Alcohol Use Disorders (AUD), Liver Transplant Recipient
Conditions
Keywords
liver transplant, alcohol use disorder, alcohol associated liver disease, recovery coach, sober active community
Brief summary
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
BEHAVIORALOnline Sober Active Community
Participants will have access to an online sober active community that they can use to augment their recovery process.
BEHAVIORALRecovery coach
Participants will work with a recovery coach including having weekly phone calls with that recovery coach.
Sponsors
Leigh Anne Dageforde
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of ILTARP (The perception that ILTARP is palatable, agreeable, or satisfactory) | Baseline, month 3, month 6, month 9, and study end (1 year) | Measured by the Acceptability of Intervention Measure (AIM) survey. The scale ranges from 3 to 15 with a high score indicating greater acceptability. |
| Feasibility of ILTARP (the degree to which ILTARP can be carried out successfully) | Baseline, month 3, month 6, month 9, and study end (1 year) | Measured by the Feasibility of Intervention Measure (FIM) survey. The scale ranges from 3 to 15 with a high score indicating greater feasibility. |
| Appropriateness of ILTARP (ILTARP suitability and relevance) | Baseline, month 3, month 6, month 9, and study end (1 year) | Measured by the Intervention Appropriateness Measure (IAM).The scale ranges from 3 to 15 with a high score indicating greater appropriateness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol use clinically based on lab | Baseline, month 3, month 6, month 9, and study end (1 year) | the lab test phosphatidylethanol will be used to assess alcohol use |
| Alcohol use based on self report | Baseline, month 3, month 6, month 9, and study end (1 year) | Alcohol use will be self reported using the Alcohol Use Disorders Identification (AUDIT-C) scale. The scale ranges from 0 to 12 with 0 being the lowest amount of alcohol and 12 being the most amount of alcohol. |
| Alcohol cravings based on self report | Baseline, month 3, month 6, month 9, and study end (1 year) | Alcohol cravings will be self reported using the Penn Alcohol Craving Scale (PACS). Scale score ranges from 0-30 with 0 being the least amount of cravings and 30 the most. |
| engagement in recovery resources | 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. | Participants will complete a survey on their engagement in recovery resources. |
| clinic and lab adherence | Baseline, month 3, month 6, month 9, and study end (1 year) | The number of missed lab appointments and transplant clinic no-show rates will be calculated from the medical record. |
| medication adherence | Baseline, month 3, month 6, month 9, and study end (1 year) | Tacrolimus levels will be obtained from the medical record to calculate tacrolimus intrapatient variability. |
Countries
United States
Contacts
CONTACTLeigh Anne Leigh Anne Dageforde, MD, MPH
Outcome results
None listed