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Preventing Heart Disease in Underserved Patients

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ClinicalTrials.gov Identifier: NCT00778804
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : October 23, 2008
Sponsor:
Collaborators:
Geisinger Clinic
Insight Telehealth Systems
Pennsylvania Department of Health
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Hypertension Diabetes Mellitus Hyperlipidemia Behavioral: telemedicine Not Applicable

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  (Clinical Trial)
Actual Enrollment : 465 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Heart Disease in Underserved Patients
Study Start Date : July 2004
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Framingham 10-year risk index [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Blood pressure, cholesterol, 6 minute walk test, glucose and A1c, CVD knowledge and risk perception [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00778804


Locations
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Temple University Hosptial
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Geisinger Clinic
Insight Telehealth Systems
Pennsylvania Department of Health
Investigators
Principal Investigator: Alfred A Bove, MD, PhD Temple University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Catherine Becker, Pennsylvania Department of Health
ClinicalTrials.gov Identifier: NCT00778804     History of Changes
Other Study ID Numbers: 4159
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: October 23, 2008
Last Verified: October 2008

Keywords provided by Temple University:
CVD risk
self monitoring
Internet
telemedicine

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Diseases
Hyperlipidemias
Hyperlipoproteinemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders