Intervention for Alcohol Use Disorder Recovery After Liver Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Online Sober Active Community, Recovery coach.
- Who it may be relevant to
- Registry conditions: Liver Transplant Recipient, Alcohol Use Disorders (AUD). Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Testing of an Integrated Care Coordination Intervention for Alcohol Use Disorder Recovery After Liver Transplantation
Overview
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
Detailed 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.
Interventions
- Behavioral Online Sober Active Community
Participants will have access to an online sober active community that they can use to augment their recovery process. - Behavioral Recovery coach
Participants will work with a recovery coach including having weekly phone calls with that recovery coach.
Primary outcome measures
- Acceptability of ILTARP (The perception that ILTARP is palatable, agreeable, or satisfactory) [Time frame: Baseline, month 3, month 6, month 9, and study end (1 year)]
- Feasibility of ILTARP (the degree to which ILTARP can be carried out successfully) [Time frame: Baseline, month 3, month 6, month 9, and study end (1 year)]
- Appropriateness of ILTARP (ILTARP suitability and relevance) [Time frame: Baseline, month 3, month 6, month 9, and study end (1 year)]
Secondary outcome measures (6)
- Alcohol use clinically based on lab [Time frame: Baseline, month 3, month 6, month 9, and study end (1 year)]
- Alcohol use based on self report [Time frame: Baseline, month 3, month 6, month 9, and study end (1 year)]
- Alcohol cravings based on self report [Time frame: Baseline, month 3, month 6, month 9, and study end (1 year)]
- engagement in recovery resources [Time frame: Baseline, month 3, month 6, month 9, and study end (1 year). The participants will select what resources they have used and how often they have been used. This is not a summarized scale therefore there is not a better or worse outcome.]
- clinic and lab adherence [Time frame: Baseline, month 3, month 6, month 9, and study end (1 year)]
- medication adherence [Time frame: Baseline, month 3, month 6, month 9, and study end (1 year)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashville
Identifiers
NCT: NCT07214259 · 251447 · K23AA031068