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: 10209662
• 负责人: Marie Krousel-Wood
• 金额: $ 64.24万
• 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/10209662
• 关键词: Adherence; Adult; Antihypertensive Agents; Attention; 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; Intervention; Intervention Trial; Knowledge; Lead; Learning; Life; Louisiana; Mediation; Methods; Modeling; National Heart, Lung, and Blood Institute; Older Population; Outcome; Participant; 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; Telephone; Testing; United States National Institutes of Health; Woman; Work; adherence rate; attentional control; base; behavior change; behavioral adherence; blood pressure medication; blood pressure reduction; blood pressure regulation; burden of illness; cardiovascular disorder risk; cardiovascular health; design; disability; evidence base; healthy aging; high risk; improved; innovation; insight; intervention program; medication compliance; medication nonadherence; men; novel; novel strategies; older men; older women; primary outcome; programs; psychologic; randomized trial; sex; tool; treatment arm; treatment as usual

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.

项目摘要 在干预措施的可获得性方面存在根本差距，1）可持续地改善对预先治疗的坚持， 记录血压（BP）药物，2）确定潜在的行为改变机制，3）恶魔- 在老年人中按性别和种族显示疗效。因此，改善依从性和血压控制的干预措施 保持最低限度的有效性。长期目标是改善药物依从性、血压控制和健康 老年高血压患者的衰老。本R 01申请的总体目标是确定 支持量身定制的适应性变化和加强药物依从性计划（星星- MAP），它整合了变革性的克服对变化的免疫力（OITC）健康指导过程， 改善依从性、血压控制和生活质量（QOL）。该办公室的做法已证明在以下方面是有用的： 在研究小组最近的试点研究中，其他领域已成功应用于BP管理。基于 这项先前的工作，中心假设是，STAR-MAP，旨在帮助非粘附性老年高血压， 成年人识别和改变阻碍药物依从性的内隐态度，将改变心态和即时通讯。 证明每天服用处方药，导致血压降低和生活质量改善。亲的理由， 提出的研究是，证明STAR-MAP的疗效将提供新的机会，推翻 不遵守行为和改善血压控制和健康老龄化的老年人不断增长的人口与 高血压，总体以及性别和种族亚组。中心假设将通过以下两个方面进行检验： 具体目标：（1）确定STAR-MAP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局的研究;以及（2） 探索STAR-MAP在性别和种族亚组中的有效性。在第一个目标下， 试验将在402名年龄≥65岁的非依从性（覆盖天数比例（PDC）<0.8）成人中进行， 控制血压（每组201-干预与常规护理; 50%女性; 50%黑人），并由Blue全额保险 路易斯安那州的蓝盾。该研究将有90%的统计把握度在12时检测到15%的差异 随机分配至干预组的受试者与 注意力控制的常规护理。在第二个目标下，STAR-MAP在性别和种族亚组中的疗效 将被探索。这种方法是创新的，因为它将是第一个严格测试一种新的 针对药物的负面内隐态度进行干预，目的是提高依从性，BP 控制和QOL。拟议的研究是重要的，因为它将代表一个连续的重要一步， 预计将导致有效、可扩展干预的研究（具有基础数据） 行为改变机制）。最后，研究结果有望为一个被低估的问题提供新的见解。 心理机制（即，不遵守的内隐态度），这可能有助于改善效果- 其他药物依从性干预措施。