Development and Testing of an Integrated Care Coordination Intervention for Alcohol Use Disorder Recovery After Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Acceptability of ILTARP (The perception that ILTARP is palatable, agreeable, or satisfactory)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
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.
干预措施: Recovery coach (Behavioral)
Intervention
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.
干预措施: Online Sober Active Community (Behavioral)
Intervention
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.
干预措施: Recovery coach (Behavioral)
结局指标
主要结局
Acceptability of ILTARP (The perception that ILTARP is palatable, agreeable, or satisfactory)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Alcohol use clinically based on lab(Baseline, month 3, month 6, month 9, and study end (1 year))
- Alcohol use based on self report(Baseline, month 3, month 6, month 9, and study end (1 year))
- Alcohol cravings based on self report(Baseline, month 3, month 6, month 9, and study end (1 year))
- Alcohol use clinically based on lab(Baseline, month 3, month 6, month 9, and study end (1 year))
- 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.)
- Alcohol use based on self report(Baseline, month 3, month 6, month 9, and study end (1 year))
- Alcohol cravings based on self report(Baseline, month 3, month 6, month 9, and study end (1 year))
- clinic and lab adherence(Baseline, month 3, month 6, month 9, and study end (1 year))
- medication adherence(Baseline, month 3, month 6, month 9, and study end (1 year))
研究者
Leigh Anne Dageforde
Associate Professor of Surgery
Vanderbilt University Medical Center