Self-Management Programs for Pain in Liver Cirrhosis
(ALLEVIATE-C Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how two different self-management programs can reduce pain and improve quality of life in adults with liver cirrhosis. Participants will be randomly assigned to either a low-touch or high-touch self-management program, both offering drug-free pain management methods. The low-touch group will use a digital program with educational content and receive a Fitbit. The high-touch group will also receive personalized coaching and participate in activities like walking or meditation. Individuals with liver cirrhosis who experience chronic pain and have regular access to a smartphone might be well-suited for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative, drug-free pain management strategies.
What prior data suggests that these self-management programs are safe for managing pain in liver cirrhosis?
A previous study found a personalized pain self-management program for people with cirrhosis to be practical and well-received. Of the 21 participants, 76% attended most sessions, and the program met all standards for acceptability, meaning participants found it reasonable and helpful. This indicates that the hands-on self-management program is safe and well-tolerated.
No specific safety information is available for the less intensive self-management program. However, since this clinical trial focuses on self-management techniques without drugs, the risks are likely lower than those of medication-based treatments. Both programs aim to help manage pain, suggesting they could be a safe option for those interested in non-drug pain management strategies.12345Why are researchers excited about this trial?
Researchers are excited about these self-management programs for pain in liver cirrhosis because they offer innovative, patient-centered approaches to managing symptoms. Unlike standard treatments that often rely on medications or more generalized support groups, the high-touch program provides individualized pain coaching and allows participants to choose a primary focus like walking or meditation, which can be more engaging and personalized. The low-touch program also stands out by using a digital platform to deliver automated educational content and behavioral nudges, making pain management more accessible and convenient for participants. These programs could empower patients to take control of their pain management in a more tailored and effective way.
What evidence suggests that this trial's self-management programs could be effective for pain in liver cirrhosis?
Research has shown that self-management programs can help people with liver cirrhosis manage pain and improve their quality of life. Studies have found that non-drug methods, like those in self-management programs, help patients handle stress better and boost their mood. In this trial, participants in the high-touch program will receive personalized support and coaching, which greatly increased patients' understanding of how to manage pain without medication in previous studies. Meanwhile, participants in the low-touch program will use digital tools and text reminders, which have also boosted people's confidence in managing their own health. Both types of programs have shown promise in reducing pain and improving the quality of life for those with chronic pain from cirrhosis.678910
Are You a Good Fit for This Trial?
This trial is for adults with liver cirrhosis who also have ongoing pain. Participants should be able to use digital tools and follow a self-management program. People with other serious health issues or those unable to participate in the activities may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants undergo a 4-week run-in period before the main intervention
Intervention
Participants receive either a low-touch or high-touch self-management program for pain management
Follow-up
Participants are monitored for safety and effectiveness after the intervention
What Are the Treatments Tested in This Trial?
Interventions
- High-touch self-management program
- Low-touch self-management program
Trial Overview
The study compares two drug-free pain management programs: one offers basic digital support (low-touch), while the other provides more personalized coaching and group sessions (high-touch). Both groups learn new ways to manage pain, and all participants get a Fitbit.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants receive access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.
Participants 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
University of Michigan
Collaborator
University of Miami
Collaborator
Johns Hopkins University
Collaborator
Mayo Clinic
Collaborator
Columbia University
Collaborator
University of California, San Francisco
Collaborator
Vanderbilt University Medical Center
Collaborator
Citations
Improving Pain Management and Opioid Safety for Patients ...
Prescription opioid medications are a leading cause of opioid-related death and are particularly risky in patients with liver cirrhosis.
2.
mdedge.com
mdedge.com/internalmedicine/article/255747/hepatology/are-pain-meds-only-option-chronic-pain-cirrhosisAre pain meds the only option for chronic pain in cirrhosis?
An estimated 40%-79% of cirrhosis patients experience chronic pain, and it can be a key factor in worsening functional status and quality of ...
Follow Keyword
This study aimed to systematically evaluate the quality of self-care mobile applications for fatty liver patients based on the MARS rating features. BMC ...
Project Details
PROJECT SUMMARY Even though 45-85% of older adults (age ≥65 years) suffer from chronic pain, little evidence exists for how to treat their chronic pain ...
Assessing a peer-led pain and wellness self-management ...
Participants showed statistically significant increases in knowledge around medications and sources of information about pain management, ...
A tailored pain self-management intervention for patients with ...
The purpose of this pilot study was to evaluate the feasibility and acceptability of a tailored pain self-management (PSM) intervention for people with ...
7.
dom.pitt.edu
dom.pitt.edu/a-tailored-pain-self-management-intervention-for-patients-with-cirrhosis-is-acceptable-and-improves-pain-control/A tailored pain self-management intervention for patients ...
RESULTS: Among 21 participants who started the intervention, 16 (76%) attended ≥80% of sessions. Acceptability thresholds were met at all time ...
Managing cirrhosis pain without drugs
Over 12 months, ALLEVIATE-C will compare patients randomized to two arms featuring either a high-touch or low-touch self-management program.
Study Details | NCT07792850 | The Application of Lifestyle ...
The study will compare effectiveness of a high-touch vs low-touch self-management program to treat chronic pain among patients with cirrhosis.
10.
facebook.com
facebook.com/varesearch/posts/varesearchnewsbrief-new-coaching-method-improves-cirrhosis-associated-chronic-pa/1456955103140378/New coaching method improves cirrhosis-associated ...
A tailored self-management intervention for pain can improve quality of life for those with cirrhosis. Participants with cirrhosis and chronic ...
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