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PubMed · 39969429

LIVE-SMART: A sequential, multiple assignment randomized trial to reduce falls in cirrhosis.

Elliot B Tapper·Samantha Nikirk·Donna M Evon·Sumeet Asrani·Patricia Bloom·James W Hynes·J Mark Alber·Anna Gill·Shivang Mehta·Ethan Weinberg·Neil B Alexander·Katie Althuis·Alise Hoelscher·Lili Zhao·Xi Chen·Alex Burdzy·Marina Serper
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Abstract

INTRODUCTION: Falls are a major threat to the well-being of patients with cirrhosis. We are performing a clinical trial to determine whether lactulose, TeleTai-Chi, or their combination will reduce falls in HE and improve health-related quality of life (HRQOL) among patients with cirrhosis. METHODS AND ANALYSIS: Patients with cirrhosis and portal hypertension without HE will be enrolled in 3 US states and followed participants for 24 weeks. In stage 1 (12 wk), participants will be randomized to receive either lactulose therapy or enhanced usual care. In stage 2 (12 wk), participants will be randomized to either TeleTai-Chi or usual care. The primary outcome is a hierarchical composite: Injurious falls, noninjurious falls, incident HE, and death/transplantation. Secondary outcomes include cognitive function, days-alive and out-of-hospital, and HRQOL. After completion of the interventions, participants will be followed for 48 weeks for health and financial outcomes. ETHICS AND DISSEMINATION: Our study has a central institutional review board with individual site IRB review. Dissemination includes the publication of study findings and patient-focused educational webinars.

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FemaleHumansMaleMiddle AgedAccidental FallsHepatic EncephalopathyHypertension, PortalLactuloseLiver CirrhosisQuality of LifeRandomized Controlled Trials as TopicClinical Trial ProtocolJournal Article

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Elliot B Tapper, Samantha Nikirk, Donna M Evon, Sumeet Asrani, Patricia Bloom, James W Hynes, J Mark Alber, Anna Gill, Shivang Mehta, Ethan Weinberg, Neil B Alexander, Katie Althuis, Alise Hoelscher, Lili Zhao, Xi Chen, Alex Burdzy, Marina Serper. 2025-02-19. LIVE-SMART: A sequential, multiple assignment randomized trial to reduce falls in cirrhosis.. https://doi.org/10.1097/hc9.0000000000000626

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