Nighttime Dosing of Anti-Hypertensive Medications: A Pragmatic Clinical Trial

夜间服用抗高血压药物：一项实用的临床试验

• 批准号: 8465693
• 负责人: GARY E ROSENTHAL
• 金额: $ 77.01万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-30 至 2013-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8465693
• 关键词: Accident and Emergency department; Acute myocardial infarction; Admission activity; Adverse effects; Affect; Algorithms; American; Antihypertensive Agents; Area; Biological; Blood Pressure; Cardiovascular Diseases; Cardiovascular system; Cerebrum; Cessation of life; Chronic Kidney Failure; Clinic; Clinical; Clinical Trials; Computerized Medical Record; Congestive Heart Failure; Coronary; Data; Data Collection; Diabetes Mellitus; Disease; Dose; Effectiveness; Eligibility Determination; Enrollment; Evaluation; Event; Funding; Goals; Health; Health system; Healthcare Systems; Heart failure; Hospitals; Hour; Hypertension; Informed Consent; Integrated Health Care Systems; Intervention; Kidney Failure; Lead; Methods; Multi-Institutional Clinical Trial; Myocardial Infarction; Myocardial Ischemia; Online Systems; Outpatients; Patient Outcomes Assessments; Patient Recruitments; Patient Self-Report; Patients; Peripheral; Peripheral Vascular Diseases; Personal Health Records; Pharmaceutical Preparations; Phase; Population; Prevalence; Procedures; Process; Randomized; Reporting; Research; Research Personnel; Risk; Risk Factors; Site; Sleep; Specific qualifier value; Stroke; Symptoms; Telephone; Testing; Time; Treatment Efficacy; United States National Institutes of Health; Visit; Work; artery occlusion; base; cardiovascular disorder risk; cardiovascular risk factor; collaboratory; compliance behavior; follow-up; hazard; health care service utilization; health related quality of life; improved; innovation; medication compliance; meetings; multi-site trial; novel; pragmatic trial; primary care setting; systems research; trial comparing; web site

DESCRIPTION (provided by applicant): Two recent small clinical trials reported that hypertensive patients with chronic kidney disease or diabetes who were assigned to take at least one antihypertensive at bedtime had a dramatically lower risk of cardiovascular events. The simplicity of the intervention (changing the timing of medication administration), the prevalence of the underlying condition, and the large potential impact of the intervention on improving health make this area an ideal topic for a pragmatic clinical trial. Thus, the proposed trial will determine the effectiveness of nighttime dosing of antihypertensive medications in patients at risk of adverse cardiovascular events. The study will be conducted at two integrated health systems and will build on the innovative work of the investigative team in: 1) developing electronic medical record (EMR) based patient recruitment strategies; 2) building interactive web-based platforms for obtaining informed consent; 3) extracting research data from EMRs; 4) collecting patient-reported outcomes web-based personal health records; and 5) conducting NIH and VA funded multi-site trials in routine primary care settings to improve management of hypertension. During the UH2 component, the investigators will refine and then implement a number of innovative and highly efficient strategies for patient recruitment, data collection, and obtaining informed consent at the two participating sites. During the UH3 component, the team will conduct randomized pragmatic trial to examine the impact of nighttime antihypertensive dosing. The study will enroll an estimated 1100 patients from the two sites during a seven-month period. Patients will be followed for the subsequent 36-42 months to determine the occurrence of major cardiovascular events. Other study endpoints include clinic and sleep time blood pressure, medication adherence, health related quality of life, symptoms, and healthcare utilization. Eligible patients will be identified using EMR-based algorithms. Informed consent will be obtained using an interactive web-based platform or a 1-800 telephone contact with a study coordinator. Study data will be extracted from EMRs at the two participating sites and from web-based personal health records. PUBLIC HEALTH RELEVANCE: This study will involve conducting a simple and practical clinical trial to determine if taking medication for high blood pressure at night, as opposed to in the morning, lead to a lower risk of cardiovascular disease in patients with hypertension. The study will collect data from electronic medical records and from personal health records and will use an innovative website to collect informed consent from patients.

描述（由申请人提供）：最近两项小型临床试验报道，在睡前服用至少一种降压药的高血压合并慢性肾脏疾病或糖尿病患者发生心血管事件的风险显著降低。干预的简单性（改变给药时间）、潜在疾病的普遍性以及干预对改善健康的巨大潜在影响使该领域成为实用临床试验的理想主题。因此，拟议的试验将确定夜间给药抗高血压药物对有不良心血管事件风险的患者的有效性。该研究将在两个综合卫生系统中进行，并将以调查团队的创新工作为基础：1)制定基于电子病历（EMR）的患者招募策略；2)构建基于网络的交互式知情同意获取平台；3)从电子病历中提取研究数据；4)收集基于网络的患者报告结果的个人健康记录；5)在常规初级保健环境中开展NIH和VA资助的多地点试验，以改善高血压的管理。在UH2部分，研究人员将完善并实施一些创新和高效的策略，以在两个参与站点进行患者招募、数据收集和获得知情同意。在UH3组成部分，该团队将进行随机实用试验，以检查夜间抗高血压剂量的影响。该研究将在7个月的时间内从两个地点招募约1100名患者。随访患者36-42个月，以确定主要心血管事件的发生。其他研究终点包括临床和睡眠时间、血压、药物依从性、健康相关的生活质量、症状和医疗保健利用。符合条件的患者将使用基于电子病历的算法进行识别。知情同意将通过交互式网络平台或1-800电话联系研究协调员获得。研究数据将从两个参与站点的电子病历和基于网络的个人健康记录中提取。