Intervention for Alcohol Use Disorder Recovery After Liver Transplantation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorLeigh Anne Dageforde
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Online Sober Active Community
BehavioralParticipants will have access to an online sober active community that they can use to augment their recovery process.
Recovery coach
BehavioralParticipants will work with a recovery coach including having weekly phone calls with that recovery coach.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: InterventionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Acceptability of ILTARP (The perception that ILTARP is palatable, agreeable, or satisfactory)
Measured by the Acceptability of Intervention Measure (AIM) survey. The scale ranges from 3 to 15 with a high score indicating greater acceptability.
Time frame
Baseline, month 3, month 6, month 9, and study end (1 year)2
Feasibility of ILTARP (the degree to which ILTARP can be carried out successfully)
Measured by the Feasibility of Intervention Measure (FIM) survey. The scale ranges from 3 to 15 with a high score indicating greater feasibility.
Time frame
Baseline, month 3, month 6, month 9, and study end (1 year)3
Appropriateness of ILTARP (ILTARP suitability and relevance)
Measured by the Intervention Appropriateness Measure (IAM).The scale ranges from 3 to 15 with a high score indicating greater appropriateness.
Time frame
Baseline, month 3, month 6, month 9, and study end (1 year)Secondary outcomes
1
Alcohol use clinically based on lab
the lab test phosphatidylethanol will be used to assess alcohol use
Time frame
Baseline, month 3, month 6, month 9, and study end (1 year)2
Alcohol use based on self report
Alcohol use will be self reported using the Alcohol Use Disorders Identification (AUDIT-C) scale. The scale ranges from 0 to 12 with 0 being the lowest amount of alcohol and 12 being the most amount of alcohol.
Time frame
Baseline, month 3, month 6, month 9, and study end (1 year)3
Alcohol cravings based on self report
Alcohol cravings will be self reported using the Penn Alcohol Craving Scale (PACS). Scale score ranges from 0-30 with 0 being the least amount of cravings and 30 the most.
Time frame
Baseline, month 3, month 6, month 9, and study end (1 year)4
engagement in recovery resources
Participants will complete a survey on their engagement in recovery resources.
Time frame
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Leigh Anne Dageforde
Lead sponsor
Vanderbilt University Medical Center
Sponsor institution
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: