Preventing Heart Disease in Underserved Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

465 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-02-28

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).

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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

Conditions

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Hypertension Diabetes Mellitus Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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telemedicine

Web-based monitoring in addition to usual clincial care with quarterly visits

Group Type EXPERIMENTAL

telemedicine

Intervention Type BEHAVIORAL

Weekly transmission of health status (weight, activity, BP etc.) via the Internet with feeedback and reinforcement

Control

Ususal care with quarterly visits

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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telemedicine

Weekly transmission of health status (weight, activity, BP etc.) via the Internet with feeedback and reinforcement

Intervention Type BEHAVIORAL

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