Digital Pill System for Acamprosate Adherence in Alcohol-Associated Liver Disease
This study is testing a new digital pill system called AcamproSync to help people with Alcohol Use Disorder (AUD) and Alcohol-Associated Liver Disease (ALD) take their acamprosate medication as prescribed. Acamprosate is a medication used to treat AUD. AcamproSync uses a special pill system that tracks when you take your medication, combined with personalized support based on cognitive behavioral therapy (CBT). The goal is to see if this system is practical and acceptable for patients, and if it can help them take their medication more consistently. Researchers will also look at how it affects drinking days and days of not drinking alcohol. You may be able to join if you are being treated for AUD, have moderate to severe AUD, show signs of ALD, and are starting acamprosate. You cannot join if you are allergic to acamprosate, magnesium, or silver, or have severe kidney problems. The study is currently unclear on its recruitment status.
- Study design
- This is a pilot randomized control trial comparing AcamproSync to usual care, with a planned enrollment of 50 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 30 days after baseline measurements.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Digital Pill System to Measure and Support Acamprosate Adherence in Individuals With Alcohol Associated Liver Disease
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Charlotte Goldfine · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Ability to enroll participants- FeasibilityBaseline and 30 days
Number of participants enrolled out of all screened.
- Retention- FeasibilityBaseline and 30 days
Number of participants enrolled that complete the 30 day follow-up.
- Feasibility of Intervention Measure (FIM)- FeasibilityBaseline 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)- AcceptabilityBaseline 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)- AcceptabilityBaseline 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) - AcceptabilityBaseline 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- UsabilityBaseline 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.