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OpenTrials
Completed

NCT Number: NCT00778804

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).

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Key information

Age range

22 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Medical Center, Danville, Pennsylvania, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine

Behavioral

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

Primary outcomes

  1. Framingham 10-year risk index

    Time frame: 1 year

Secondary outcomes

  1. Blood pressure, cholesterol, 6 minute walk test, glucose and A1c, CVD knowledge and risk perception

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • Geisinger Clinic
  • Insight Telehealth Systems
  • Pennsylvania Department of Health

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Oct 23, 2008
Registry last updated
Oct 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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