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临床试验/NCT00781365
NCT00781365已完成不适用

Home Blood Pressure Telemonitoring and Case Management to Control Hypertension

HealthPartners Institute2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
450
试验地点
2
主要终点
Blood Pressure Control

研究概览

简要总结

In this project we develop and implement an intervention to improve hypertension control in a primary care setting that takes advantage of new technology (home blood pressure telemonitoring) and team models of care (pharmacist case management). The results of the project will have important implications for future efforts to improve care provided to many of the estimated 20 million Americans with uncontrolled hypertension.

详细描述

Blood pressure (BP) is controlled to recommended levels in only 1 in 3 people with hypertension, and there has been little improvement since the late 1980s, despite advances in evidence to support aggressive hypertension control, and availability of many new and effective antihypertensive drugs. It is clear that meaningful and sustained improvement in hypertension control will likely require fundamental changes in the current physician-centered office-visit based model of caring for hypertension. In this project we develop and implement an intervention that takes advantage of new technology and team models of care to improve BP measurement and control, solving the problems that have limited the application of case management approaches to hypertension care improvement. The study will take place in a diverse population of adults with hypertension cared for in a real-world primary care setting. The Telemonitoring Intervention (TI) integrates 2 innovative components: First, home BP measures are done using state-of-the-art modem-enabled automated equipment that internally stores and electronically transmits BP data through a simple touch-tone telephone connection to a secure web site. Second, a pharmacist case manager integrated with the primary care team through a jointly used electronic medical record (EMR) and formulary adjusts antihypertensive therapy using an approved written protocol, under a collaborative practice agreement with physicians. Treatment decisions are based on home BP data and are discussed and communicated to patients in telephone visits with the pharmacist case manager. Two-way communication between the pharmacist case manager and the patient's primary care team is assured by using a shared EMR and by additional secure messaging of the results of every pharmacist encounter to the primary care team. To assess the impact of the TI on hypertension control, patient satisfaction, and costs of care, we will conduct a cluster-randomized trial, assigning 16 primary care clinics and 450 of their nested patients with uncontrolled hypertension to either a Usual Care (UC) control group or TI. Blood pressure outcomes in both groups will be determined at baseline, 6, 12, 18 and 54 months in an identical and blinded fashion in a research clinic separate from the clinical setting where patients received their medical care. We hypothesize that guideline BP control will be achieved at 6 months and maintained at 12 months in more than 60% of patients from TI clinics, compared to < 40% in patients from UC clinics. We will compare satisfaction with care and costs in the TI and UC groups. The TI has the potential to improve hypertension control for millions of patients, and could be implemented widely in diverse and large patient populations based on performance in this randomized trial. The results of the project will have important implications for future efforts to improve care provided to many of the estimated 20 million Americans with uncontrolled hypertension.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21 years or more
  • Linked using EMR data to a HealthPartners Medical Group primary care clinic
  • Within the 12-month period of time prior to screening have had at least 2 primary care outpatient encounters, in the two most recent of which the blood pressure was above Joint National Committee 7 (JNC7) goal (<140/90 mmHg or <130/80 for patients with diabetes or kidney disease).
  • Have a measured blood pressure at a research clinic screening visit above the JNC7 goal

排除标准

  • Acute coronary syndrome or stroke within the past 3 months
  • Class III (marked limitation of physical activity) or IV (symptoms at rest) New York Heart Association heart failure, or known left ventricular ejection fraction (<30%)
  • Severe renal dysfunction, with epidermal growth factor receptor (eGFR) ,30 ml/min/1.73 m2 using the abbreviated Modification of Diet in Renal Disease Study (MDRD) equation
  • Known secondary causes of hypertension such as coarctation of the aorta, pheochromocytoma, adrenal cortical hypertension or renal vascular hypertension
  • Unwillingness to be followed for a period of 18 months
  • Pregnancy or unwillingness to use reliable bith control for females of child-bearing age
  • Participation in another clinical trial
  • Requires an interpreter to communicate with health care providers
  • Dementia, mental illness or any condition that would limit ability to give informed consent

结局指标

主要结局

Blood Pressure Control

时间窗: Baseline, 6 months, 12 months, 18 months

Percentage of patients with controlled blood pressure at each time point (less than 140/90 mmHg or 130/80 mmHg for patients with kidney disease or diabetes)

Mean Systolic Blood Pressure

时间窗: Baseline, 6 months, 12 months, 18 months, 54 months

Systolic blood pressure at baseline and 4 time points

Mean Diastolic Blood Pressure

时间窗: Baseline, 6 months, 12 months, 18 months, 54 months

Mean diastolic blood pressure at baseline and 4 time points

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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