OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP).

改善药物依从性和血压控制的优化技术 (OPTIMA-BP)。

• 批准号: 10611508
• 负责人: CAROLYN Harmon Still
• 金额: $ 68.42万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-13 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10611508
• 关键词: Adherence; Adult; African American population; Age; American; Antihypertensive Agents; Attitude; Behavior; Behavior Therapy; Behavioral; Blood Pressure; Cardiovascular Diseases; Cardiovascular system; Cellular Phone; Cessation of life; Chronic; Chronic Disease; Chronic Kidney Failure; Clinical; Counseling; Data; Diastolic blood pressure; Diet; Disparity; Education; Elderly; Evidence based practice; Exercise; Future; Gender; Goals; Guidelines; Health; Health Technology; Heart failure; High Density Lipoprotein Cholesterol; Hypertension; Individual; Intervention; Knowledge; Life; Lipids; Literature; Long-Term Effects; Mediating; Medication Management; Morbidity - disease rate; Myocardial Infarction; Nurses; Online Systems; Outcome; Patients; Pharmaceutical Preparations; Prevalence; Primary Care; Public Health; Qualitative Evaluations; Quality of life; Randomized, Controlled Trials; Recommendation; Reporting; Research; Sampling; Science; Self Efficacy; Self Management; Serum; Social support; Stroke; Technology; Testing; Text; Time; Treatment Protocols; Waiting Lists; blood pressure control; blood pressure reduction; cardiovascular risk factor; clinical investigation; clinically relevant; community setting; comparison intervention; effective therapy; epidemiology study; evidence base; evidence based guidelines; experience; follow-up; health related quality of life; hypertension control; hypertension treatment; hypertensive; improved; innovation; mHealth; mange; medication compliance; mortality; patient oriented; patient-clinician communication; primary outcome; prospective; racial disparity; response; secondary outcome; skills training; smartphone application; tool; trial design

PROJECT SUMMARY Hypertension disparities persist and are particularly worst in African Americans (AA). Suboptimal hypertension self-management, including adherence to medication-taking of antihypertensives remains a major public health concern. Poor adherence to antihypertensive medications is estimated to occur in 43-78% of patients, with approximately 50% discontinuation after a year, and worse in AA. Even more alarming, AA older adults may not be prescribe evidence-based practice treatment regimens known to more efficient in the AA population. There is a critical need for behavioral approaches and long-term self-management strategies that are feasible, replicable, and scalable. Mobile Health (mHealth) technologies (mobile phone applications [app], text, video messaging) are promising tools to facilitate behavioral change and sustain self-management. While reports support using mHealth technologies for the management of chronic diseases have grown, there is limited data specific to AA older adults. Other gaps identified in the literature regarding mHealth technology include the lack of being theoretically driven, the clinical/epidemiologic investigations are primarily conducted outside of the U.S. limiting generalizability, and the lack of evidence on long-term sustainability and impact on clinically relevant health outcomes. This R01 application, OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP) is testing a technology-based interventions compared to a wait-listed control (WL) in a prospective, randomized controlled trial (RCT) design. OPTIMA-BP includes evidenced-based strategies, web-based education, and behavioral skills training to use a theoretically driven mHealth medication management app in conjunction with a guideline directed treatment regimen and nurse counseling. The aims of this study are: [1] To test the effects of OPTIMA-BP vs. WL on systolic BP and serum high- density lipoprotein cholesterol (HDL) in AA older adults with hypertension in a prospective, RCT format; and [2] To test if the attitudinal/knowledge mechanisms of self-management (hypertension knowledge, self-efficacy, perceived social support) and proximal behavioral target mechanisms (taking medications to reduce systolic BP, diet, exercise) mediate OPTIMA-BP vs. WL’s impact on the primary and secondary outcomes (systolic BP, diastolic BP, health-related quality of life, serum lipids, and at least 62% of the sample with BP <130/80 mmHg) over a 12-month time period. A secondary aim of this study will assess OPTIMA-BP and WL’s impact on the primary and secondary outcomes while controlling for covariates/contextual variables such as age and gender. A supplemental and complementary feature of this proposal is the qualitative evaluation to confirm self- management barriers and perceived strengths or limitations of the intervention, which will inform future refinements should these RCT findings be positive.

项目摘要 高血压差异持续存在，在非洲裔美国人（AA）中尤为最差。次优高血压 自我管理，包括遵守降压药的服药仍然是主要的公共卫生 忧虑。据估计，对降压药的依从性较差，有43-78％的患者患有 一年后，中止大约50％，而在AA中则更糟。更令人震惊的是，老年人可能不会 被处方为基于证据的实践治疗方案，已知在AA人群中更有效。那里 是可行的行为方法和长期自我管理策略的迫切需求， 可复制且可扩展。移动健康（MHealth）Technologies（手机应用程序[应用]，文本，视频 消息传递）是促进行为改变并维持自我管理的工具。 尽管使用MHealth Technologies进行慢性疾病管理的报告支持已增长，但 AA老年人的数据有限。有关MHealth的文献中发现的其他差距 技术包括缺乏理论上的驱动，临床/流行病学研究是主要的 在美国以外进行的限制了普遍性，缺乏有关长期可持续性和 对临床相关的健康结果的影响。此R01应用程序，优化技术以改进 与药物依从性和BP控制（Optima-BP）相比，正在测试基于技术的干预措施 在前瞻性，随机对照试验（RCT）设计中的等待上市控制（WL）。 Optima-BP包括 基于证据的策略，基于网络的教育和行为技能培训，以使用理论驱动器 MHealth药物管理应用程序与指定的指导治疗方案和护士结合 咨询。 这项研究的目的是：[1]测试Optima-BP与WL对收缩BP和血清高的影响 AA老年人的密度脂蛋白胆固醇（HDL），具有预期的RCT格式的高血压；和[2] 测试自我管理的态度/知识机制（高血压知识，自我有效， 感知的社会支持）和近端行为目标机制（服用药物来减少收缩压， 饮食，运动）介导Optima-BP与WL对主要和次要结果的影响（收缩BP， 舒张压，健康相关的生活质量，血清脂质和至少62％的BP <130/80 mmHg） 在12个月的时间内。这项研究的次要目的将评估Optima-BP和WL对 在控制协变量/上下文变量（例如年龄和性别）时，主要和次要结果。 该提案的补充和完善功能是定性评估，以确认自我 管理障碍以及干预的优势或局限性，这将为未来提供信息 这些RCT发现应该是积极的。