Demonstration of a Digital Care Program for Methamphetamine Use Disorder

项目摘要/摘要 此应用程序响应PA 20-262 for Small Business Innovation Research，阶段I，解决SBA- 批准的NIDA规定的区域2，主题D：“数字健康疗法(例如，作为医疗设备的软件， 医疗设备中的软件)专注于行为健康干预，以减轻SUD的负担。这个 申请者(影响技术公司)，建议审查和确认技术优点和现实世界 Effect APP作为Effect数字护理计划核心组成部分治疗慢性阻塞性肺疾病的可行性 甲基苯丙胺使用障碍(MUD)该项目包括一项临床试验，将收集关于 应用程序在吸引患者并提供治疗组件和服务方面的功能，使用 输出以指导应用程序功能的快速改进(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，以表征他们与患者参与度、参与度和保留率的关系。 有关应用程序可行性/可用性的量化数据将包括应用程序使用统计数据和计划影响数据 结果将包括作为第一阶段参与者的MUD患者的唾液药物测试结果 研究(N=90)。关于影响APP的临床效用(可接受性和满意度)的定性数据和 计划将通过全虚拟焦点小组和启用应用程序的评级量表和调查问卷收集 征求参与者、临床医生和利益相关者的反馈。结果将决定技术 优点/可行性，并将为与结果相关的应用程序和计划的改进提供信息，包括 冰毒的使用。具体目标是：目标1.确定效果的技术优点和可行性 APP及其基于临床结果的真实世界实践中的影响数字护理计划的交付 试验；目标2.确定影响应用程序和影响数字护理计划的组件，这些组件与 患者参与、参与、保留和改变甲基苯丙胺的使用；和目标3.使用结果 反复细化影响APP和护理计划，以改善泥浆治疗向实体化方向发展 商业化。展示Effect数字护理平台的临床实用价值，从而实现更好的 患者的结果可以改善全国160万需要治疗的人的临床护理 泥浆，它将增加机会，为从未接受治疗的数百万用户提供服务。如果显示为 在留住参与者的治疗中，影响APP将是一个重要因素 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.