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临床试验/NCT00608387
NCT00608387已完成不适用

Web-based, Patient-centered Approach to CVD Risk-factor Management and Reduction

Black Hills Center for American Indian Health2 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2009年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
149
试验地点
2
主要终点
Glycosylated hemoglobin (HbgA1c)

研究概览

简要总结

Cardiovascular disease (CVD) is a serious health concern for American Indians, but there have been few behaviorally based programs to lessen CVD risk among this population. The purpose of this study is to evaluate whether a Web-based program, in addition to usual medical care, can lower CVD risk factors among American Indians who have type 2 diabetes and a high risk of developing CVD.

详细描述

Cardiovascular disease (CVD) is a leading cause of death among American Indians. Significant risk factors for CVD within the American Indian population include type 2 diabetes, tobacco use, poor dietary and physical activity habits, and poor medication and treatment adherence. Despite the fact that these risk factors can be reduced through behavior change, there have been few behaviorally based interventions aimed at American Indians to lessen their CVD risk. Research has shown that medical care is moving away from sporadic, standard doctors' office visits to a more continuous and interactive relationship with health care providers. A Web-based program that allows people to interact with remotely located doctors who can answer questions and provide advice may be beneficial at increasing treatment adherence and lowering CVD risk. This study will evaluate the use of a Web-based program at lowering CVD risk among American Indians with type 2 diabetes. Researchers will also analyze the cost-effectiveness of the Web-based program and the possible healthcare cost savings.

This 3-year study will enroll American Indian adults at high risk for CVD. Participants will be randomly assigned either to usual care at their local health facility or usual care plus the Web-based program. Participants using the Web-based program will have access to a Web site that will allow them to interact with two remotely based doctors. Participants will be able to send e-mail and instant messages to ask questions and receive information, advice, or motivational messages from the doctors. Participants will periodically enter their blood glucose test results and complete questionnaires online. Study visits, occurring twice a year for 3 years, will include blood pressure and body mass index (BMI) measurements, blood collection, and smoking status assessments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Completed a baseline Education and Research Towards Health (EARTH) study examination
  • Diagnosed with type 2 diabetes mellitus AND hypertension and/or hyperlipidemia
  • Able to read and understand English
  • Able to walk

排除标准

  • Diagnosed with CVD at study entry
  • Currently receiving active treatment for any non-skin cell cancer
  • Any medical condition that study physicians believe would interfere with study participation or evaluation of results
  • Mental incapacity and/or cognitive impairment that would preclude adequate understanding of, or cooperation with, the study procedures
  • Kidney insufficiency, as indicated by serum creatinine level greater than 2.0 mg/dL for women and greater than 2.4 mg/dL for men

结局指标

主要结局

Glycosylated hemoglobin (HbgA1c)

时间窗: Measured at Year 3

次要结局

  • Mean blood pressure(Measured at Year 3)
  • Overall cost-effectiveness(Measured at Year 3)
  • Low-density lipoprotein cholesterol (LDL)(Measured at Year 3)
  • BMI(Measured at Year 3)
  • Smoking status(Measured at Year 3)

研究者

发起方
Black Hills Center for American Indian Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey Henderson, MD, MPH

President & CEO

Black Hills Center for American Indian Health

研究点 (2)

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