Alcohol Biosensor Monitoring for Alcoholic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Alcohol Use
研究概览
简要总结
Successful treatment of alcohol associated liver disease (AALD) depends primarily on abstinence from alcohol. The investigators propose a randomized clinical trial of alcohol biosensor monitoring for patients with alcohol associated liver disease to determine if monitoring with feedback on alcohol use patterns reduces alcohol consumption and improves outcomes.
详细描述
The investigators propose a 3 month randomized controlled trial (RCT) pilot of alcohol biosensor monitoring (ABM)(WrisTAS) for patients with Alcohol Associated Liver Disease (AALD) who intend to stop drinking. All participants will wear the ABM device but participants will be randomized to receive either personalized feedback on the data recorded on the device (n=30) or enhanced usual care without feedback on device data (n=30). The investigators will determine whether ABM plus feedback improves outcomes for AALD patients compared to enhanced usual care and hypothesize ABM feedback will reduce alcohol consumption, improve motivation and self-efficacy for abstinence and improve engagement in treatment. The investigators will also conduct research including qualitative data collected from participants who will provide opinions on ABM feasibility, acceptability, and usability. Qualitative methods are especially useful for understanding the perceived needs, barriers, and preferences for monitoring alcohol use and are especially required for future translation of this technology into clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Patients with AALD followed at our liver disease clinic,
- •18 years or older,
- •willing to accept randomization,
- •and agree to wear device for 3 months,
- •SOCRATES problem recognition subscale score >26 (scores <26 indicate very low recognition of an alcohol problem).
排除标准
- •Non-English speaking,
- •Montreal Cognitive Assessment (MOCA) scores <21 (moderate cognitive impairment) or neurologic diseases (e.g. Parkinson's),
- •patients with unresponsive acute alcoholic hepatitis, multi-organ failure, fulminant hepatic failure,
- •cancer/terminal illness;
- •those unable to wear a wrist monitor (e.g., edema);
- •lacking a residence, or unable to identify a contact person (if lost to follow-up).
结局指标
主要结局
Alcohol Use
时间窗: continuous for up to 3 months
Average number of drinks per drinking episode per interval (month) of device wear. We analyzed the number of drinks per drinking episode and present the group average per month interval of assessment.
Percent of Days Drinking Per Interval of Device Wear
时间窗: 3 months
Percent of days drinking per interval of device wear: We analyzed the data by number of drinking episodes per individual per days of device wear and present the mean percent days drinking per assessment interval
次要结局
- Improved Readiness for Alcohol Abstinence and Initiation of Change(Scores determined at initiation, 6 weeks and 3 months of participation)
- Self Efficacy to Remain Abstinent(Scores determined at initiation, 6 weeks and 3 months of participation)
- Medical Outcomes(Counts determined at initiation, 6 weeks and 3 months of participation)
- Qualitative Interviews(measured at three months (completion of the participants use of ABM))
研究者
Andrea DiMartini
Professor of Psychiatry and Surgery
University of Pittsburgh