Preventing Heart Disease in Underserved Patients

October 22, 2008 updated by: Temple University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

465

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Framingham 10-year risk index
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

Geisinger Clinic
Pennsylvania Department of Health
Insight Telehealth Systems

Investigators

  • Principal Investigator: Alfred A Bove, MD, PhD, Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

October 22, 2008

First Submitted That Met QC Criteria

October 22, 2008

First Posted (Estimate)

October 23, 2008

Study Record Updates

Last Update Posted (Estimate)

October 23, 2008

Last Update Submitted That Met QC Criteria

October 22, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4159

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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