Preventing Heart Disease in Underserved Patients

Not Applicable

Completed

• Conditions: Hypertension; Diabetes Mellitus; Hyperlipidemia
• Interventions: Behavioral: telemedicine

• Registration Number: NCT00778804
• Lead Sponsor: Temple University

Brief Summary

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

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

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2008-10
• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-22
• Last Update Submitted: 2008-10-22
• Study First Posted: 2008-10-23
• Last Update Posted: 2008-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 465

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
telemedicine	telemedicine	Web-based monitoring in addition to usual clincial care with quarterly visits

Primary Outcome Measures

Name	Time	Method
Framingham 10-year risk index	1 year

Secondary Outcome Measures

Name	Time	Method
Blood pressure, cholesterol, 6 minute walk test, glucose and A1c, CVD knowledge and risk perception	1 year

Trial Locations

Locations (3)

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Temple University Hosptial; 🇺🇸 Philadelphia, Pennsylvania, United States