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 兴奋剂药物在减少冲动和其他多动症症状的年轻人， 这一点很重要，因为患有多动症的青少年患药物使用障碍的风险增加。 青少年对兴奋剂药物的不依从性很普遍（约47-60%），滥用处方兴奋剂的情况也很普遍。 青年人中的lants正在增加（~5-34%），这构成了严重的公共卫生问题。没有足够 监测父母照顾者的支持，滥用兴奋剂和青少年不遵守可增加风险 滥用药物过量精神病和自杀倾向没有可用的循证工具 或干预措施证明，以提高兴奋剂的坚持和减少滥用青少年多动症。 大多数粘附辅助工具（例如，药物提醒应用程序，7天药丸组织者，智能药丸帽）未能广告- 处理兴奋剂的潜在滥用，因为它们不能规范药物的获取。药丸分配器是有效的- 有助于提高用药安全性和依从性，但它们是为老年人/老年患者设计的， 由于它们的体积大而重，它们不适合年轻人。我们的试点数据表明， 关于使用他们的药物时来自他人的耻辱，使用目前的配药器可能会阻碍adher- 通过潜在地引起不必要的关注和触发预期的耻辱（即，担心/担心 其他人的负面反应）。 PillSmart™是一种一级预防干预措施，使用新颖、时尚和谨慎的药丸分发 设备（原型开发）和移动的应用程序（原型）。PillSmart的口袋大小的药丸分配器旨在预- 通过安全地储存药物并仅在预定时间分配设定的剂量来避免误用。 PillSmart的互操作移动的应用程序旨在通过促进以下方面来提高依从性并减轻父母负担- 对兴奋剂药物治疗方案进行远程监督。该项目的总体目标是开发 PillSmart系统作为一种循证预防干预措施，可改善青少年的健康结果， 他们成熟到成年，减轻照顾者的负担，并增加药物治疗的依从性和安全性。 我们SBIR第一阶段项目的目标是充分开发一种便携式，负担得起的药物管理- 监测系统，测试其可用性，并评估其可行性，以促进自我管理的兴奋剂药物 在患有ADHD的青少年中，提高药物依从性，减轻父母照顾者的负担。后 在第一阶段的里程碑完成后，我们将准备过渡到研究的第二阶段 我们计划进行一项多地点随机临床试验，并整合基于证据的行为评估， 接近我们预计这项技术的好处适用于患有多动症的青少年， 与其他慢性健康状况（例如，抑郁、焦虑、2型糖尿病）。