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)

基本信息

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
项目类别：
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

项目摘要

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）：不受控制的原发性高血压（EH）是中风、肾衰竭和心血管事件的主要危险因素。西班牙裔比例最高美国失控的 EH (BP e 140/90 mmHg) 两个主要因素是患者不遵守药物治疗和临床医生未能及时加强治疗（即治疗惰性）。需要血压控制计划，该计划可以由 EH 维持并由医疗保健提供者轻松传播。目前还没有随机对照试验 (RCT) 评估理论驱动的文化定制移动医疗技术在患有不受控制的 EH 的西班牙裔中的应用。为了响应 PA-12-023，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 包括多级组件：1) 来自电子药物托盘的自动提醒； 2) 根据日常用药和血压监测的坚持情况，定制短信/语音邮件激励反馈和强化； 3) 自动总结报告和直接向提供者发出警报，4) 针对 3 个月试验后血压控制和/或药物依从性恶化的 SMASHers 进行加强计划。目标如下：目标 1a：对 60 名不受控制的 EH 21-55 岁西班牙裔进行 3 个月 2 臂（SMASH 与增强标准护理 [SC]）可行性 RCT，并进行 6 个月随访。主要可行性结果是招募和保留率、干预措施使用以及患者和提供者满意度的衡量标准，以及目标 1b：获得血压变化主要结果变化的变异性估计（即达到 JN7 指定血压控制的百分比：静息血压 <140/90毫米汞柱）。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 3、6 和 9 个月时静息血压和 24 小时血压的绝对降低。次要结果：患者依从性（药物摄入量、血压自我监测）、自我效能和内在动机的自我决定理论构建（即自主调节）以及提供者对 JNC7 指南的依从性（药物变更的时机）。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 SMASHers 的随机样本 (n=16) 进行焦点小组，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、显着性和可持续性促进因素/障碍。目标 3. 对目标 1 和 2 的数据进行三角测量，以进一步细化和优化 SMASH，并为全面的功效/效果 RCT 做好准备（PA-12-022，R01）。长期目标是针对 EH 和 CVD 制定实用、有效和可持续的移动医疗一级和二级预防计划。在民族/种族群体中传播 SMASH 将有助于减轻 CVD 的负担和相关的健康差异。