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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Yale
New Haven, Connecticut, United States
Ability to enroll participants- Feasibility
Number of participants enrolled out of all screened.
Time frame: Baseline and 30 days
Retention- Feasibility
Number of participants enrolled that complete the 30 day follow-up.
Time frame: Baseline and 30 days
Feasibility of Intervention Measure (FIM)- Feasibility
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.
Time frame: Baseline and 30 days
Acceptability of Intervention (AIM)- Acceptability
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.
Time frame: Baseline and 30 days
Mean score Post-Study System Usability Questionnaire (PSSUQ)- Acceptability
PSSUQ a 16-item standardized questionnaire. Total scores ranging from 1 to 7, where lower scores indicate better user satisfaction and usability.
Time frame: Baseline and 30 days
Mean score Health Information Technology Usability Evaluation Scale (Health-ITUES) - Acceptability
Health-ITUES is a 20-item scale that measures technology usability. Total score range 1-5 with higher scores indicating better usability
Time frame: Baseline and 30 days
Mean System Usability Scale (SUS) score- Usability
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.
Time frame: Baseline and 30 days
DPS Accuracy
Correlation coefficient between DPS recorded adherence and pill counts.
Time frame: Baseline and 30 days
Heavy drinking frequency
Mean days heavy drinking in the last thirty days
Time frame: Baseline and 30 days
Abstinence frequency
Mean days drinking abstinence in the last thirty days
Time frame: Baseline and 30 days
Linkage to AUD treatment
Binary yes/no indicating if an individual was linked to further treatment post-inpatient treatment
Time frame: Baseline and 30 days
Mean score Alcohol Craving Questionnaire Short Form Revised (ACQ-SF-R)
Mean score from 1 to 7 with higher scores indicating more severe alcohol craving.
Time frame: Baseline and 30 days
Acamprosate adherence by self report
Self report pill counts at the 30 day visit
Time frame: Day 30
DPS Acamprosate adherence
DPS report pill counts at the 30 day visit
Time frame: Day 30
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