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

RAE（实现、分析、参与）——一种基于数字生物标记的检测和干预系统，用于治疗药物滥用疾病恢复过程中的压力和渴望

• 批准号: 10370419
• 负责人: STEPHANIE P CARREIRO
• 金额: $ 74.2万
• 依托单位: CONTINUEYOU, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-15 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10370419
• 关键词: Advisory Committees; Algorithms; Anxiety; Award; Behavior; Behavior Therapy; Biological Markers; Businesses; Car Phone; Caring; Clinical; Data; Detection; Devices; Disease; Drug usage; Engineering; Environment; Event; Explosion; Foundations; Geographic Locations; Goals; Health; Health Insurance Portability and Accountability Act; Health Personnel; Healthcare; Helping to End Addiction Long-term; Individual; Industry; Intervention; Investigation; Italy; Journals; Leadership; Link; Location; Locomotion; Machine Learning; Manuals; Measures; Medicine; Modeling; Monitor; Morbidity - disease rate; Opiate Addiction; Opioid; Outcome; Participant; Patients; Persons; Physical activity; Physiological; Physiology; Population; Post-Traumatic Stress Disorders; Precipitating Factors; Predisposition; Provider; Psychosocial Factor; Public Health; Publishing; Randomized Controlled Trials; Recovery; Relapse; Research; Research Personnel; Research Project Grants; Research Project Summaries; Resources; Role; Seizures; Sensitivity and Specificity; Site; Skin Temperature; Sleep; Small Business Innovation Research Grant; Specific qualifier value; Speed; Stimulant; Stream; Stress; Substance Use Disorder; Substance abuse problem; Suicide; Support System; System; Techniques; Technology; Text; Time; United States National Institutes of Health; User Compliance; Wrist; active method; addiction; base; cloud based; cost; cost effective; craving; design; digital; efficacy evaluation; experience; handheld mobile device; high risk; improved; machine learning framework; mobile application; mortality; opioid misuse; personalized medicine; prevent; psychosocial wellbeing; randomized controlled study; relapse risk; sensor; service providers; signal processing; smart watch; smartphone Application; sobriety; software development; stem; stress management; stress reduction; substance abuse treatment; substance use; substance use treatment; success; tool; treatment program; usability; wearable device; wearable sensor technology; wireless

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.

项目概要 本 SBIR 提交中概述的研究项目将开发实现、分析、参与 (RAE) 平台转变为促进接受药物滥用障碍治疗的个人持续康复的工具。 在该提案中，研究人员打算部署 RAE 系统，该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 有机会识别复发高风险时刻并获得实时干预机会。 可穿戴生物传感器是小型、无创的设备，可以连续记录生理情况。这些传感器有 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 旨在利用这一功能为康复中的个人创建实时解决方案。这 RAE 的组件包括： 1) Empatica Embrace，一种安装在手腕上的传感器，其外形类似于智能手表 手表，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嵌入 Embrace 固件中。 2）RAE智能手机 应用程序（app），用于康复中的个人。该应用程序将通过检测到事件来触发 需要时由用户拥抱或手动，并会提供多种注释选项，强调 减少技术并通过电话或短信与预定义支持系统中的个人立即联系 文本。该应用程序还将记录睡眠、体力活动和事件的地理位置。 3) RAE 门户网站，用于 当用户设备上检测到事件时，治疗提供者将立即发出警报 实时干预的机会，还将提供有关用户记录的活动的指标。这 研究计划有两个具体目标： 目标 1) 在人群中部署和优化 RAE 系统 接受物质使用障碍治疗的个人和目标 2) 证明 RAE 系统的影响 关于药物滥用治疗的结果。为了实现这些目标，研究人员将首先部署 在恢复中的个体群体中使用技术，并收集有关准确性、可用性和功能的数据 （目标 1）。目标 1 的数据将用于优化系统并在过渡到目标之前实现目标 目标 2 将包括敏感性、规范、准确性和用户合规性目标。调查人员随后将 进行多中心随机对照试验（目标 2）以评估 RAE 对关键结果的功效 包括复发率、治疗方案的保留率以及心理健康状况。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 开发为可显着提高成功率的工具 治疗物质使用障碍，促进持续清醒，并降低发病率和死亡率 再次吸毒。