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临床试验/NCT07397598
NCT07397598尚未招募不适用

Peer Support to Enhance Care for Liver Transplant Recipients Who Had Alcohol-Associated Liver Disease

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2026年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
95
试验地点
1
主要终点
Alcohol Consumption

研究概览

简要总结

Liver transplant (LT) recipients with a history of alcohol-related liver disease (ALD) may encounter various psychosocial and medical challenges during post-LT recovery, even beyond the initial post-transplant period. Effective and sustainable interventions will be crucial for improving patient outcomes. This clinical trial will examine the impact of peer support specialists (PSS) on the recovery experience of individuals who received LT for ALD. The trial seeks to answer two main questions:

  • Are LT recipients who work with PSS less likely to resume alcohol use or tend to drink less overall?
  • Do LT recipients who work with PSS engage more with recommended medical care and have better overall survival?

详细描述

In the United States, ALD is the most common indication for LT. Resuming alcohol use is a major concern for all LT recipients with a history of ALD, with estimates ranging from 16% to 49% and increasing with more time since LT. Although most LT programs have required pre-LT alcohol treatment, post-LT services have been far more heterogeneous, despite the potentially severe consequences of alcohol relapse during this period. The present study proposes implementing and evaluating a care model for LT recipients with a history of ALD after the first post-LT year. The investigators will conduct a single-arm clinical trial to integrate PSS into routine medical care starting in years 2 through 4 following LT. The study will recruit PSS based on lived experiences with ALD/LT and interpersonal skills. The PSS will first receive tailored skills training from the study team in areas such as delivering brief counseling, active listening, and maintaining confidentiality. The PSS will then meet with study participants at regular intervals between standard clinic visits. The investigators will follow participants working with PSS for 1 year and compare the participants with a historical control group of transplant recipients without PSS to determine whether the intervention improves outcomes. Key endpoints will include alcohol use (by self-report and biomarker), retention in post-transplant medical care, and overall survival.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English speakers
  • Received a liver transplant for alcohol-associated liver disease
  • Has 1 to 3 years of continuous alcohol abstinence at the time of trial entry

排除标准

  • Liver transplant recipients without a history of alcohol-associated liver disease
  • Inability to provide informed consent
  • Active participation in a separate intervention trial for alcohol use disorder

研究组 & 干预措施

Peer Support Specialist (PSS)

Experimental

干预措施: Peer Support (Behavioral)

结局指标

主要结局

Alcohol Consumption

时间窗: Up to 1 year

Any use or excessive use (i.e., \>7/\>14 drinks per week for women/men) by biomarker or self-report

次要结局

  • Liver Transplant Medical Treatment Engagement(Up to 1 year)
  • Overall Post-Liver Transplant Survival(Up to 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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