Intervention for Alcohol Use Disorder Recovery After Liver Transplantation (ILTARP)

Leigh Anne Dageforde

Status: Begins enrollment in 4 months

Conditions: Alcohol Use Disorders (AUD); Liver Transplant Recipient

Treatments: Behavioral: Online Sober Active Community; Behavioral: Recovery coach

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07214259

251447

K23AA031068 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this clinical trial is to learn if it is feasible and acceptable to use a recovery coach and an online sober active community to help with alcohol use disorder after liver transplant. The main questions it aims to answer are:

• Is using a recovery coach after liver transplant to help with alcohol use recovery feasible and acceptable?
• Is using an online sober active community after liver transplant to help with alcohol use recovery feasible and acceptable? Researchers will compare standard of care including a recovery coach alone to a recovery coach plus to assist with recovery from alcohol use recovery after liver transplant

Participants will:

• Work with a recovery coach including a weekly phone call
• Visit the clinic once every 3 months for a checkup and to complete surveys
• If randomized to the intervention arm, download an online application with access to a digital sober active community

Full description

Rates of alcohol use disorder and alcohol associated liver disease requiring liver transplantation continue to rapidly rise. Return to alcohol use after liver transplant is associated with increased rates of liver transplant failure and mortality, but there is no evidence-based integrated intervention to address alcohol use disorder in liver transplant recipients. The goal of this pilot feasibility randomized control trial is to address a critical gap in knowledge and care for liver transplant recipients with concurrent alcohol use disorder by developing and pilot testing an integrated liver transplant and alcohol recovery program (ILTARP) consisting of a recovery coach supporting post-transplant alcohol relapse prevention, outreach, and care coordination with the added intervention of access to an active sober community. The investigators will conduct a pilot feasibility study of the newly developed ILTARP intervention testing feasibility, acceptability, and potential effectiveness of ILTARP in the liver transplant clinical setting.

Enrollment: 40 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Enrollment:

• Age greater than or equal to 21 years old
• Recipient of liver transplant less than or equal to 5 years ago
• History of alcohol use disorder
• Able to understand the purpose of the study and willing to participate and sign informed consent
• Has a smart phone to use for contact with recovery coach and the digital sober active community without additional personal cost
• Willing to participate in online digital community

Exclusion Criteria for Enrollment

• Liver transplant recipient for reason other than alcohol associated liver disease
• Liver transplant greater than 5 years ago
• No mechanism for regular phone contact
• No ability to utilize an application for a digital sober active community
• Any condition that in the opinion of the PI introduces undue risk by participating in this study
• less than 21 years of age
• no history of alcohol use disorder
• Any condition that in the opinion of the PI introduces undue risk by participating in this study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control

Active Comparator group

Description:

The participants in the control arm will work with a recovery coach and have weekly phone calls with the recovery coach. They will visit the clinic every 3 months for an in-person visit and to complete survey measures related to the study.

Treatment:

Behavioral: Recovery coach

Intervention

Experimental group

Description:

The participants in the intervention arm will work with a recovery coach and have weekly phone calls with the recovery coach. They will also have access to an online sober active community that they can use to augment their recovery process. They will visit the clinic every 3 months for an in-person visit and to complete survey measures related to the study.

Treatment:

Behavioral: Recovery coach

Behavioral: Online Sober Active Community