Patient Centered Health Technology Medication Adherence Program for African American Hypertensives

以患者为中心的非裔美国人高血压健康技术药物依从计划

基本信息

批准号：
9381307
负责人：
Frank A Treiber
金额：
$ 67.53万
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：
2017
资助国家：
美国
起止时间：
2017-07-10 至 2021-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9381307
关键词：
Accident and Emergency department Address Adherence Adult Adverse effects Affect African American Age Belief Biological Blinking Blood Glucose Blood Pressure Blood Pressure Monitors Cardiovascular Diseases Cardiovascular system Caring Case Manager Cellular Phone Cholesterol Chronic Disease Clinic Comorbidity Competence Data Development Diabetes Mellitus Diagnosis Education Effectiveness Ethnic group Evaluation Event Exhibits Feedback Feeling Focus Groups Future Gender Gifts Guidelines Health Personnel Health Technology High Prevalence Hour Hypertension Income Influentials Intervention Kidney Kidney Failure Life Light Low-Density Lipoproteins Measures Mediator of activation protein Medical Medicine Methods Monitor Morbidity - disease rate Motivation Myocardial Infarction Office Nursing Outcome Patient Self-Report Patients Pharmaceutical Preparations Phonation Plant Roots Premature Mortality Program Acceptability Provider Psychological reinforcement Questionnaires Randomized Randomized Controlled Trials Reaction Regimen Research Rest Risk Risk Factors Sampling Self Blood Pressure Monitoring Self Determination Self Efficacy Self Management Severity of illness Site Social Reinforcement Stroke Summary Reports Symptoms Technology Telephone Testing Text Therapeutic Time Voice Work active method arm base blood pressure regulation cohort cost effectiveness depressive symptoms early onset experience follow-up functional health literacy health disparity health literacy high risk population hypercholesterolemia improved indexing innovation mHealth medication compliance meetings novel patient oriented primary outcome programs racial and ethnic disparities satisfaction secondary outcome standard care standard of care success theories treatment duration usability

项目摘要

PROJECT ABSTRACT/SUMMARY Efforts to improve medication non-adherence (MNA) and blood pressure (BP) control in patients with hypertension (HTN) have met with limited success. Innovative approaches are needed that are acceptable, sustainable, efficacious, and easily disseminated. There have been no randomized controlled trials (RCTs) evaluating the application of theory-driven, patient centered, mobile health (mHealth) technology programs among African Americans (AAs) with MNA and uncontrolled HTN. The proposed research 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 guided by self-determination theory and based upon adherence to daily medication and BP monitoring and 3) automated summary reports and direct alerts to providers. A 6- month, 2-arm (SMASH vs. enhanced Standard Care [SC]) efficacy RCT will be conducted in 192 AAs (21-59 years old) with electronic monitor derived MNA and repeated clinic and 24hr BP verified uncontrolled HTN. Evaluations will occur at baseline, months 3 and 6, and post-trial follow-ups at months 12 and 18. Specific aims are to test the hypotheses that, compared to the enhanced SC cohort, the SMASH cohort will demonstrate significantly improved and sustained changes in: 1) Primary Outcome Variables: a) Medication adherence: % with electronic monitor-derived adherence scores >0.90;; b) BP control: % meeting JNC8 guidelines for BP control (resting BP <140/90 mmHg). 2) Secondary Outcome Variables: a) % reaching and sustaining 24-hr ambulatory BP<130/80 mmHg;; b) % of provider adherence to JNC8 guidelines as measured by timing of medication changes and c) patient changes in Self-Determination Theory constructs (e.g., competence and autonomous motivation). 3) Exploratory Outcomes: a) moderators (e.g., gender, age, income) and mediators (e.g., perceived severity of disease, med side effects, depression symptoms, etc.) of medication adherence and BP control;; b) cost effectiveness and c) physical risk factor changes (cholesterol, LDL, HgA1c, blood glucose). After final follow-up evaluations, focus groups with random sample of SMASH subjects (total n=32) and healthcare providers (total n=~12) will assess key user reactions including acceptability, usability, salience and aids/barriers to sustainability. Data from RCT and focus groups will be triangulated to further refine and optimize SMASH and prepare for a multi-site effectiveness RCT. Our long-term objective is to reduce premature mortality among AAs by developing effective and sustainable mHealth chronic disease medical regimen self-management programs including medication adherence, bio-function monitoring (e.g., BP) and timely bidirectional contact with healthcare providers.

项目摘要/总结改善药物不依从性 (MNA) 和血压 (BP) 控制的努力高血压（HTN）取得的成功有限。需要可接受的创新方法，可持续、有效且易于传播。尚无随机对照试验（RCT）。评估理论驱动、以患者为中心的移动健康 (mHealth) 技术项目的应用。拟议的研究将在患有 MNA 和不受控制的 HTN 的非裔美国人 (AA) 中进行测试和完善。智能手机药物坚持治疗高血压 (SMASH) 计划包括多级。组件：1) 来自电子药物托盘的自动提醒；2) 定制的短信/语音邮件以自决理论为指导并以坚持为基础的动机反馈和强化每日用药和血压监测以及 3) 自动总结报告和直接向提供者发出警报 A 6-。月，2 臂（SMASH 与增强型标准护理 [SC]）效率随机对照试验将在 192 个 AA（21-59 岁），并使用电子监测仪得出的 MNA 和重复临床以及 24 小时血压验证的不受控制的 HTN。评估将在基线、第 3 个月和第 6 个月进行，试验后随访将在第 12 个月和第 18 个月进行。具体目标是为了测试以下假设：与增强型 SC 队列相比，SMASH 队列将证明显着改善并持续变化： 1) 主要结果变量： a) 药物依从性：% 电子监测仪得出的依从性分数 >0.90；；b) 血压控制：% 符合 JNC8 血压指南控制（静息血压 <140/90 mmHg）2) 次要结果变量：a) 达到并维持 24 小时的百分比。动态血压<130/80 mmHg；；b) 遵守 JNC8 指南的百分比（通过时间测量）药物变化和 c) 患者自决理论结构的变化（例如，能力和 3) 探索性结果：a) 调节因素（例如性别、年龄、收入）和调解因素（例如，感知到的疾病严重程度、药物副作用、抑郁症状等）药物依从性血压控制；b) 成本效益和 c) 身体危险因素变化（胆固醇、LDL、HgA1c、血液）最终随访评估后，对 SMASH 受试者的随机样本进行焦点小组（总共 n=32）。医疗保健提供者（总共 n=~12）将评估关键用户反应，包括可接受性、可用性、显着性来自 RCT 和焦点小组的数据将进行三角测量，以进一步完善和解决。优化 SMASH 并为多站点有效性 RCT 做好准备我们的长期目标是减少。通过开发有效且可持续的移动健康慢性病医疗来降低AA的过早死亡率自我管理计划，包括药物依从性、生物功能监测（例如血压）和与医疗保健提供者及时双向联系。