RAE Health I-Corps

RAE Health I-Corps

• 批准号: 10045689
• 负责人: STEPHANIE P CARREIRO
• 金额: $ 5.5万
• 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 2020-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10045689
• 关键词: Advisory Committees; Alcohol or Other Drugs use; Algorithms; Biological Markers; Biosensor; Businesses; Clinical; Data; Detection; Devices; Drug usage; Engineering; Evaluation; Event; Geographic Locations; Goals; Health; Health Personnel; Individual; Innovation Corps; Intervention; Leadership; Locomotion; Manuals; Medicine; Monitor; Morbidity - disease rate; Patients; Physical activity; Physiology; Population; Recovery; Relapse; Research; Research Personnel; Research Project Grants; Research Project Summaries; Skin Temperature; Sleep; Small Business Innovation Research Grant; Specific qualifier value; Stress; Substance Use Disorder; Support System; System; Techniques; Technology; Text; Time; User Compliance; Wrist; base; cloud based; craving; digital; high risk; improved; mortality; personalized medicine; relapse risk; sensor; smart watch; smartphone Application; sobriety; stress reduction; success; tool; treatment program; usability; wearable device; wearable sensor technology

! 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, craving 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 and/or Garmin VivoSmart, 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, craving 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 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) Technology Deployment: To deploy and optimize the RAE system in a population of individuals in treatment for substance use disorder and Aim 2) Aim 2: Technology Evaluation and Optimization: To evaluate the compliance, usability and accuracy of the RAE system 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 in Aim 2 which will include sensitivity, specify, accuracy and user compliance targets. 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记录生理学的小型非侵入性设备。 检测药物使用、渴望和压力的数字生物标记的能力，后者预示着药物使用的增加 RAE 旨在利用此功能为康复中的个人创建实时解决方案。 RAE 的组件有： 1) Empatica Embrace 和/或 Garmin VivoSmart，一种类似于腕部安装的传感器 智能手表的外形尺寸，可连续监测皮肤温度、皮肤电活动 (EDA) 和 Embrace 上将嵌入压力、渴望和药物使用的检测算法。 2) RAE 智能手机应用程序 (app)，对于恢复中的个人，该应用程序将被触发。 通过检测 Embrace 上的事件或在需要时由用户手动提供，并将提供多个 注释选项、减压技术以及在预定义中与个人立即联系 通过电话或短信支持系统，该应用程序还将记录睡眠、身体活动和地理位置。 3) 当治疗提供商检测到事件时，RAE 门户将发出警报。 用户的设备，以便有机会进行实时干预，并且还将提供有关用户记录的指标 该研究计划有两个具体目标： 目标 1) 技术部署：部署和优化。 RAE 系统在接受药物滥用障碍治疗的人群中的应用和目标 2) 目标 2： 技术评估和优化：评估 RAE 的合规性、可用性和准确性 为了实现这些目标，研究人员将首先将该技术部署到以下人群中： 恢复并收集有关准确性、可用性和功能的数据（目标 1）。 优化系统并实现目标 2 中的磨石，其中包括灵敏度、指定、准确性和用户 调查人员与监管机构组建了一个领导团队和顾问团队。 将 RAE 开发为工具所需的商业、医学、可穿戴技术和工程专业知识 显着提高药物滥用障碍治疗的成功率，促进持续清醒， 并降低药物滥用复发的发病率和死亡率。 ！