Smartphone Medication Adherence Stops Hypertension (SMASH) Among Hispanics

描述（由申请人提供）：未控制的原发性高血压（EH）是卒中、肾衰竭和心血管事件的主要危险因素。西班牙裔的比例最高， 在美国，不受控制的EH（BPE 140/90 mmHg）。两个主要原因是患者药物治疗不依从和临床医生未能及时加强治疗（即，治疗惰性）。BP控制计划是必要的，可以持续的环境卫生和容易传播的医疗保健提供者。目前还没有随机对照试验（RCT）评估理论驱动的文化定制的移动的健康技术应用于西班牙裔未受控制的高血压患者。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包括多层次组件：1）来自电子药物托盘的自动提醒; 2）基于每日药物和BP监测的依从性定制的短信/语音邮件激励反馈和强化; 3）自动总结报告和向提供者的直接警报;以及4）针对3个月试验后BP控制和/或药物依从性恶化的SMASH患者的强化计划。其目标如下：目标1a：在60例未控制的21-55岁西班牙裔EH患者中进行为期3个月的2组（SMASH vs.增强标准治疗[SC]）可行性RCT，随访6个月。主要可行性结局是招募和保留率、干预使用以及患者和提供者满意度的测量，目标1b：获得血压变化主要结局变化的变异性估计值（即达到JN 7指定血压控制的百分比：静息血压<140/90 mmHg）。其他血压测量包括：达到24小时血压控制的百分比：< 130/80 mmHg）以及在3、6和9个月时静息和24小时血压的绝对降低。次要结局：患者依从性（药物摄入，BP自我监测），自我效能和内在动机的自我决定理论结构（即，自主监管）和供应商遵守JNC 7指南（医疗变更的时间）。目标2.在6个月的最终随访后，与提供者和工作人员（n=6-10）以及随机抽样的SMASH人员（n=16）进行焦点小组讨论，以评估关键用户反应，包括感知的文化敏感性、可接受性、可用性、突出性和可持续性促进因素/障碍。目标3.对来自目标1和2的数据进行三角分析，以进一步完善和优化SMASH，并为全面疗效/有效性RCT做准备（PA-12-022，R 01）。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。SMASH在不同民族/种族群体中的传播将有助于减轻心血管疾病的负担和相关的健康差异。

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.