Facilitating supervised self-management of stimulant medications among adolescents: improving adherence, reducing stigma, and supporting caregivers

促进青少年兴奋剂药物的监督自我管理：提高依从性、减少耻辱并支持护理人员

• 批准号: 10259063
• 负责人: Artin Perse
• 金额: $ 32.41万
• 依托单位: PILLSMART INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10259063
• 关键词: Adherence; Adolescent; Attention; Attention deficit hyperactivity disorder; Behavioral; Biological; Caregiver Burden; Caregiver support; Caregivers; Child; Child Psychiatry; Clinical Trials; Communication; Computer software; Data; Devices; Dose; Elderly; Engineering; Ensure; Family member; Feedback; Feeling; Goals; Health Services Research; Image; Impulsivity; Intervention; Learning Module; Market Research; Measures; Medical; Medical Device; Medication Management; Modeling; Modification; Monitor; Oral; Outcome; Overdose; Parents; Patient Self-Report; Patients; Pharmaceutical Preparations; Pilot Projects; Primary Prevention; Psychoses; Public Health; Qualitative Research; Randomized Clinical Trials; Reaction; Regimen; Research; Risk; Sampling; Schedule; Secure; Self Management; Site; Substance Use Disorder; Suicide; Supervision; Swab; Symptoms; System; Technology; Testing; Time; Vision; Visual; Youth; addiction; arm; base; contingency management; cost; design; evidence base; experience; expressive writing; feasibility testing; improved; interoperability; mHealth; medication compliance; medication safety; mobile application; multidisciplinary; nonmedical use; novel; older patient; open label; peer; phase 1 study; phase 2 study; pill; prevent; preventive intervention; primary outcome; prospective; prototype; recruit; satisfaction; secondary outcome; shared decision making; social stigma; stimulant misuse; stimulant use; telehealth; tool; usability; willingness to pay

PillSmart: Abstract Stimulant medications are efficacious in reducing impulsivity and other ADHD symptoms in youth, which is important because youth with ADHD have an increased risk of developing substance use disorders. Youth's non-adherence of stimulant medications is prevalent (~47-60%), and the misuse of prescribed stimu- lants is increasing among youth (~5-34%), which poses a serious public health concern. Without adequate monitoring support by parental caregivers, stimulant misuse and non-adherence in youth can increase the risk of substance use disorders, overdose, psychosis, and suicidality. There are no available evidence- based tools or interventions demonstrated to improve stimulant adherence and reduce misuse among youth with ADHD. Most adherence aids (e.g., medication reminder apps, 7-day pill organizers, smart pill caps) fail to ad- dress the potential misuse of stimulants as they cannot regulate medication access. Pill dispensers are effec- tive at improving medication safety and adherence, but they are designed for older adult/elderly patients, and they are not ideal for youth due to their large and heavy size. Our pilot data suggest that youth are concerned about stigma from others when using their medication, and the use of current dispensers could hinder adher- ence by potentially soliciting unwanted attention and triggering anticipated stigma (i.e., worry/concern about negative reactions from others). PillSmart™ is a primary prevention intervention that uses a novel, sleek, and discreet pill dispensing device (prototype developed) and mobile app (to be developed). PillSmart's pocket-sized pill dispenser aims to prevent misuse by securely storing medication and only dispensing the programmed dose at the scheduled time. PillSmart's interoperating mobile app aims to improve adherence and mitigate the parental burden by fa- cilitating remote supervision of the stimulant medication regimen. The overarching goal of this project is to de- velop PillSmart's system as an evidence-based prevention intervention to improve stimulant adherence in youth with ADHD, reduce the parental burden of stimulant medication management, and in the long- term, reduce the non-medical use of prescribed stimulants. This Phase I study will now develop the system's interoperability between the dispenser and the app, conduct usability testing of the system, and conduct a prospective single-arm clinical trial to determine feasibili- ty. We hypothesize that the PillSmart™ system will improve medication adherence, prevent non-medical use of stimulant medication, and reduce anticipated stigma in youth. A subsequent phase II study will conduct a multi- site randomized clinical trial among youth prescribed with stimulants and will integrate evidence-based behav- ioral approaches to determine whether PillSmart™ is an adjunctive intervention that improves medication ad- herence and reduces non-medical use.

Pillsmart：摘要 刺激药有效地减少年轻人的冲动性和其他ADHD症状， 这很重要，因为患有多动症的年轻人患有培养物质使用障碍的风险增加。 青年对刺激药物的不遵守是普遍的（〜47-60％），而对规定​​的刺激物进行了失误 - Lants在青年中正在增加（约5-34％），这引起了严重的公共健康问题。没有足够的时间 监测父母的照顾者的支持，刺激性的小姐和年轻人的不遵守可以增加 物质使用障碍，过量，精神病和自杀的风险。没有可用的证据 - 证明可以提高兴奋剂依从性并减少青年的失误的基于的工具或干预措施 与多动症。 大多数依从性辅助工具（例如，药物提醒应用程序，7天药丸组织者，智能药帽）未能广告 在无法调节药物访问的情况下对潜在的刺激剂的遗物打扮。药丸分配器是有效的 旨在提高药物安全性和依从性，但它们是为老年人/老年患者而设计的， 由于大小的大小，它们对于青年来说并不理想。我们的飞行员数据表明​​年轻人担心 关于他人使用药物时的污名，使用当前分配器可能会阻碍 通过潜在地吸引不必要的关注并引发预期的污名（即担心/担心 他人的负面反应）。 Pillsmart™是一种主要的预防干预措施，使用新颖，时尚和谨慎的药丸分配 设备（开发的原型）和移动应用程序（待开发）。 Pillsmart的袖珍药丸分配器的目的是 通过安全地储存药物并仅在计划的情况下分配程序剂量，以防止MISSIDE 时间。 Pillsmart的互操作移动应用程序旨在提高依从性，并通过FA-来减轻父母的烧伤 对刺激药物方案的远程监督。该项目的总体目标是 Velop Pillsmart的系统作为基于证据的预防干预措施，以提高刺激性粘附 患有多动症的年轻人，减少刺激药物管理的父母燃烧，并在很长一段时间内 术语，减少规定兴奋剂的非医学使用。 这一阶段I研究现在将开发系统之间的系统互操作性，分配器和应用程序之间的互操作性， 对系统进行可用性测试，并进行一项前瞻性的单臂临床试验以确定可行性 泰。我们假设Pillsmart™系统将提高药物依从性，防止非医学使用 刺激性药物，并减少青年人的预期污名。随后的II期研究将进行多个 用兴奋剂准备的年轻人中的现场随机临床试验，并将整合基于证据的行为 - 确定Pillsmart™是否是一种辅助干预措施的Ioral方法 此处并减少非医学使用。