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临床试验/NCT00520988
NCT00520988已完成不适用

Improving Blood Pressure in Colorado

Kaiser Permanente3 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2006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
290
试验地点
3
主要终点
We will assess the primary measures of effectiveness (control of blood pressure) in the clinic at baseline and 6 months, for both the usual care plus IVR arm and usual care arm alone.

研究概览

简要总结

We will improve hypertension control in Colorado by implementing a population-based intervention using interactive voice response (IVR) technology that will be delivered to patients in three healthcare systems across Colorado (Denver Health and Hospitals [DH], VA Colorado Healthcare System [VA], and Kaiser Permanente of Colorado [KPCO]). Together, these organizations serve over 1 million Coloradans. The IVR-based hypertension program will: 1) reach out to more patients using fewer resources than a traditional patient visit approach, 2) implement evidence based guidelines for therapy, 3) facilitate patients' acquisition of medications by allowing them to order and receive medications at home, and 4) enhance medication adherence using tailored educational and motivational messages.

HYPOTHESES:

  1. A sizable population of patients is at high risk for further cardiovascular morbidity and mortality, based on uncontrolled hypertension.
  2. An IVR-centered intervention among patients with diagnosed but uncontrolled hypertension is feasible.
  3. An IVR-centered intervention plus usual care for these patients improves BP control, compared to usual care alone.

详细描述

Hypertension, or high blood pressure (BP), affects 65 million people or almost 1 out of every 4 adults in the U.S. Individuals who have normal BP at 55 years of age have a 90% lifetime risk for developing hypertension. The level of BP elevation is directly related to a person's subsequent risk for heart attack, heart failure, stroke, and kidney failure. In 2002, hypertension was the primary or contributing cause of death in 11% of US deaths and the cost of hypertension was estimated at $59.7 billion. The prevalence of sequelae of uncontrolled hypertension will increase as our population ages unless we develop better programs to control high BP. Hypertension is treatable. If you reduce a person's elevated BP, you reduce their risk of stroke by 30%, heart attack and others forms of coronary heart disease by 20%, congestive heart failure by 50%, and premature death by 10%.3 Despite the evidence supporting hypertension treatment, more than half of patients with hypertension have inadequate BP control.

We will improve hypertension control in Colorado by implementing a population-based intervention using interactive voice response (IVR) technology that will be delivered to patients in three healthcare systems across Colorado (Denver Health and Hospitals [DH], VA Colorado Healthcare System [VA], and Kaiser Permanente of Colorado [KPCO]). Together, these organizations serve over 1 million Coloradans. The IVR-based hypertension program will: 1) reach out to more patients using fewer resources than a traditional patient visit approach, 2) implement evidence based guidelines for therapy, 3) facilitate patients' acquisition of medications by allowing them to order and receive medications at home, and 4) enhance medication adherence using tailored educational and motivational messages. This program will not duplicate or supplant funding for existing programs, but will complement the existing programs which are based on traditional provider-patient encounters.

IVR is a computer-based telephone system that initiates outbound calls, receives inbound calls, and provides information and collects data from patients between office visits. An IVR system has three components: 1) a standard microcomputer, 2) hardware that interfaces with the telephone system to place calls, and 3) software that controls calling operations. Patients require only a telephone to participate in an IVR program. Over 95% of Coloradans have telephones. People are familiar with IVR applications such as systems used by airlines to provide flight information and by healthcare organizations to arrange clinic appointments and refill prescriptions.

*Detailed description of study procedures (duration, description of intervention, study measures, endpoints, specific aims, etc):

Study Visits (both study arms):

研究设计

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

入排标准

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

入选标准

  • 18 years of age or older
  • have diagnosed but uncontrolled hypertension
  • Most recent measurement and one other measurement of the 3 most recent blood pressure measurements in the past 2 years have a systolic pressure >140mmHg or a diastolic pressure >90mmHg. For patients with a diagnosis of diabetes or chronic kidney disease the blood pressure cut-offs will be systolic >130 mm Hg or a diastolic pressure > 80 mm Hg
  • not on organizational "do not call" lists or deceased lists
  • have been approved for invitation into the study by their physician
  • do not have a life-threatening illness
  • are not on more than 4 antihypertensive medications
  • can use a telephone
  • speak either English or Spanish

排除标准

  • on organizational "Do Not Call" list or deceased list
  • physician does not give permission for them to be included in the study
  • younger than 18 years of age
  • has a life-threatening illness
  • currently takes more than 4 anti-hypertension medications
  • does not have or cannot use a phone
  • does not speak English or Spanish (languages available in IVR)
  • does not want to participate

结局指标

主要结局

We will assess the primary measures of effectiveness (control of blood pressure) in the clinic at baseline and 6 months, for both the usual care plus IVR arm and usual care arm alone.

时间窗: 6 months of follow-up

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 (3)

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