure gradient \> 10 millimetres of mercury (mmHg)
* Portal hypertensive gastropathy seen on Esophagogastroduodenoscopy
* Platelet count \< 80/ units per liter (uL)
* Recanalized umbilical vein (by US or cross-sectional imaging)
* Access to Wireless Fidelity (Wi-Fi) at home
* Owns or access to a smartphone, tablet or computer
* English or Spanish speaking
* Willing to participate in exercise program
Exclusion Criteria:
* Overt hepatic encephalopathy (HE) within 6 months, requiring \>28 days total of lactulose
* Took lactulose for non - HE reasons for \>28 days total in last 6 months
* Took Rifaximin for \> 28 days total in last 6 months
* Model for End Stage Liver Disease (MELD) \> 25 (Exception: MELD \> 25 with clinically stable End-Stage Renal Disease (ESRD) for whom the bilirubin is \< 5 g/dL)
* Barcelona Clinic Liver Cancer (BCLC) \> C Hepatocel…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients experiencing a hierarchical composite of events over 24 weeks: injurious falls, non-injurious falls, incident Hepatic Encephalopathy, liver transplant, and death/transplant
Timeframe: Baseline to 24 weeks (following stage 2)