A Digital Pill System to Measure and Support Acamprosate Adherence in Individuals With Alcohol Associated Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Ability to enroll participants- Feasibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being treated for AUD
- •Diagnosed with DSM-5 moderate to severe AUD
- •Screens positive ALD utilizing non-invasive blood tests
- •Planned initiation of acamprosate
排除标准
- •History of hypersensitivity to acamprosate
- •Allergy to magnesium or silver
- •Severe renal impairment (creatinine clearance of 30mL/min or less)
研究组 & 干预措施
AcamproSync
Participants will 1.) use the AcamproSync system which directly measures acamprosate adherence, 2) receive 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.
干预措施: AcamproSync (Device)
Control (Treatment as Usual)
Participants will receive treatment as usual.
结局指标
主要结局
Ability to enroll participants- Feasibility
时间窗: Baseline and 30 days
Number of participants enrolled out of all screened.
Retention- Feasibility
时间窗: Baseline and 30 days
Number of participants enrolled that complete the 30 day follow-up.
Feasibility of Intervention Measure (FIM)- Feasibility
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Heavy drinking frequency(Baseline and 30 days)
- DPS Accuracy(Baseline and 30 days)
- Abstinence frequency(Baseline and 30 days)
- Linkage to AUD treatment(Baseline and 30 days)
- Mean score Alcohol Craving Questionnaire Short Form Revised (ACQ-SF-R)(Baseline and 30 days)
- Acamprosate adherence by self report(Day 30)
- DPS Acamprosate adherence(Day 30)