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临床试验/NCT00127751
NCT00127751已完成2 期

A Cardiovascular Disease Multifactor Risk Reduction Program for Medically Underserved High-Risk Patients

Stanford University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2000年5月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
150
试验地点
2
主要终点
Cardiovascular disease risk score

研究概览

简要总结

The primary objective of this study was to evaluate the effectiveness of a multifactor cardiovascular disease (CVD) risk reduction program using team case management in high risk patients who have low family incomes and limited access to medical care. Patients were randomized to case management (99) or usual care (49) with baseline, 6-month and 12-month evaluations of CVD risk factors, clinical status and quality of life.

详细描述

The primary objective of this study was to evaluate the effectiveness of a multifactor cardiovascular disease (CVD) risk reduction program using team case management in high risk patients who have low family incomes and limited access to medical care. Patients were randomized to case management (99) or usual care (49) with baseline, 6-month and 12-month evaluations of CVD risk factors, clinical status and quality of life. Subjects were primarily recruited from patients being seen in free medical clinics in Santa Clara County California. Primary eligibility was ≥ 35 years of age, one or more CVD risk factors (with or without clinical CVD), low family income, and residing in Santa Clara County. Patients in the case management group were provided counseling services by specially trained registered nurses (RNs) and registered dieticians (RDs) and assisted in obtaining medications and medical services from programs provided in the county or indigent drug programs provided by selected pharmaceutical companies. Protocol driven treatment algorithms based on national practice guidelines were used and use of existing programs and resources were maximized. On average patients in case management were seen by staff 6-9 in the 12 months.

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
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women ≥ 35 years
  • One or more major risk factors
  • Live in Santa Clara County
  • Low family income that limits access to medical care

排除标准

  • Under active medical treatment for cancer, CVD or other major medical disorder
  • Reasonable access to health care
  • Under 35 years of age
  • Not a resident of Santa Clara County

结局指标

主要结局

Cardiovascular disease risk score

Low-density lipoprotein (LDL)-cholesterol

Systolic blood pressure

次要结局

  • Body mass index (BMI)
  • Physical activity score
  • Nutrition score

研究者

申办方类型
Other

研究点 (2)

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