RAE (Realize, Analyze, Engage)- A Digital Biomarker Based Detection and Intervention System for Stress and Craving During Recovery from Substance Abuse Disorders

项目摘要 SBIR提交的研究项目将开发实现，分析，参与（RAE） 平台转化为工具，以促进接受药物使用障碍治疗的个人的持续康复。 在这项提案中，研究人员打算部署RAE系统-由可穿戴传感器， 智能手机应用程序和临床门户-为康复中的个人及其治疗提供者提供 有机会确定复发的高风险时刻，并获得真实的时间干预机会。 可穿戴生物传感器是一种小型、非侵入性的设备，可以连续记录生理状态。这些传感器具有 检测药物使用和压力的数字生物标志物的能力，后者预示着增加的风险， 复发RAE旨在利用这一能力为恢复中的个人创建实时解决方案。的 RAE的组成部分是：1）Empatica Embrace，一种手腕安装的传感器，外形与智能手机相似， 手表，持续监测皮肤温度，皮肤电活动（EDA）和运动。检测 压力和药物使用的算法将嵌入到Embrace固件中。2)RAE智能手机 应用程序（App），用于恢复中的个人。应用程序将通过检测到 拥抱或手动由用户在需要时，并将提供多种选项的注释，强调 减少技术和通过电话或短信与预定义支持系统中的个人立即联系 短信了该应用程序还将记录睡眠，身体活动和事件的地理位置。3)RAE门户网站， 当在用户设备上检测到事件时，治疗提供者将立即发出警报， 这将提供真实的时间干预的机会，并且还将提供关于用户的记录活动的度量。的 研究计划有两个具体目标：目标1）在人口中部署和优化RAE系统， 2）证明研究、咨询和教育系统的影响 药物使用治疗的结果。为了实现这些目标，调查人员将首先部署 技术在个人群体中恢复和收集关于准确性、可用性和功能性数据 (Aim 1）。目标1的数据将用于优化系统，并在过渡到 目标2包括敏感性、具体说明、准确性和用户依从性目标。调查人员将 进行多中心随机对照试验（目标2），以评估RAE对关键结局的疗效 包括复发率、治疗方案的保留率和心理社会健康。调查人员 已经组建了一个领导团队和咨询团队，他们在商业，医学， 可穿戴技术和工程开发RAE成为一种工具，大大提高了成功的 治疗物质使用障碍，促进持续清醒，并减少发病率和死亡率， 吸毒复发

PROJECT SUMMARY The research project outlined in this SBIR submission will develop the Realize, Analyze, Engage (RAE) platform into a tool to promote sustained recovery in individuals receiving treatment for substance use disorder. In this proposal, the investigators intend to deploy the RAE system- consisting of a wearable sensor, a smartphone app, and a clinical portal- to provide individuals in recovery and their treatment providers with an opportunity to identify moments of high risk for relapse and to access real time intervention opportunities. Wearable biosensors are small, noninvasive devices that continuously record physiology. These sensors have the ability to detect digital biomarkers of drug use and stress, the latter of which herald an increased risk of relapse. RAE aims to utilize this capability to create a real-time solution for individuals in recovery. The components of RAE are: 1) The Empatica Embrace, a wrist mounted sensor similar in form factor to a smart watch, that continuously monitors skin temperature, electrodermal activity (EDA) and locomotion. Detection algorithms for stress and drug use will be embedded on the Embrace firmware. 2) The RAE smartphone application (app), for the individual in recovery. The app will be triggered either by detection of an event on the Embrace or manually by the user when needed and will provide multiple options for annotations, stress reduction techniques and immediate contact with individuals in the pre-defined support system via call or SMS text. The app will also log sleep, physical activity, and geographic location of events. 3) The RAE Portal, for the treatment provider, will deliver immediate alerts when an event is detected on the user’s device for the opportunity to intervene in real time and will also provide metrics on the user’s recorded activities. The research plan has two Specific Aims: Aim 1) To deploy and optimize the RAE system in a population of individuals in treatment for substance use disorder and Aim 2) To demonstrate the impact of the RAE system on outcomes in substance use treatment. To achieve these aims the investigators will first deploy the technology in a population of individuals in recovery and collect data on accuracy, usability and functionality (Aim 1). The data from Aim 1 will be used to optimize the system and achieve millstones prior to transition to Aim 2 which will include sensitivity, specify, accuracy and user compliance targets. The investigators will then undertake a multi-site, randomized controlled trial (Aim 2) to evaluate the efficacy of RAE on key outcomes including rates of relapse, retention in treatment programs, and psychosocial wellbeing. The investigators have assembled a leadership team and advisory team with the necessary expertise in business, medicine, wearable technology and engineering to develop RAE into a tool that dramatically improves the success of treatment for substance use disorder, promotes sustained sobriety, and reduces morbidity and mortality from relapse to substance use.