Preventing Heart Disease in Underserved Patients

Study Overview
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Brief Summary
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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).

Detailed Description
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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

Official Title
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Preventing Heart Disease in Underserved Patients

Conditions
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Hypertension, Diabetes Mellitus, Hyperlipidemia

Intervention / Treatment
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* Behavioral: telemedicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Framingham risk score equal to or greater than 10% literacy 22 -85 years of age access to phone ability to use Internet and system following training Exclusion Criteria: Class 3 and 4 heart failure ESRD stroke with residual disability or dementia unable to read or write

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: telemedicine<br>Web-based monitoring in addition to usual clincial care with quarterly visits | Behavioral: telemedicine<br>* Weekly transmission of health status (weight, activity, BP etc.) via the Internet with feeedback and reinforcement<br>|
| No Intervention: Control<br>Ususal care with quarterly visits | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Framingham 10-year risk index |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure, cholesterol, 6 minute walk test, glucose and A1c, CVD knowledge and risk perception |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CVD risk, self monitoring, Internet, telemedicine