Danielsson Anna-Karin, Lundin Andreas, Andréasson Sven
Department of Public Health Sciences, Karolinska Institutet, SE-171 77, Stockholm, Sweden.
Center for Psychiatric Research, Stockholm, Sweden.
Trials. 2018 Dec 29;19(1):709. doi: 10.1186/s13063-018-3137-y.
A primary concern within the healthcare system is to make treatment more accessible as well as attractive for the great majority of alcohol-dependent people who feel reluctant to participate in the treatment programs available. This paper presents the protocol for a randomized controlled trial (RCT) to test the efficacy of two different technical devices (mobile phone application and breathalyzer) on alcohol consumption.
The study is a three-armed RCT with follow-ups 3 and 6 months after randomization. In total, 375 adults (age 18+ years) diagnosed with alcohol use disorder (AUD) will be invited to participate in a 3-month intervention. The primary outcome is the number of days with heavy drinking, defined as four or more standard drinks (12 g alcohol/drink) and measured by the timeline follow back (TLFB) and Alcohol Use Disorder Identification Test (AUDIT) instruments at 3-month and 6-month follow-up. Secondary outcome measures include weekly alcohol consumption, measured by the TLFB, AUDIT, and phosphatidylethanol in blood values at 3-month and 6-month follow-up (number of days with blood alcohol concentration levels exceeding 60 mg/100 ml).
Improving ways of collecting data on alcohol consumption, as well as the treatment system with regards to AUD, is of vital importance. Mobile phone technology, with associated applications, is widely recognized as a potentially powerful tool in the prevention and management of disease. This study will provide unique knowledge regarding the use of new technology as instruments for measuring alcohol consumption and, also, as a possible way to decrease it.
ISRCTN, ISRCTN14515753 . Registered on 31 May 2018.
医疗保健系统的一个主要关注点是，让绝大多数不愿参与现有治疗项目的酒精依赖者更容易获得治疗，并且让治疗更具吸引力。本文介绍了一项随机对照试验（RCT）的方案，以测试两种不同技术设备（手机应用程序和呼气酒精含量测定仪）对酒精消费的疗效。
该研究是一项三臂随机对照试验，随机分组后3个月和6个月进行随访。总共将邀请375名被诊断患有酒精使用障碍（AUD）的成年人（年龄18岁及以上）参加为期3个月的干预。主要结局是重度饮酒天数，定义为饮用四杯或更多标准饮品（每杯含12克酒精），并在3个月和6个月随访时通过时间线追溯法（TLFB）和酒精使用障碍识别测试（AUDIT）工具进行测量。次要结局指标包括3个月和6个月随访时通过TLFB、AUDIT以及血液中磷脂酰乙醇值测量的每周酒精消费量（血液酒精浓度水平超过60毫克/100毫升的天数）。
改进收集酒精消费数据的方法以及有关酒精使用障碍的治疗系统至关重要。手机技术及其相关应用程序被广泛认为是疾病预防和管理中潜在的强大工具。本研究将提供关于使用新技术作为测量酒精消费的工具以及作为减少酒精消费可能途径的独特知识。
ISRCTN，ISRCTN14515753。于2018年5月31日注册。
