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: 10541769
• 负责人: Artin Perse
• 金额: $ 5.5万
• 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 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10541769
• 关键词: Adherence; Adolescent; Adult; Age; Anxiety; Attention; Attention deficit hyperactivity disorder; Behavioral; Businesses; Caregiver Burden; Caregiver support; Caregivers; Child; Chronic; Clinical; Clinical Trials; Clip; Complex; Data; Development; Devices; Dose; Elderly; Elements; Engineering; Ensure; Entrepreneurship; Evidence based intervention; Goals; Health; Health Services; Health system; Healthcare; Impulsivity; Industry; Innovation Corps; Intervention; Lead; Market Research; Marketing; Medical Device; Medication Management; Medicine; Mental Depression; Mind; Modeling; Modernization; Monitor; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Overdose; Parents; Patients; Pharmaceutical Preparations; Phase; Primary Prevention; Privatization; Provider; Psychoses; Public Health; Qualitative Research; Randomized Clinical Trials; Reaction; Regimen; Research; Risk; Sampling; Schedule; Secure; Self Management; Services; Ships; Small Business Innovation Research Grant; Stimulant; Substance Use Disorder; Suicide; Supervision; Symptoms; System; Systems Development; Technology; Testing; Time; Youth; abuse liability; adolescent health outcomes; arm; behavioral health; commercialization; consumer product; design; digital; evidence base; experience; family support; feasibility testing; improved; interoperability; medication compliance; medication safety; member; mobile application; multidisciplinary; novel; older patient; parental monitoring; peace; pill; portability; prevent; preventive intervention; product development; programs; prospective; prototype; skills; social stigma; stimulant misuse; 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 (prototype). PillSmart's pocket-sized pill dispenser aims to pre- vent 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 facilitat- ing remote supervision of the stimulant medication regimen. The overarching goal of this project is to develop PillSmart's system as an evidence-based prevention intervention to improve adolescents' health outcomes as they mature into adulthood, reduce caregiver burden, and increase medication adherence and safety. The aims of our SBIR Phase I project are to fully develop a portable, affordable medication manage- ment system, test its usability, and assess its feasibility to facilitate self-management of stimulant medications among adolescents with ADHD, improve medication adherence, and reduce parental caregiver burden. Upon the completion of the milestones in Phase 1, we will be prepared to transition into Phase II of the research where we plan to conduct a multisite randomized clinical trial and to integrate evidence-based behavioral ap- proaches. We anticipate the technology's benefits to apply for adolescents with ADHD and also adolescents with other chronic health conditions (e.g., depression, anxiety, Type-2 diabetes).

PillSmart：摘要 兴奋剂药物可有效减少青少年的冲动和其他多动症症状， 这很重要，因为患有多动症的青少年患药物滥用障碍的风险增加。 青少年不遵守兴奋剂药物的情况很普遍（~47-60%），并且滥用规定的兴奋剂 年轻人中的植物数量正在增加（~5-34%），如果没有足够的保护，这会造成严重的公共卫生问题。 监测父母照顾者的支持、青少年滥用兴奋剂和不遵守规定会增加风险 物质使用障碍、药物过量、精神病和自杀的影响 没有可用的基于证据的工具。 或干预措施被证明可以提高 ADHD 青少年对兴奋剂的依从性并减少误用。 大多数依从性辅助工具（例如，用药提醒应用程序、7 天药丸管理器、智能药帽）都无法广告- 解决兴奋剂潜在的滥用问题，因为它们无法有效控制药物的获取。 致力于提高用药安全性和依从性，但它们是为老年患者设计的，并且 由于它们体积大且重，因此不适合年轻人。我们的试点数据表明，年轻人对此感到担忧。 关于使用药物时其他人的耻辱，以及使用现有分配器可能会阻碍依从性 可能会引起不必要的关注并引发预期的耻辱（即担心/担心 其他人的负面反应）。 PillSmart™ 是一种初级预防干预措施，采用新颖、时尚且谨慎的药丸分配方式 PillSmart 的袖珍药丸分配器旨在预先开发设备（原型开发）和移动应用程序（原型）。 通过安全储存药物并仅在预定时间分配编程剂量来避免滥用。 PillSmart 的互操作移动应用程序旨在通过促进以下方式提高依从性并减轻家长的负担： 该项目的总体目标是开发兴奋剂药物治疗方案的远程监督。 PillSmart 的系统作为一种基于证据的预防干预措施，可改善青少年的健康结果 他们成熟到成年，减轻护理人员的负担，并提高用药依从性和安全性。 我们 SBIR 第一阶段项目的目标是全面开发一种便携式、负担得起的药物管理系统 系统，测试其可用性，并评估其促进兴奋剂药物自我管理的可行性 患有多动症的青少年，提高药物依从性，并减轻父母的负担。 完成第一阶段的里程碑后，我们将准备过渡到第二阶段的研究 我们计划进行多中心随机临床试验并整合基于证据的行为应用程序 我们预计该技术将给患有多动症的青少年带来好处。 患有其他慢性健康状况（例如抑郁、焦虑、2 型糖尿病）。