Preventing Heart Disease in Underserved Patients

Temple University

Status: Completed

Conditions: Hypertension; Hyperlipidemia; Diabetes Mellitus

Treatments: Behavioral: telemedicine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00778804

4159

Details and patient eligibility

About

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).

Full description

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

Enrollment: 465 patients

Sex: All

Ages: 22 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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465 participants in 2 patient groups

telemedicine

Experimental group

Description:

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

Treatment:

Behavioral: telemedicine

Control

No Intervention group

Description:

Ususal care with quarterly visits