Self-Management Programs for Pain in Liver Cirrhosis

(ALLEVIATE-C Trial)

Not yet recruiting at 7 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

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

Care partner ability to speak and read English or Spanish
Ability to speak and read English or Spanish
Reliable access to Wi-Fi or cellular data
See 10 more

Exclusion Criteria

I have had more than 2 fluid drainages from my abdomen in the last 56 days.
Inpatient hospital admission lasting > 24 hours within 28 days prior to consent
My care partner is able to read and take part in study activities.
See 15 more

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

Group I: Low-TouchExperimental Treatment1 Intervention
Group II: High-TouchExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+

University of Miami

Collaborator

Trials
976
Recruited
423,000+

Johns Hopkins University

Collaborator

Trials
2,366
Recruited
15,160,000+

Mayo Clinic

Collaborator

Trials
3,427
Recruited
3,221,000+

Columbia University

Collaborator

Trials
1,529
Recruited
2,832,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

Vanderbilt University Medical Center

Collaborator

Trials
922
Recruited
939,000+