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Peer Support for Liver Transplant Recipients With History of ALD

ConditionsAlcohol Use DisorderAlcohol Related Liver DiseaseLiver Transplant Recipient
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Peer Support

    Behavioral

    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.

Treatment groups

95 Participants
are divided into 1 treatment group
Group A: Peer Support Specialist (PSS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Alcohol Consumption

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

Secondary outcomes

1

Liver Transplant Medical Treatment Engagement

Proportion of kept/scheduled LT follow-up medical appointments

Time frame
Up to 1 year
2

Overall Post-Liver Transplant Survival

All-cause mortality

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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