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可能会增加 物质使用障碍、药物过量、精神病和自杀的风险 没有可用的证据- 基于工具或干预措施被证明可以提高青少年对兴奋剂的依从性并减少滥用 患有多动症。 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 通过安全地储存药物并仅按计划分配剂量来防止误用 PillSmart 的互操作移动应用程序旨在通过以下方式提高依从性并减轻家长的负担。 促进对兴奋剂药物治疗方案的远程监督。 开发 PillSmart 系统作为循证预防干预措施，以提高兴奋剂依从性 患有多动症的青少年，减轻父母兴奋剂药物管理的负担，并且从长远来看 术语，减少处方兴奋剂的非医疗使用。 该第一阶段研究现在将开发分配器和应用程序之间系统的互操作性， 对系统进行可用性测试，并进行前瞻性单臂临床试验以确定可行性 我们认为 PillSmart™ 系统将提高用药依从性，防止非医疗用途。 刺激性药物，并减少青少年预期的耻辱。随后的第二阶段研究将进行多项研究。 现场随机临床试验青少年服用兴奋剂，并将整合基于证据的行为 确定 PillSmart™ 是否是一种改善药物治疗的辅助干预措施的口头方法 因此并减少非医疗用途。