Smartphone Medication Adherence Stops Hypertension (SMASH) Among Hispanics

坚持使用智能手机药物可阻止西班牙裔高血压 (SMASH)

• 批准号: 8702567
• 负责人: Frank A Treiber
• 金额: $ 22.43万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-03-15 至 2016-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8702567
• 关键词: Address; Adherence; Affect; Auditory; Behavior; Belief; Blinking; Blood Pressure; Blood Pressure Monitors; Cardiovascular Diseases; Cardiovascular system; Caring; Case Manager; Cells; Cellular Phone; Chronic Disease; Data; Deterioration; Development; Diabetes Mellitus; Disease Management; Effectiveness; Effectiveness of Interventions; Electronics; Essential Hypertension; Event; Face; Failure; Feedback; Focus Groups; Guidelines; Health; Health Personnel; Health Technology; Healthcare; His-His-His-His-His-His; Hispanics; Hour; Hypertension; Insurance; Intake; Intervention; Kidney Diseases; Kidney Failure; Language; Light; Mails; Measures; Medical; Minority Groups; Motivation; Not Hispanic or Latino; Office Nursing; Outcome; Outcome Measure; Panic; Partner in relationship; Patient Self-Report; Patients; Pear; Pharmaceutical Preparations; Prevention program; Primary Health Care; Primary Prevention; Provider; Psychological reinforcement; Race; Randomized; Randomized Controlled Trials; Reaction; Regimen; Regulation; Research; Research Proposals; Rest; Risk Factors; Sampling; Secondary Prevention; Self Blood Pressure Monitoring; Self Determination; Self Efficacy; Self Management; Signal Transduction; Stroke; Summary Reports; Telephone; Testing; Text; Therapeutic; Time; Voice; arm; base; blood pressure regulation; compliance behavior; cultural values; design; ethnic minority population; follow-up; health disparity; high risk; improved; indexing; mHealth; medication compliance; novel; primary care setting; primary outcome; programs; public health relevance; racial and ethnic disparities; response; satisfaction; secondary outcome; standard care; theories; usability

DESCRIPTION (provided by applicant): Uncontrolled essential hypertension (EH) is a major risk factor for stroke, renal failure and cardiovascular events. Hispanics have the highest rate of uncontrolled EH (BP e 140/90 mmHg) in the U.S. Two primary responsible factors are patient medication non-adherence and clinician failure to intensify therapy in timely manners (i.e., therapeutic inertia). BP control programs are needed which can be sustained by EHs and readily disseminated by healthcare providers. There have been no randomized controlled trials (RCTs) evaluating theory driven culturally tailored mobile health technology applications among Hispanics with uncontrolled EH. In response to PA-12-023, the proposed R21 research proposal will test and refine the Smart phone Medication Adherence Stops Hypertension (SMASH) program. SMASH includes multi-level components: 1) automated reminders from an electronic medication tray; 2) tailored text message/voice mail motivational feedback and reinforcement based upon adherence to daily medication and BP monitoring; 3) automated summary reports and direct alerts to providers and 4) booster program for SMASHers who show deterioration in BP control and/or medication adherence after the 3 month trial. The aims are as follows: Aim 1a: Conduct 3 month 2 arm (SMASH vs. enhanced Standard Care [SC]) feasibility RCT with 6 month follow up in 60 uncontrolled EH 21-55 year old Hispanics. Primary feasibility outcomes are measures of recruitment and retention rates, intervention use and patient and provider satisfaction, and Aim 1b: Obtain estimates of variability of changes in primary outcomes of BP changes (i.e. % reaching JN7 designated BP control: resting BP <140/90 mmHg). Other BP measures include: % reaching 24-hour BP control: < 130/80 mmHg) and absolute reductions in resting and 24-hour BP at 3, 6, and 9 months. Secondary outcomes: patient adherence (med intake, BP self-monitoring), self-determination theory constructs of self-efficacy and intrinsic motivation (i.e., autonomous regulation) and provider adherence to JNC7 guidelines (timing of med changes). Aim 2. Conduct focus groups after 6 month final follow-up with providers and staff (n=6-10) and random sample of SMASHers (n=16) to assess key user reactions including perceived cultural sensitivity, acceptability, usability, salience & sustainability facilitators/barriers. Aim 3. Triangulate data from Aims 1 and 2 to further refine and optimize SMASH and prepare for a full-scale efficacy/effectiveness RCT (PA-12-022, R01). Long-term objective is to develop practical, effective and sustainable mHealth primary and secondary prevention programs for EH and CVD. Dissemination of SMASH across ethnic/racial groups will help ameliorate the burden of CVD and associated health disparities.

描述(由申请人提供)：未控制的原发性高血压(EH)是中风、肾功能衰竭和心血管事件的主要危险因素。拉美裔美国人的比例最高 两个主要的责任因素是患者用药不坚持和临床医生未能及时加强治疗(即治疗惰性)。BP控制程序是需要的，它可以由EHS维持，并易于由医疗保健提供者传播。还没有随机对照试验(RCT)评估理论驱动的、在患有未受控制的EH的西班牙裔美国人中定制的移动医疗技术应用。作为对PA-12-023的回应，拟议的R21研究提案将测试和完善智能手机药物依从性阻止高血压(SMASH)计划。SMASH包括多个层次的组件：1)电子药物托盘上的自动提醒；2)基于遵守日常用药和血压监测的量身定制的短信/语音邮件激励反馈和强化；3)自动总结报告和对供应商的直接警报；4)为在3个月试验后血压控制和/或用药依从性恶化的粉碎者提供助推计划。目标如下：目标1a：对60名未控制的21-55岁拉美裔EH患者进行为期3个月、2个月的ARM(SMASH与增强型标准护理[SC])可行性随机对照试验，随访6个月。主要可行性成果是招募和保留率、干预使用以及患者和提供者满意度的衡量标准，目标1b：获得血压变化主要结果变化的估计(即达到JN7指定的BP控制的百分比：静息BP和Lt；140/90毫米汞柱)。其他降压措施包括：在3、6和9个月达到24小时血压控制的百分比)和绝对减少静息和24小时血压。次要结果：患者依从性(药物摄入量，血压自我监测)，自我决定理论对自我效能和内在动机的构建(即，自主调节)，以及提供者遵守JNC7指南(药物改变的时机)。目标2.在对提供者和工作人员(n=6-10)和粉碎者(n=16)随机抽样(n=16)进行6个月的最后跟踪后，进行重点小组，以评估关键用户的反应，包括感知的文化敏感性、可接受性、可用性、显著程度和可持续性促进因素/障碍。目的3.对目标1和目标2的数据进行三角测量，以进一步提炼和优化SMASH，并为全面的疗效/有效性随机对照试验做准备(PA-12-022，R01)。长期目标是为EH和CVD制定实用、有效和可持续的mHealth一级和二级预防计划。在族裔/种族群体中传播SMASH将有助于减轻心血管疾病的负担和相关的健康差距。