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临床试验/NCT00133068
NCT00133068已完成4 期

Collaboration to Reduce Disparities in Hypertension

University of Pennsylvania6 个研究点 分布在 1 个国家目标入组 802 人开始时间: 2005年3月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
802
试验地点
6
主要终点
Blood pressure

研究概览

简要总结

A large number of African-American and low socioeconomic patients have poorly controlled high blood pressure because of not being able to take their high blood pressure medications. This puts these patients at higher risk of heart and kidney disease, stroke and death. This study is designed to reduce the barriers that prevent patients from taking their high blood pressure medications.

详细描述

The objective of this study is to determine the effectiveness and cost-effectiveness of two interventions aimed at reducing barriers to blood pressure (BP) control in an indigent and African-American population. Specifically, we will conduct a randomized controlled trial comparing BP control using either: (1) reimbursing patients for filling prescriptions (reimbursement arm); (2) a computer-based behavioral intervention (behavioral arm); (3) both the reimbursement and behavioral arms (combined arms); or (4) neither.

The ultimate goal of this study is to reduce the incidence of HTN-related CVD among these populations thereby reducing cardiovascular health disparities. Specific aims of the study are to:

  1. test whether receiving money each time the patient fills a prescription for medications improves BP control by a clinically significant amount.

H1: Reimbursing patients for filling prescriptions will significantly improve BP control. 2. test whether a computer-based behavioral intervention improves BP control by a clinically significant amount.

H2: A computer-based behavioral intervention will significantly improve BP control. 3. test whether the two interventions are more effective in improving BP control than either alone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
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

  • Patients of the Philadelphia Veterans Administration Hospital Primary Care Clinic, PinnacleHealth Adult Outpatient Clinics and the VA Pittsburgh Healthcare System who have a diagnosis of hypertension; are currently taking antihypertensive medications; and have elevated blood pressure.

排除标准

  • Under 21 years of age
  • Have a diagnosis of:
  • Atrial fibrillation;
  • Metastatic cancer;
  • End stage renal disease (ESRD) with dialysis;
  • Dementia;
  • New York Heart Association (NYHA) class IV congestive heart failure (CHF);
  • Blind or deaf;
  • Other reason for life expectancy of less than 1 year.
  • Are currently participating in another experimental study

结局指标

主要结局

Blood pressure

时间窗: 6 months

次要结局

  • Cost(12 months)
  • Blood pressure(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen E. Kimmel

Stephen E. Kimmel, M.D., M.S.C.E,

University of Pennsylvania

研究点 (6)

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