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: 10470340
• 负责人: CAROLYN Harmon Still
• 金额: $ 69.79万
• 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/10470340
• 关键词: Adherence; Adult; African American population; Age; American; Antihypertensive Agents; Behavior; Behavior Therapy; Behavioral; Blood Pressure; Car Phone; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Chronic; Chronic Disease; Chronic Kidney Failure; Clinical; Counseling; Data; Diastolic blood pressure; Education; Elderly; Evidence based practice; Future; Gender; Goals; Guidelines; Health; Health Technology; Heart failure; High Density Lipoprotein Cholesterol; Hypertension; Individual; Intervention; Knowledge; Lead; Life; Lipids; Literature; Long-Term Effects; Mediating; Medication Management; Morbidity - disease rate; Myocardial Infarction; Nurses; Online Systems; Outcome; Patients; Pharmaceutical Preparations; Prevalence; Primary Health Care; Public Health; Qualitative Evaluations; Quality of life; Randomized Controlled Trials; Reporting; Research; Sampling; Science; Self Efficacy; Self Management; Serum; Social support; Stroke; Technology; Testing; Text; Time; Treatment Protocols; Waiting Lists; base; blood pressure control; blood pressure reduction; cardiovascular risk factor; clinical investigation; clinically relevant; community setting; comparison intervention; diet and exercise; 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; 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.

项目概要 高血压差异仍然存在，并且在非裔美国人 (AA) 中尤为严重。次优高血压 自我管理，包括坚持服用抗高血压药物仍然是一个重要的公共卫生问题 忧虑。据估计，43-78% 的患者对抗高血压药物的依从性较差，其中 大约 50% 的人在一年后停药，AA 中情况更糟。更令人担忧的是，AA 老年人可能不会 制定已知对 AA 人群更有效的循证实践治疗方案。那里 迫切需要可行的行为方法和长期自我管理策略， 可复制、可扩展。移动健康 (mHealth) 技术（手机应用程序 [app]、文本、视频 消息传递）是促进行为改变和维持自我管理的有前途的工具。 虽然越来越多的报告支持使用移动医疗技术来管理慢性病， 针对 AA 老年人的数据有限。文献中发现的有关移动医疗的其他差距 技术包括缺乏理论驱动，临床/流行病学调查主要是 在美国境外进行的研究限制了普遍性，并且缺乏长期可持续性的证据 对临床相关健康结果的影响。此R01应用，优化技术改进 药物依从性和血压控制 (OPTIMA-BP) 正在测试基于技术的干预措施 前瞻性随机对照试验 (RCT) 设计中的等待对照 (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，以使用理论驱动的方法 mHealth 药物管理应用程序与指南指导的治疗方案和护士相结合 咨询。 本研究的目的是： [1] 测试 OPTIMA-BP 与 WL 对收缩压和血清高血压的影响 前瞻性随机对照试验形式对患有高血压的 AA 老年人的密度脂蛋白胆固醇 (HDL) 进行评估；和[2] 测试自我管理的态度/知识机制（高血压知识、自我效能、 感知的社会支持）和近端行为目标机制（服用药物降低收缩压， 饮食、锻炼）介导 OPTIMA-BP 与 WL 对主要和次要结果（收缩压、 舒张压、健康相关生活质量、血脂以及至少 62% 的样本血压 <130/80 mmHg） 超过 12 个月的时间段。本研究的第二个目的是评估 OPTIMA-BP 和 WL 对 主要和次要结果，同时控制协变量/背景变量，例如年龄和性别。 该提案的一个补充和补充特征是定性评估，以确认自我 管理障碍和干预措施的感知优势或局限性，这将为未来提供信息 如果这些 RCT 结果是积极的，则需要进行改进。