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.

项目摘要 SBIR提交中概述的研究项目将发展实现，分析，参与（RAE） 平台成为一种促进接受药物使用障碍治疗的个体持续恢复的工具。 在此提案中，调查人员打算部署由可穿戴传感器组成的RAE系统 智能手机应用程序以及临床门户 - 可为康复中的个人及其治疗提供者提供 确定救济高风险并获得实时干预机会的机会。 可穿戴生物传感器是不断记录生理学的小型无创设备。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，后者的预示风险增加了 复发。 RAE旨在利用此能力为康复中的个体创建实时解决方案。这 Rae的组件是：1）empatica拥抱，腕部载有腕部传感器的外形与智能相似 观察，连续监视皮肤温度，电肌活动（EDA）和运动。检测 压力和吸毒的算法将嵌入拥抱固件中。 2）RAE智能手机 应用程序（应用程序），用于恢复中的个人。该应用程序将通过检测到事件的检测而触发 在需要时用户拥抱或手动手动，并将为注释提供多种选择 通过呼叫或SMS，减少技术并立即与预定义支持系统中的个人接触 文本。该应用程序还将记录事件的睡眠，体育活动和地理位置。 3）Rae Portal，for 治疗提供商将在用户设备上检测到事件时立即发出警报 实时干预的机会，还将提供有关用户录制活动的指标。 研究计划有两个具体的目标：目标1）在人群中部署和优化RAE系统 接受药物使用障碍治疗的人2）证明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 恢复和收集准确性，可用性和功能的数据中的技术 （目标1）。 AIM 1的数据将用于优化系统并在过渡到之前实现磨石 AIM 2将包括灵敏度，指定，准确和用户合规性目标。然后调查人员将 进行多站点，随机对照试验（AIM 2），以评估RAE对关键结果的效率 包括退休率，在治疗计划中的保留和社会心理健康。调查人员 已经组建了一个领导团队和咨询团队，拥有商业，医学的必要专业知识， 可穿戴技术和工程技术将RAE开发成一种工具，该工具极大地改善了 治疗药物使用障碍，促进持续清醒，并降低 复发到药物使用。