Supporting Tailored Adaptive Change and Reinforcement for Medication Adherence Program (STAR-MAP): Randomized trial of a novel approach to improve adherence in older hypertensive women and men

支持定制的适应性改变和强化药物依从性计划 (STAR-MAP)：针对提高老年高血压女性和男性依从性的新方法的随机试验

• 批准号: 10620650
• 负责人: Marie Krousel-Wood
• 金额: $ 76.08万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10620650
• 关键词: Adherence; Adult; Antihypertensive Agents; Attitude; Automobile Driving; Behavior; Behavior Therapy; Blood Pressure; Blue Cross; Blue Shield; Cardiovascular Diseases; Categories; Cause of Death; Chronic Disease; Clinical; Clinical Trials; Conscious; Data; Disease; Drug Prescriptions; Effectiveness; Elderly; Goals; Health; Health behavior; Hypertension; Immunity; Implicit Association Test; Intervention; Intervention Trial; Knowledge; Learning; Louisiana; Mediation; Methods; Modeling; National Heart, Lung, and Blood Institute; Older Population; Outcome; Participant; Patient Self-Report; Personal Satisfaction; Pharmaceutical Preparations; Pilot Projects; Process; Psychological reinforcement; Psychotherapy; Public Health; Quality of life; Race; Randomized; Randomized, Controlled Trials; Research; Research Priority; Resistance; Side; Subconscious; Subgroup; Testing; United States National Institutes of Health; Woman; Work; adherence rate; attentional control; behavior change; behavioral adherence; blood pressure control; blood pressure medication; blood pressure reduction; burden of illness; cardiovascular disorder risk; cardiovascular health; design; disability; efficacy evaluation; evidence base; healthy aging; high risk; hypertensive; improved; innovation; insight; intervention program; medication compliance; medication nonadherence; men; novel; novel strategies; older men; older women; primary outcome; programs; psychologic; racial population; randomized trial; sex; telephone coaching; tool; treatment arm; treatment as usual; trial design

Project summary There is a fundamental gap in the availability of interventions that 1) sustainably improve adherence to pre- scribed blood pressure (BP) medications, 2) identify underlying behavior change mechanisms, and 3) demon- strate efficacy by sex and race in older adults. Accordingly, interventions to improve adherence and BP control remain minimally effective. The long-term goal is to improve medication adherence, BP control, and healthy aging in older hypertensive adults. The overall objective for this R01 application is to determine the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication Adherence Program (STAR- MAP), which integrates the transformative Overcoming Immunity-to-Change (OITC) health coaching process, on improving adherence, BP control, and quality of life (QOL). The OITC approach that has proven useful in other arenas was successfully applied to BP management in the research team's recent pilot study. Based on this prior work, the central hypothesis is that STAR-MAP, designed to help nonadherent older hypertensive adults to identify and alter implicit attitudes that hinder medication adherence, will change mindsets and im- prove daily taking of prescribed medications, leading to lowered BP and better QOL. The rationale for the pro- posed study is that demonstration of the efficacy of STAR-MAP would provide new opportunities to overturn nonadherent behavior and improve BP control and healthy aging for the growing population of older adults with hypertension, overall and in sex and race subgroups. The central hypothesis will be tested by pursuing two specific aims: (1) Determine the efficacy, underlying mechanism, and sustainability of the STAR-MAP interven- tion, aimed at improving medication-taking behavior, on medication adherence and clinical outcomes; and (2) Explore the efficacy of STAR-MAP in sex and race subgroups. Under the first aim, a randomized controlled trial will be conducted in 402 nonadherent (proportion of days covered (PDC) <0.8) adults ≥65 years with un- controlled BP (201 per arm – intervention versus usual care; 50% women; 50% black) and fully insured by Blue Cross Blue Shield of Louisiana. The study will have 90% statistical power to detect a 15% difference at 12 months in the proportion of participants with PDC ≥0.8 between those randomized to intervention versus usual care with attention control. Under the second aim, efficacy of STAR-MAP in sex and race subgroups will be explored. The approach is innovative because it will be the first large clinical trial to rigorously test a new intervention that targets negative implicit attitudes toward medications with a goal to improve adherence, BP control, and QOL. The proposed research is significant because it will represent an important step in a contin- uum of research that is expected to lead to an efficacious, scalable intervention (with data on the underlying behavior change mechanism). Finally, the results are expected to provide new insights on an underappreciated psychological mechanism (i.e., implicit attitudes) of nonadherence that could be useful for improving the effec- tiveness of other medication adherence interventions.

项目总结 在干预措施的可获得性方面存在一个根本性的差距，1)可持续地改善对Pre-Pre 划片的血压(BP)药物，2)确定潜在的行为改变机制，以及3)恶魔- 根据性别和种族对老年人进行疗效评估。因此，改善依从性和BP控制的干预措施 保持最低限度的有效性。长期目标是改善服药依从性、血压控制和健康 老年高血压成人的老龄化。此R01应用程序的总体目标是确定 服药依从性支持量身定制的适应变化和强化计划(STAR- MAP)，其中整合了变革性的克服免疫变化(OITC)健康指导过程， 关于提高依从性、血压控制和生活质量(QOL)。OITC方法在以下方面已被证明有用 在研究小组最近的初步研究中，其他领域也成功地应用于BP管理。基于 这项先前的工作，中心假设是星图，旨在帮助非粘附性老年高血压 成年人识别和改变阻碍服药依从性的内隐态度，将改变人们的心态和行为 证明每天服用处方药可以降低血压，改善生活质量。支持的理由是- 提出的研究是，星图有效性的展示将提供新的机会来颠覆 非依从性行为和改善血压控制以及老年人口的健康老龄化 高血压，总体上，在性别和种族亚组中。核心假说将通过追求两个 具体目标：(1)确定星图干预的有效性、潜在机制和可持续性。 旨在改善服药行为、服药依从性和临床结果的运动；以及(2) 探索星图在性别和种族亚群中的有效性。在第一个目标下，随机对照 试验将在402名未依从者(覆盖天数比例(Pdc&lt；0.8))65岁的成年人中进行，未-≥ 受控BP(每臂201例--干预与常规护理相比；50%为女性；50%为黑人)，并由Blue全面保险 路易斯安那州十字蓝盾。这项研究将有90%的统计能力来检测12岁时15%的差异 PDC≥为0.8%的参与者在随机接受干预的参与者与 常规护理和注意力控制。在第二个目标下，星图在性别和种族亚组中的有效性 将会被探索。这种方法是创新的，因为这将是第一次严格测试新的 BP，针对对药物的负面含蓄态度的干预，目的是提高依从性 控制力和生活质量。这项拟议的研究具有重要意义，因为它将代表着继续- 预计将导致有效、可扩展的干预措施的研究(具有关于基础数据的 行为改变机制)。最后，预计研究结果将为人们对被低估的 不坚持的心理机制(即内隐态度)，这可能有助于提高工作效率。 其他服药依从性干预措施的有效性。