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Development of Automated Reinforcement Management System (ARMS): Protocol for a Phase I Feasibility and Usability Study

机译:自动化钢筋管理系统(ARMS)的开发:I阶段可行性和可用性研究的协议

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Background Alcohol use is directly related to over 3 million deaths worldwide every year. Contingency management is a cost-effective treatment for substance use disorders; however, few studies have examined its efficacy for alcohol use disorder. Recent technological advances have enabled the combined use of mobile apps and low-cost electronic breathalyzer devices to remotely monitor alcohol use. Leveraging this type of technology, our study group has recently developed an integrated contingency management system that would enable community treatment programs to remotely deliver contingency management to anyone who owns a smartphone. Objective In this paper, we present a full description of our integrated contingency management system, Automated Reinforcement Management System (ARMS), and describe a protocol that will evaluate its feasibility and usability. Methods Initially, 6 clinicians will participate in a 1-hour focus group where the study staff will navigate through ARMS as it would be used by clinicians and patients. Clinicians will provide feedback on the intervention in general, which will be used to modify ARMS to make it more user friendly, time saving, and relevant to treatment. A second focus group will summarize the changes made following the initial clinician feedback and will provide additional input regarding the potential utilization of ARMS. Thereafter, the clinicians’ acceptability of ARMS will be evaluated using the System Usability Scale. Following the clinicians’ assessments of ARMS and final modifications, the system will be evaluated in terms of feasibility and patient usability by using an A-B-A within-subject experimental design wherein 20 treatment-seeking individuals with alcohol use disorder will be recruited. The two A phases (control conditions) will each last 2 weeks, and the B phase (contingency management condition) will last 4 weeks. During all phases, participants will be asked to use the ARMS app to submit three breathalyzer samples per day (at 10 AM, 2 PM, and 8 PM). Participants will be prompted by the ARMS app at these predetermined times to record and submit their breathalyzer samples. During the A phases, participants will earn vouchers for every breathalyzer sample submitted, independent of their sample results. During the B phase, vouchers will be provided contingent upon the submission of alcohol-negative breathalyzer samples (breath alcohol content = 0.00). At the end of the A-B-A experiment trial, patients’ usability of the ARMS app will be evaluated using the System Usability Scale. Feasibility will be measured based on whether the ARMS app helped significantly increase alcohol abstinence. Results Recruitment for this study began in January 2021 and is expected to be completed by December 2021. Conclusions This study will provide the baseline capability for the implementation of a remotely monitored contingency management platform. If successful, ARMS has the potential to provide effective treatment for alcohol use disorders to individuals living in remote rural areas.
机译:背景技术酒精用途每年直接与全球超过300万人死亡。应急管理是对物质使用障碍的经济有效的治疗方法;然而,很少有研究检测过其对酒精使用障碍的疗效。最近的技术进步使得组合使用移动应用和低成本电子呼吸器设备来远程监控酒精使用。我们的研究组利用这种技术,最近开发了一个综合的应急管理系统,使社区治疗计划能够远程向拥有智能手机的人提供应急管理。目的在本文中,我们全面描述了我们的集成应急管理系统,自动化钢筋管理系统(武器),并描述了一个评估其可行性和可用性的协议。方法最初,6名临床医生将参加1小时的焦点集团,研究人员将通过临床医生和患者使用的武器。临床医生将提供有关干预的反馈,将用于修改武器以使其更加用户友好,节省时间和与治疗相关。第二个焦点小组将总结初始临床医生反馈后所做的变化,并将提供关于武器潜在利用的额外输入。此后,使用系统可用规模评估临床医生的武器可接受性。在临床医生对武器和最终修改的评估之后,将通过使用A-B-A内的可行性实验设计来评估该系统,其中通过在受试者内的实验设计内,其中将招募具有酒精使用障碍的20个治疗个体。两个阶段(控制条件)将每个阶段(控制条件)持续2周,B相(应急管理条件)将持续4周。在所有阶段,将要求参与者使用ARMS应用程序每天提交三个呼吸厅样品(上午10点,下午2点和晚上8点)。参与者将在这些预定时间提示武器应用程序,以记录并提交呼吸厅样品。在阶段,参与者将为每个呼吸厅样本赚取优惠券,与其样本结果无关。在B阶段期间,将在提交酒精阴性呼吸仪样品(呼吸醇含量= 0.00)后提供优惠券。在A-B-A实验试验结束时,将使用系统可用性规模评估患者的臂应用的可用性。将根据手臂应用是否有助于显着增加酒精禁欲来衡量可行性。结果招聘本研究于2021年1月开始,预计将于2021年12月完成。结论本研究将为实施远程监测的应急管理平台提供基线能力。如果成功,武器有可能为居住在偏远农村地区的个人提供有效的饮酒障碍。

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