Alcohol Associated Liver Disease, Alcohol Use Disorder, Behavioral Medicine, Medication Adherence, Medications for Alcohol Use Disorder
Conditions
Brief summary
This study seeks to develop and test a novel digital pill system (DPS) that measures real-time medication ingestion and pairs it with a cognitive behavioral therapy (CBT)-based intervention to provide personalized, data-driven adherence support, with the long-term goal of providing new and improved personalized support and increase medication adherence for people with AUD and ALD.
Detailed description
The primary objective is to develop and examine the feasibility and acceptability of AcamproSync, an adherence intervention that combines a digital pill system (DPS) technology with personalized adherence feedback and support. This intervention aims to improve acamprosate adherence in patients with alcohol use disorder and alcohol-associated liver disease. A pilot randomized control trial of AcamproSync compared to treatment as usual will be conducted to assess the feasibility and acceptability of the adherence intervention paired with DPS (AcamproSync). Secondarily, change in adherence, number of days drinking, and number of days abstinent will be explored. The study will take place at Yale New Haven Hospital, among people with alcohol use disorder and alcohol-associated liver disease.
Interventions
DEVICEAcamproSync
AcamproSync, is an innovative behavioral intervention to support acamprosate adherence in individuals with ALD. It comprises three components: 1) a digital pill system that directly measures acamprosate adherence, 2) a personalized, adherence intervention grounded in the empiric LifeSteps Cognitive Behavioral Therapy framework and 3) self-management and introspection into alcohol use patterns through ecological momentary assessments (EMA) of drinking and alcohol craving.
Sponsors
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants with alcohol use disorder and alcohol-associated liver disease
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Being treated for AUD * Diagnosed with DSM-5 moderate to severe AUD * Screens positive ALD utilizing non-invasive blood tests * Planned initiation of acamprosate
Exclusion criteria
* History of hypersensitivity to acamprosate * Allergy to magnesium or silver * Severe renal impairment (creatinine clearance of 30mL/min or less)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to enroll participants- Feasibility | Baseline and 30 days | Number of participants enrolled out of all screened. |
| Retention- Feasibility | Baseline and 30 days | Number of participants enrolled that complete the 30 day follow-up. |
| Feasibility of Intervention Measure (FIM)- Feasibility | Baseline and 30 days | Feasibility of intervention measured using Feasibility of Intervention Measure (FIM)- a 4-item instrument to assess perceived intervention feasibility. Total score 1-5 with higher scores indicating greater feasibility. |
| Acceptability of Intervention (AIM)- Acceptability | Baseline and 30 days | Treatment Acceptability will be measured using the Acceptability of Intervention Measure (AIM), a 4-item measure of perceived intervention acceptability. Total score 1-5 with higher scores indicating greater acceptability. |
| Mean score Post-Study System Usability Questionnaire (PSSUQ)- Acceptability | Baseline and 30 days | PSSUQ a 16-item standardized questionnaire. Total scores ranging from 1 to 7, where lower scores indicate better user satisfaction and usability. |
| Mean score Health Information Technology Usability Evaluation Scale (Health-ITUES) - Acceptability | Baseline and 30 days | Health-ITUES is a 20-item scale that measures technology usability. Total score range 1-5 with higher scores indicating better usability |
| Mean System Usability Scale (SUS) score- Usability | Baseline and 30 days | SUS is a reliable, 10-item questionnaire used to measure the subjective usability of products, websites, or software, producing a score from 0 to 100. Higher scores indicate more usability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DPS Accuracy | Baseline and 30 days | Correlation coefficient between DPS recorded adherence and pill counts. |
| Heavy drinking frequency | Baseline and 30 days | Mean days heavy drinking in the last thirty days |
| Abstinence frequency | Baseline and 30 days | Mean days drinking abstinence in the last thirty days |
| Linkage to AUD treatment | Baseline and 30 days | Binary yes/no indicating if an individual was linked to further treatment post-inpatient treatment |
| Mean score Alcohol Craving Questionnaire Short Form Revised (ACQ-SF-R) | Baseline and 30 days | Mean score from 1 to 7 with higher scores indicating more severe alcohol craving. |
| Acamprosate adherence by self report | Day 30 | Self report pill counts at the 30 day visit |
| DPS Acamprosate adherence | Day 30 | DPS report pill counts at the 30 day visit |
Countries
United States
Contacts
CONTACTCharlotte Goldfine, MD
PRINCIPAL_INVESTIGATORCharlotte Goldfine
Yale University
Outcome results
None listed