Intervention for Alcohol Use Disorder Recovery After Liver Transplantation

Официальное название

Development and Testing of an Integrated Care Coordination Intervention for Alcohol Use Disorder Recovery After Liver Transplantation

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Online Sober Active Community
  Participants will have access to an online sober active community that they can use to augment their recovery process.
• Поведенческое Recovery coach
  Participants will work with a recovery coach including having weekly phone calls with that recovery coach.

Первичные конечные точки

• Acceptability of ILTARP (The perception that ILTARP is palatable, agreeable, or satisfactory) [Срок оценки: 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) [Срок оценки: Baseline, month 3, month 6, month 9, and study end (1 year)]
• Appropriateness of ILTARP (ILTARP suitability and relevance) [Срок оценки: Baseline, month 3, month 6, month 9, and study end (1 year)]

Вторичные конечные точки (6)

• Alcohol use clinically based on lab [Срок оценки: Baseline, month 3, month 6, month 9, and study end (1 year)]
• Alcohol use based on self report [Срок оценки: Baseline, month 3, month 6, month 9, and study end (1 year)]
• Alcohol cravings based on self report [Срок оценки: Baseline, month 3, month 6, month 9, and study end (1 year)]
• engagement in recovery resources [Срок оценки: 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 [Срок оценки: Baseline, month 3, month 6, month 9, and study end (1 year)]
• medication adherence [Срок оценки: Baseline, month 3, month 6, month 9, and study end (1 year)]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Vanderbilt University Medical Center — Nashville

Идентификаторы

NCT: NCT07214259 · 251447 · K23AA031068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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