Peer Support for Liver Transplant Recipients With History of ALD

Официальное название

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

Обзор

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?

Подробное описание

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.

Вмешательства

• Поведенческое Peer Support
  The study will recruit PSS based on lived experiences with ALD/LT and interpersonal skills. The PSS will receive tailored skills training from the study team in areas such as delivering brief counseling, active listening, and maintaining confidentiality. Participants will meet regularly with a PSS between standard clinic visits throughout a one-year study period. The PSS will deliver brief counseling interventions at each session. Study investigators will meet with the PSS at scheduled interval

Первичные конечные точки

• Alcohol Consumption [Срок оценки: Up to 1 year]

Вторичные конечные точки (2)

• Liver Transplant Medical Treatment Engagement [Срок оценки: Up to 1 year]
• Overall Post-Liver Transplant Survival [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Johns Hopkins University School of Medicine — Baltimore

Идентификаторы

NCT: NCT07397598 · IRB00466249 · P50AA027054

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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