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

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

Ngôn ngữ: eng

Ký hiệu phân loại: 627.12 Rivers and streams

Thông tin xuất bản: United States : Hepatology communications , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 214288

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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