Web-based, Patient-centered Approach to CVD Risk-factor Management and Reduction
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
- 否
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
Jeffrey Henderson, MD, MPH
President & CEO
Black Hills Center for American Indian Health
