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: 10396114
• 负责人: Marie Krousel-Wood
• 金额: $ 72.43万
• 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/10396114
• 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 control; blood pressure medication; blood pressure reduction; burden of illness; cardiovascular disorder risk; cardiovascular health; design; disability; 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; 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 干预措施的可用性存在根本的差距，1）可持续提高遵守 签名血压（BP）药物，2）识别潜在的行为改变机制，3）恶魔 - 老年人的性和种族策略效率。彼此之间，改善依从性和BP控制的干预措施 保持最低效率。长期目标是改善药物依从性，BP控制和健康 老年高血压成年人衰老。该R01应用的总体目标是确定 支持量身定制的自适应变化和药物依从性计划的加强（Star-- 地图），整合了变革性克服的免疫力变化（OITC）健康教练过程 关于改善依从性，BP控制和生活质量（QOL）。被证明对的OITC方法 在研究团队最近的试点研究中，其他领域已成功地应用于BP管理。基于 这项先前的工作是中心假设是旨在帮助非辅助老式高血压的星形图 成年人识别和改变隐性与会者，以阻碍药物依从性，将改变思维方式和影响 证明每天服用处方药，导致BP降低和质量提高质量。主张的理由 提出的研究是，表明星星映射的效率将为推翻提供新的机会 非戒备行为，改善BP控制和健康衰老 高血压，整体以及性别和种族亚组。中心假设将通过追求两个来检验 具体目的：（1）确定星形映射干预的效率，潜在机制和可持续性 旨在改善药物依从性和临床结果的旨在改善药物治疗行为； （2） 探索性别和种族亚组中星星图的效率。在第一个目标下，随机控制 试验将在402个非贴贴（覆盖天数的比例（PDC）<0.8）成年人≥65岁的成年人中进行 受控的BP（每只手臂201-干预与通常的护理； 50％的女性； 50％黑色），并完全由蓝色保险 路易斯安那州的十字架蓝盾。该研究将具有90％的统计能力，以检测12％的差异15％ 在随机进行干预的参与者中，PDC≥0.8的参与者比例的月份 通常的护理和注意力控制。在第二个目标下，星形图在性别和种族子组中的有效性 将被探索。这种方法具有创新性，因为它将是第一个严格测试新的大型临床试验 针对负面隐性参与者的干预措施，目的是提高依从性，BP 控制和QOL。拟议的研究很重要，因为它将代表继续的重要一步 预计会导致有效，可扩展的干预措施的研究（具有基础的数据 行为改变机制）。最后，预计结果将对未经充分的见解提供新的见解 不遵守的心理机制（即隐性出勤率）可能对提高效率有用 其他药物依从性干预措施的能力。