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 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，青少年滥用兴奋剂和不坚持， 物质使用障碍、药物过量、精神病和自杀倾向的风险。没有证据表明- 经证明可改善青少年对兴奋剂的坚持并减少滥用的工具或干预措施 注意力缺陷多动症 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（原型已开发）和移动的应用程序（待开发）。PillSmart的口袋大小的药丸分配器旨在 通过安全地储存药物并仅在预定时间分配编程剂量， 时间PillSmart的互操作移动的应用程序旨在通过以下方式提高依从性并减轻父母的负担： 实现对兴奋剂药物治疗方案的远程监督。该项目的总体目标是- velop PillSmart的系统是一种基于证据的预防干预措施，可提高兴奋剂依从性 青少年多动症，减少父母的负担，兴奋剂药物管理，并在长期- 从长远来看，减少处方兴奋剂的非医疗使用。 第一阶段的研究现在将开发分配器和应用程序之间的系统互操作性， 对系统进行可用性测试，并进行前瞻性单组临床试验，以确定可行性， 泰我们假设PillSmart™系统将改善药物依从性，防止药物的非医疗使用， 兴奋剂药物，并减少预期的青年耻辱。随后的第二阶段研究将进行多- 在服用兴奋剂的青少年中进行现场随机临床试验，并将整合循证医学研究， 通过口服方法确定PillSmart™是否是一种改善药物治疗效果的干预措施， 减少非医疗用途。