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)：最近的两项小型临床试验报告称，患有慢性肾脏疾病或糖尿病的高血压患者在睡前被分配至少服用一种抗高血压药物，其心血管事件的风险显著降低。干预的简单性(改变给药的时间)，潜在疾病的流行，以及干预对改善健康的巨大潜在影响，使这一领域成为务实临床试验的理想主题。因此，这项拟议的试验将确定夜间服用降压药对有不良心血管事件风险的患者的有效性。这项研究将在两个集成的医疗系统中进行，并将以调查团队在以下方面的创新工作为基础：1)开发基于电子病历(EMR)的患者招募战略；2)建立获取知情同意的网络互动平台；3)从EMR提取研究数据；4)收集患者报告的结果；4)基于网络的个人健康记录；以及5)在常规初级保健环境中进行NIH和VA资助的多点试验，以改善高血压的管理。在UH2部分，调查人员将完善并实施一系列创新和高效的战略，以招募患者、收集数据，并在两个参与地点获得知情同意。在UH3部分，研究小组将进行随机、务实的试验，以检查夜间降压药剂量的影响。这项研究将在七个月的时间里从这两个地点招募约1100名患者。患者将在随后的36-42个月内接受跟踪，以确定主要心血管事件的发生情况。其他研究终点包括临床和睡眠时间、血压、服药依从性、与健康相关的生活质量、症状和医疗保健利用率。符合条件的患者将使用基于电子病历的算法进行识别。知情同意将使用基于网络的互动平台或与研究协调员的1-800电话联系获得。研究数据将从两个参与地点的急救人员和基于网络的个人健康记录中提取。 公共卫生相关性：这项研究将进行一项简单而实用的临床试验，以确定是否在夜间服用高血压药物，而不是在夜间服用药物。 早晨，高血压患者患心血管疾病的风险较低。这项研究将从电子病历和个人健康记录中收集数据，并将使用一个创新的网站来收集患者的知情同意。