Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
Location contact
Mary E. McCaul, PhD
CONTACT
Po-Hung Chen, MD, PhD
CONTACT
NCT Number: NCT07397598
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?
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21287, United States
Mary E. McCaul, PhD
CONTACT
Po-Hung Chen, MD, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 intervals to review progress. Study investigators will also review up to 20% of the audio recordings of sessions between PSS and study participants to assess fidelity to the intervention protocol.
Time frame: Up to 1 year
Any use or excessive use (i.e., >7/>14 drinks per week for women/men) by biomarker or self-report
Time frame: Up to 1 year
Proportion of kept/scheduled LT follow-up medical appointments
Time frame: Up to 1 year
All-cause mortality
Contact information is provided by the study sponsor or research team.
Mary E. McCaul, PhD
CONTACT
Po-Hung Chen, MD, PhD
CONTACT
Johns Hopkins University
Other
Peer Support to Enhance Care for Liver Transplant Recipients Who Had Alcohol-Associated Liver Disease
Acronym: THRIVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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