The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis

Summary

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

Conditions

• Cirrhoses, Liver

Interventions

BEHAVIORAL

High-touch self-management program

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.

BEHAVIORAL

Low-touch self-management program

Access to the self-guided digital self-management platform with automated educational content and behavioral nudges for 48 weeks.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Miami

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Columbia University

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Vanderbilt University Medical Center

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of Pennsylvania

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-01-01

Primary Completion

2030-03-01

Completion

2030-06-01

Countries

• United States

Study Locations