University of Pennsylvania
The goal of this clinical trial is to test a low-touch vs high-touch drug-free pain self-management program that may help lower pain and improve quality of life for adults with cirrhosis and pain. Participants are assigned by chance to one of two study groups. The groups receive different levels of support. The main questions it aims to answer are: * Do the programs help lower pain? * Do the programs improve quality of life? * Is one program more effective than the other? Researchers will compare a low-touch self management program to a high-touch self-management program to see if the programs help manage pain. Participants in the low-touch arm will: * Learn new ways to manage pain without medication * Receive access to the self-guided digital self-management platform * Receive general behavioral text message nudges * Receive a free Fitbit to keep Participants in the high-touch arm will: * Learn new ways to manage pain without medication * Receive tailored access to the self-guided digital self-management platform * Received individualized pain coaching and optional group coaching sessions * Participate in a structured walking or meditation curriculum * Receive a free Fitbit to keep
The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis (ALLEVIATE-C) is a multicenter, individual-level, parallel-arm, 1:1 randomized superiority trial with a 4-week run-in period followed by 48 weeks of intervention and follow-up. The study will compare effectiveness of a high-touch vs low-touch self-management program to treat chronic pain among patients with cirrhosis. Participants in the high-touch arm receive tailored digital self-management program, individualized pain coaching, and a structured walking or meditation curriculum selected thr…
Patient Inclusion Criteria: 1. Age \> 18 years of age. 2. Clinical diagnosis of cirrhosis established by any one of the following: 1. Liver biopsy consistent with cirrhosis. 2. Noninvasive evidence of cirrhosis, defined as ≥2 of the following criteria: * Imaging (Ultrasound (US), Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)) demonstrating cirrhosis liver morphology (e.g., 'cirrhosis', cirrhotic appearing', 'nodular') with supportive findings (e.g., splenomegaly or recanalized umbilical vein). * Transient elastography (TE) (FibroScan) liver stiffness \> 12.5…
Tailored digital self-management program, individualized pain coaching, and a structured walking or meditation curriculum selected through Active Choice as the primary behavioral focus for 48 weeks. On-demand coaching for low-pain self-efficacy and optional group coaching sessions.
Access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.