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

项目总结 这份SBIR意见书中概述的研究项目将开发实现、分析、参与(RAE) 将这一平台转变为一种工具，促进接受药物使用障碍治疗的个人的持续康复。 在这项提议中，调查人员打算部署RAE系统--包括一个可穿戴的传感器、一个 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 有机会识别复发的高风险时刻，并获得实时干预机会。 可穿戴式生物传感器是一种小型的非侵入性设备，可以持续记录生理过程。这些传感器有 检测药物使用和压力的数字生物标记物的能力，后者预示着 旧病复发。RAE的目标是利用这一能力为康复中的个人创建实时解决方案。这个 RAE的组件包括：1)Empatica拥抱，一种安装在手腕上的传感器，外形尺寸类似于Smart 手表，它持续监测皮肤温度、皮肤电活动(EDA)和运动。检测 针对压力和药物使用的算法将被嵌入到拥抱固件中。2)RAE智能手机 应用程序(APP)，适用于恢复期的个人。该应用程序将通过检测到 拥抱或用户需要时手动，并将提供多种选项的批注，强调 减少技术，并通过呼叫或短信与预定义支持系统中的个人进行即时联系 文本。该应用程序还将记录睡眠、体力活动和活动的地理位置。3)RAE门户，用于 治疗提供者将在用户的设备上检测到事件时立即发送警报 有机会进行实时干预，还将提供有关用户记录的活动的指标。这个 研究计划有两个具体目标：目标1)在 药物使用障碍治疗中的个人和目标2)展示RAE系统的影响 关于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 技术在恢复中的个人群体中并收集关于准确性、可用性和功能性的数据 (目标1)。来自AIM 1的数据将用于优化系统，并在过渡到 目标2将包括敏感性、具体性、准确性和用户遵从性目标。然后，调查人员将 进行一项多点随机对照试验(目标2)以评估RAE对关键结局的疗效 包括复发率、治疗计划中的保留率和心理社会健康。调查人员 组建了一支领导团队和咨询团队，拥有商业、医学、 可穿戴技术和工程将RAE开发为一种工具，可显著提高 治疗物质使用障碍，促进持续戒酒，并降低 故态复萌地使用物质。

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.