Demonstration of a Digital Care Program for Methamphetamine Use Disorder

项目总结/摘要 本申请响应PA 20 - 262小型企业创新研究，第一阶段，解决SBA- 批准的NIDA指定的区域2，主题D："数字健康治疗学（例如，作为医疗器械的软件， 医疗器械软件）专注于行为健康干预，以减轻SUD的负担。的 申请人（Affect Technologies，Inc.），建议审查和确认技术优点和现实世界 Affect应用程序作为Affect数字护理程序的核心组件用于治疗以下疾病的可行性 甲基苯丙胺使用障碍（MUD）。该项目包括一项临床试验，该试验将收集有关 应用程序在吸引患者和提供治疗组件和服务方面的功能，使用 用于指导应用程序功能的快速细化的输出（例如，主动和被动数据收集，患者 推理引擎、用于临床医生动作的触发器和用户界面）。该项目将分析这些和其他 应用程序的各个方面，以表征其与患者参与、参与和保留的关系。 关于应用程序可行性/可用性的定量数据将包括应用程序使用统计数据和关于计划影响的数据 结果将包括作为I期参与者的MUD个体的唾液药物测试结果 研究（N = 90）。Affect应用程序临床实用性（可接受性和满意度）的定性数据， 该计划将通过全虚拟焦点小组和应用程序支持的评级量表和问卷收集 从参与者、临床医生和利益相关者那里获得反馈。结果将决定技术 优点/可行性，并将告知与结果相关的应用程序和计划的改进，包括 使用冰毒具体目标是：目标1。确认Affect的技术优点和可行性 应用程序及其在现实世界实践中的影响数字护理计划的交付，基于临床结果， 试验;目标2.识别与以下内容相关的Affect应用程序和Affect数字护理程序的组件 患者的参与，参与，保留和甲基苯丙胺使用的变化;和目标3。使用结果 迭代完善Affect应用程序和护理计划，以改善MUD的治疗， 商业化展示Affect数字护理平台的临床实用性， 患者的治疗结果可以改善全国160万需要治疗的人的临床护理， 它将增加为从未接受治疗的数百万用户提供服务的机会。如果显示为 在留住治疗参与者方面可行且有效，Affect应用程序将成为 以合理的成本有效地实现最佳的患者结果。

Project Summary / Abstract This application responds to PA 20-262 for Small Business Innovation Research, Phase I, addressing SBA- approved NIDA-specified Area 2, Topic D: “Digital health therapeutics (e.g., Software as Medical Device, Software in Medical Device) focused on behavioral health interventions to alleviate the burden of SUD.” The applicants (Affect Technologies, Inc.), propose to examine and confirm the technical merit and real-world feasibility of the Affect app as the core component of the Affect digital care program for treatment of methamphetamine use disorder (MUD). The project includes a clinical trial that will assemble data on the functionality of the app in engaging patients and delivering treatment components and services, using outputs to guide rapid refinements of the app’s functions (e.g., active and passive data collection, patient inference engine, triggers for clinician actions, and user interfaces). The project will analyze these and other aspects of the app to characterize their relationships with patient engagement, participation, and retention. Quantitative data on app feasibility/usability will include app usage statistics, and data on program impacts on outcomes will consist of results of saliva drug tests of individuals with MUD as participants in the Phase I research (N=90). Qualitative data on the clinical utility (acceptability and satisfaction) of the Affect app and program will be collected via all-virtual focus groups and app-enabled rating scales and questionnaires eliciting feedback from participants, clinicians, and stakeholders. Results will determine technical merit/feasibility and will inform refinements to the app and program correlated with outcomes, including methamphetamine use. Specific aims are to: Aim 1. Confirm the technical merit and feasibility of the Affect app and its delivery of the Affect digital care program in real-world practice based on results from the clinical trial; Aim 2. Identify components of the Affect app and the Affect digital care program that correlate with patient engagement, participation, retention, and changes in methamphetamine use; and Aim 3. Use results to iteratively refine the Affect app and care program to improve treatment of MUD toward substantiating commercialization. Demonstrating the clinical utility of the Affect digital care platform leading to better patient outcomes could improve clinical care for the 1.6 million people in the nation who need treatment for MUD, and it would increase access to serve the million users who never receive treatment. If shown to be feasible and effective in retaining participants in treatment, the Affect app will be an important element in efficiently achieving optimum patient outcomes at reasonable cost.