Preventing Heart Disease in Underserved Patients
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).
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
Status: Completed (N/A). Started on July 1st, 2004. Ended on February 1st, 2007.
Enrollment: 465 subjects
Study Type: Interventional
Study Design:
- Prevention
- Randomized
- Open Label
- Active Control
- Parallel Assignment
- Efficacy Study
Conditions:
Interventions:
- Behavioral: telemedicine
Eligibility
- Gender
Both
- Mininum Age
22 Years
- Maximum Age
85 Years
- Healthy Volunteers
No
Resources
Source: Temple University
Authority: United States: Institutional Review Board
Locations
-
Temple University Hospital
Philadelphia
Pennsylvania
19140
United States
-
Temple University Hosptial
Philadelphia
Pennsylvania
19140
United States
-
Geisinger Medical Center
Danville
Pennsylvania
17822
United States
Officials
Alfred A Bove, MD, PhD (Principal Investigator, Temple University)
Sponsors
Temple University (Lead Sponsor)
Geisinger Medical Center (Collaborator)
Insight Telehealth Systems (Collaborator)
Pennsylvania Department of Health (Collaborator)
References
None.
Links
None.
- Date Verified
- October 1st, 2008
- First Received
- October 22nd, 2008
- Last Changed
- October 22nd, 2008
Information obtained from ClinicalTrials.gov on October 23, 2008. Link to the current ClinicalTrials.gov record.
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