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 through Active Choice as the primary behavioral focus for 48 weeks. The high-touch arm also includes on-demand coaching for low-pain self-efficacy and optional group coaching sessions. Participants in the low-touch arm receive access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks. Remote or in-person follow up study visits will occur at 12, 24, 36, and 48 weeks. Endpoints include: * Primary: Change from baseline in pain interference over 48 weeks (measured using the Pain, Enjoyment of Life, and General Activity (PEG) scale). * Secondary: Health-related quality of life, cognitive function, average daily step count, pain-related disability, nociplastic pain, cumulative exposure to potentially risky medications, days alive and out of the hospital, pain management strategies, intervention engagement, and care partner burden. * Implementation: Acceptability, feasibility, intervention fidelity, and barriers and facilitators to implementation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
625
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.
University of California San Francisco
San Francisco, California, United States
University of Miami
Miami, Florida, United States
John Hopkins University
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Columbia University
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
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.
Time frame: 48 weeks
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.
Time frame: 48 weeks
Average daily step count
Change from baseline in average daily step count over 48 weeks, captured via wearable fitness trackers (Fitbit).
Time frame: 48 weeks
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.
Time frame: 48 weeks
Severity of nociplastic pain
Change from baseline in severity of nociplastic pain over 52 weeks, assessed using the Fibromyalgia Severity Score (FSS).
Time frame: 52 weeks
Cumulative exposure to potentially risky medications
Change from baseline in cumulative exposure to potentially risky medications over 48 weeks, quantified using the Opioid Total Standardized Dose (TSD) across medication classes relevant to cirrhosis.
Time frame: 48 weeks
Days alive and out of the hospital
Days alive and out of the hospital (DAOH) over 48 weeks, incorporating hospitalizations, emergency room (ER) visits, and death.
Time frame: 48 weeks
Animal Naming Test
Change in cognitive function, measured by the Animal Naming Test (ANT), over 48 weeks.
Time frame: 48 weeks
Patient-reported use and perceived effectiveness of pharmacologic and non-pharmacologic pain management strategies
Change from baseline in patient-reported use and perceived effectiveness of pharmacologic and non-pharmacologic pain management strategies at 52 weeks, assessed using a structured study-specific pain management inventory.
Time frame: 52 weeks
Caregiver burden
Change from baseline in care partner caregiver burden, measured by the 12-item Zarit Burden Interview (ZBI-12), over 48 weeks.
Time frame: 48 weeks
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