Preventing Heart Disease in Underserved Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 465
- 试验地点
- 6
- 主要终点
- Framingham 10-year risk index
研究概览
简要总结
The study will evaluate the impact of an internet based telemedicine system on cardiovascular risk profile of underserved patient populations. It is our hypothesis that a treatment plan and frequent communication via an internet based Telemedicine system will improve the cardiovascular risk profile of underserved patient populations at increased risk for cardiovascular disease. Our primary endpoint is a reduction over one year in the 10-year CVD risk score (ATP III risk model).
详细描述
The Insight Telehealth system (ITSMyHealthfile) is a disease-managment interactive health care delivery system. Patients access the system through a special Web site using a password. The system prompts the patient to enter their weight, blood pressure and heart rate and there is a text box available for unstructed comments.
Patients will be randomized to either the telemedicine group or usual care group (controls). Individuals in the telemedicine group will be asked to transmit their health status weekly. Both groups will be followed for one year with quarterly visits.
Patients of either sex, of any ethnic background or race, between 22 and 85years of age, who have a 10% or greater 10-year risk of CVD based on the Framingham risk score, and risk factors that if properly treated would reduced the risk by 5% or greater will be eligible for the study.
Additional criteria
- literate
- telephone access
- ablility to utilize the Internet and telemedicine system (after training) Primary Outcome Reduction in Framingham risk index
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
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Framingham risk score equal to or greater than 10%
- •22 -85 years of age
- •access to phone
- •ability to use Internet and system following training
排除标准
- •Class 3 and 4 heart failure
- •stroke with residual disability or dementia
- •unable to read or write
结局指标
主要结局
Framingham 10-year risk index
时间窗: 1 year
次要结局
- Blood pressure, cholesterol, 6 minute walk test, glucose and A1c, CVD knowledge and risk perception(1 year)