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| ID | Type | Description | Link |
|---|---|---|---|
| K23AA031068 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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:
Participants will:
Rates of alcohol use disorder and alcohol associated liver disease requiring liver transplantation continue to rapidly rise. Return to alcohol use after liver transplant is associated with increased rates of liver transplant failure and mortality, but there is no evidence-based integrated intervention to address alcohol use disorder in liver transplant recipients. The goal of this pilot feasibility randomized control trial is to address a critical gap in knowledge and care for liver transplant recipients with concurrent alcohol use disorder by developing and pilot testing an integrated liver transplant and alcohol recovery program (ILTARP) consisting of a recovery coach supporting post-transplant alcohol relapse prevention, outreach, and care coordination with the added intervention of access to an active sober community. The investigators will conduct a pilot feasibility study of the newly developed ILTARP intervention testing feasibility, acceptability, and potential effectiveness of ILTARP in the liver transplant clinical setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | The participants in the control arm will work with a recovery coach and have weekly phone calls with the recovery coach. They will visit the clinic every 3 months for an in-person visit and to complete survey measures related to the study. |
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| Intervention | Experimental | The participants in the intervention arm will work with a recovery coach and have weekly phone calls with the recovery coach. They will also have access to an online sober active community that they can use to augment their recovery process. They will visit the clinic every 3 months for an in-person visit and to complete survey measures related to the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online Sober Active Community | Behavioral | Participants will have access to an online sober active community that they can use to augment their recovery process. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, month 3, month 6, month 9, and study end (1 year) |
| 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. | Baseline, month 3, month 6, month 9, and study end (1 year) |
| 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. | Baseline, month 3, month 6, month 9, and study end (1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol use clinically based on lab | the lab test phosphatidylethanol will be used to assess alcohol use | Baseline, month 3, month 6, month 9, and study end (1 year) |
| Alcohol use based on self report |
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Inclusion Criteria for Enrollment:
Exclusion Criteria for Enrollment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leigh Anne Leigh Anne Dageforde, MD, MPH | Contact | 615-322-5000 | la.dageforde@vumc.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
All PID that underlie results in a publication can be shared with proper requests.
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Beginning 3 months and ending 2 years after the publication of results
This de-identified data will be available through the NIH mandatory data share through the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAA-DA). Requests for data sharing will be directed to the NIAAA-DA as the primary mechanism to obtain data.
If unable to be obtained through the NIAAA-DA, a written proposal maybe submitted with planned analyses and use of the data. Each proposal will be reviewed. Only completely de-identified data will be shared. The recipient of the data must have institutional review board approval. There must be an approved and signed data use agreement.
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Recovery coach | Behavioral | Participants will work with a recovery coach including having weekly phone calls with that recovery coach. |
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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.
| Baseline, month 3, month 6, month 9, and study end (1 year) |
| 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. | Baseline, month 3, month 6, month 9, and study end (1 year) |
| engagement in recovery resources | Participants will complete a survey on their engagement in recovery resources. | 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. |
| clinic and lab adherence | The number of missed lab appointments and transplant clinic no-show rates will be calculated from the medical record. | Baseline, month 3, month 6, month 9, and study end (1 year) |
| medication adherence | Tacrolimus levels will be obtained from the medical record to calculate tacrolimus intrapatient variability. | Baseline, month 3, month 6, month 9, and study end (1 year) |