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临床试验/NCT00105716
NCT00105716已完成不适用

Study to Lower Veterans Blood Pressure: Patient/Physician Intervention

US Department of Veterans Affairs2 个研究点 分布在 1 个国家目标入组 544 人开始时间: 2002年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
544
试验地点
2
主要终点
BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period.

研究概览

简要总结

This four and a half year trial is evaluating both a patient and a provider intervention in a primary care setting among diagnosed hypertensive veterans. The two primary hypotheses are: 1) the proportion of veterans with BP control who receive either the provider-directed decision support or the patient health education and behavioral intervention will be increased by 10% as compared to usual care; and 2) the proportion of veterans with BP control who receive both the provider-directed decision support and the patient health education and behavioral intervention will be increased by 25% as compared to usual care.

详细描述

Background:

There are 65 million Americans and over 8.5 million veterans who have been diagnosed with hypertension, yet only 31% have their blood pressure (BP) under effective control. Uncontrolled hypertension greatly increases the risk of stroke, CAD, renal failure, CHF, and mortality.

Objectives:

This four year study evaluated simultaneously both a patient and a provider intervention in a primary care setting among diagnosed hypertensive veterans. The two primary hypotheses were: 1) the proportion of veterans with BP control who receive either the provider-directed decision support or the patient behavioral/education intervention will be increased by 10% as compared to usual care; and 2) the proportion of veterans with BP control who receive both the provider-directed decision support and the patient health education and behavioral intervention will be increased by 25% as compared to usual care.

Methods:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • >1 ICD9 Diagnosis 401.0, 401.1, 401.9
  • Designated Primary Care Provider
  • >1 Primary Care visit between 1/01/01-12/31/01
  • Restricted to NC and VA addresses
  • >1 Medication CV100, CV150, CV200, CV490, CV701, CV702, CV704, CV800, CV805

排除标准

  • Dialysis patient
  • Hospitalization for stroke in prior 3 months
  • Myocardial infarction in prior 3 months
  • Coronary artery revascularization in prior 3 months
  • Metastatic cancer diagnosis in prior 3 months
  • Transplant of: kidney; liver; lung; pancreas; peripheral stem cells; bone; bone marrow; heart; intestine; stem cells; tissue V42.9; complications of transplants
  • Nursing home resident
  • Documented diagnosis of dementia
  • Difficulty hearing

结局指标

主要结局

BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period.

次要结局

  • Knowledge and perceived risks associated with hypertension and ability to continue hypertension regimen will be assessed at baseline and via telephone 6 and 24 months after baseline; Medication adherence will be assessed from pharmacy records

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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