Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease

大脑安全：消费者干预减少与阿尔茨海默氏病相关药物的接触

• 批准号: 10620847
• 负责人: Richard J Holden
• 金额: $ 68.37万
• 依托单位: TRUSTEES OF INDIANA UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-15 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10620847
• 关键词: Academy; Aging; Alzheimer' s Disease; Alzheimer' s disease related dementia; Alzheimer' s disease risk; American; Anti-Cholinergics; Awareness; Behavior Therapy; Brain; Caring; Case/Control Studies; Clinic; Cognitive; Communities; Data; Development; Dose; Drug Exposure; Drug Prescriptions; Elderly; Enrollment; Exposure to; Feeling; Financial Hardship; Geriatrics; Health; Health system; Impaired cognition; Indiana; Intervention; Intervention Studies; Link; Measures; Medicine; Modeling; Multimedia; Neurology; Outcome; Participant; Pathway interactions; Patient Care; Patients; Performance; Pharmaceutical Preparations; Pharmacists; Pharmacy facility; Physicians; Prevalence; Primary Health Care; Public Health; Randomized; Randomized, Controlled Trials; Records; Reporting; Research; Risk; Societies; System; Technology; Testing; Time; Universities; Work; assessment application; attentional control; cerebral atrophy; cognitive function; cognitive load; comparison intervention; cost; cost effective intervention; dementia risk; design; digital; effectiveness evaluation; efficacy testing; empowerment; feasibility testing; feasibility trial; health assessment; health related quality of life; high risk; imaging study; innovation; intervention delivery; medication safety; memory care; mild cognitive impairment; mobile application; modifiable risk; pharmacologic; primary care clinic; primary outcome; secondary outcome; stem; usability; user centered design; willingness

PROJECT SUMMARY/ABSTRACT One in three older Americans is prescribed a strong anticholinergic medication, despite anticholinergics being contraindicated for older adults on the basis of considerable evidence linking use of anticholinergics with cognitive impairment, Alzheimer's disease, and related dementias. National entities including the National Academy of Medicine call for research on interventions to reduce anticholinergic exposure among older adults, as a risk factor for Alzheimer's disease that is amenable to behavioral intervention. We know of no intervention studies directly targeting consumers of anticholinergics. In prior work, we demonstrated the ability to reduce anticholinergics use by older adults by having a geriatrician deliver the intervention directly to consumers. While successful in reducing the proportion of anticholinergic users by 52%, this and other interventions delivered by a physician or pharmacist are expensive and not scalable. Our proposed study tests the efficacy of a consumer intervention, the digital Brain Safe mobile app, a low- cost, scalable mobile application designed by our interdisciplinary team of experts on medication safety, aging, and user-centered design of technology for older adults. The intervention integrates a personalized anticholinergic risk calculator, targeted multimedia content, and a conversation starter to help patients to self- initiate anticholinergic de-prescribing with a clinician. In a feasibility trial of Brain Safe with 17 older adults using at least one strong anticholinergic, 100% of participants reported feeling better informed about medication safety after using Brain Safe, 94% reported planning to speak to a physician about their anticholinergic risk, and 88% did so (confirmed by physician in 82% of cases). Usability testing with 34 older adults showed an “Excellent” usability grade (median System Usability Score = 82.5). In the proposed study, a randomized controlled trial is planned to primarily test the impact of Brain Safe on prescription anticholinergic exposure among older adults at 12 months after intervention. Secondarily, we will test the impact of Brain Safe on cognitive function and health-related quality of life at 12 months. We will explore early effects of Brain Safe on these primary and secondary outcomes at 6 months. Older adult participants will be randomized to receive Brain Safe or an attention control app (WebMD Health Assessment) for 12 months. A total of 700 participants will be enrolled over a 42-month period from a large pool of patients receiving primary healthcare at Eskenazi Health and Indiana University Health. Assessments will be performed at baseline, 6, and 12 months. We will use t tests and mixed effects models to test hypotheses comparing the two conditions on exposure to strong anticholinergics at 12 months. The trial is powered on the primary outcome of anticholinergic exposure at 12 months, assessed by dispensing records. Because anticholinergic drug exposure is a modifiable risk factor for Alzheimer's disease and related dementias, scalable interventions to reduce older adult exposure to anticholinergics are urgently needed.

项目总结/摘要 三分之一的美国老年人被开了一种强效抗胆碱能药物， 根据大量证据，老年人禁用抗胆碱能药物， 认知障碍、阿尔茨海默病和相关痴呆症。国家实体，包括 医学院呼吁研究干预措施，以减少老年人的抗胆碱能药物暴露， 作为老年痴呆症的危险因素，可以通过行为干预来治疗。 我们知道没有直接针对抗胆碱能药物消费者的干预研究。在之前的工作中，我们 证明了通过让老年病学家提供 直接干预消费者。虽然成功地将抗胆碱能药物使用者的比例降低了52%， 由医生或药剂师提供的这种和其它干预是昂贵的并且不可扩展。 我们提出的研究测试了消费者干预的有效性，数字大脑安全移动的应用程序，一个低- 成本，可扩展的移动的应用程序由我们的跨学科专家团队设计的药物安全，老化， 和以用户为中心的技术设计。干预措施整合了个性化的 抗胆碱能药物风险计算器，有针对性的多媒体内容，和对话启动器，以帮助患者自我- 开始与临床医生取消抗胆碱能药物处方。在一项脑安全的可行性试验中，17名老年人使用 至少有一种强效抗胆碱能药物，100%的参与者报告对药物有更好的了解 使用Brain Safe后的安全性，94%的人报告计划与医生讨论他们的抗胆碱能风险， 88%的人这样做（82%的病例经医生证实）。对34名老年人的可用性测试显示， “优秀”可用性等级（系统可用性评分中位数= 82.5）。 在拟议的研究中，计划进行一项随机对照试验，主要测试Brain Safe对 干预后12个月老年人的处方抗胆碱能药物暴露。其次，我们将 测试Brain Safe对12个月认知功能和健康相关生活质量的影响。我们将 在6个月时探索Brain Safe对这些主要和次要结局的早期影响。年长成年人 参与者将随机接受Brain Safe或注意力控制应用程序（WebMD健康评估） 12个月在42个月的时间内，将从大量患者中招募总计700名参与者 在埃斯肯纳齐健康中心和印第安纳州大学健康中心接受初级保健。将进行评估 在基线、6个月和12个月时。我们将使用t检验和混合效应模型来检验假设， 在12个月时暴露于强抗胆碱能药物的两种情况。试验由主电源供电 12个月时抗胆碱能药物暴露的结局，通过分发记录评估。 因为抗胆碱能药物暴露是阿尔茨海默病和相关疾病的一个可改变的风险因素， 因此，迫切需要采取可扩展的干预措施，减少老年人接触抗胆碱能药物。