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
Age > 18 years of age.
Liver biopsy consistent with cirrhosis.
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 kilopascal (kPa) with IQR/Median <30% or Magnetic resonance elastography > 5.0 kPa
Acute pain due to injury (e.g., surgery, fracture, trauma, burn) within 28 days.
Diagnosed or suspected noncirrhotic portal hypertension.
Episode of overt hepatic encephalopathy (HE) within 28 days prior to consent.
Model for End-Stage Liver Disease - Na (MELD-Na) score > 25 calculated using the UNOS algorithm.
Parallel
High-touch self-management program
BehavioralTailored 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.
Low-touch self-management program
BehavioralAccess to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.
Pain Interference
Change from baseline in pain interference over 48 weeks, measured by repeated assessments using the Pain, Enjoyment of life, and General activity (P.E.G.) scale at 12, 24, 36, and 48 weeks, and compared between the two groups. The PEG is a three-item scale with a minimum value of 0 and a maximum value of 10 for each question. A higher score indicates a worse outcome.
Health-related quality of life
Change from baseline in health-related quality of life over 48 weeks, assessed using the PROMIS-29+2 Profile v2.1 (PROPr) domain T-scores (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference) as well as the multidomain PROPr summary score. Most domains of the PROPr are ranked on a scale with a minimum of 1 and a maximum of 5. Scores for domains are assessed differently. For fatigue, anxiety, depression, sleep disturbance, and pain interference, a higher score indicates a worse outcome. For physical function, cognitive function, and ability to participate in social roles, a higher score indicates a better outcome. Pain intensity is separately ranked on a scale of 0 to 10, with a higher score indicating a worse outcome.
Average daily step count
Change from baseline in average daily step count over 48 weeks, captured via wearable fitness trackers (Fitbit).
Pain-related disability
Change from baseline in pain-related disability at 48 weeks, measured by the Pain Disability Index (PDI) total score. The PDI is a 7-item scale with a minimum value of 0 and a maximum value of 10 for each question. A higher score indicates a worse outcome.
Severity of nociplastic pain
Change from baseline in severity of nociplastic pain over 52 weeks, assessed using the Fibromyalgia Severity Score (FSS).
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
University of Michigan
Collaborator
University of Miami
Collaborator
Johns Hopkins University
Collaborator
Columbia University
Collaborator
University of California, San Francisco
Collaborator
Vanderbilt University Medical Center
Collaborator
Mayo Clinic
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
