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Preventing Heart Disease in Underserved Patients

This study has been completed.
Sponsor:
Collaborators:
Geisinger Clinic
Insight Telehealth Systems
Pennsylvania Department of Health
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00778804
First received: October 22, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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 Intervention
Hypertension
Diabetes Mellitus
Hyperlipidemia
 Behavioral: telemedicine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preventing Heart Disease in Underserved Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Temple University:

Primary Outcome Measures:
  • Framingham 10-year risk index [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure, cholesterol, 6 minute walk test, glucose and A1c, CVD knowledge and risk perception [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 465
Study Start Date: July 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   22 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Temple University

Additional 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
Study First Received: October 22, 2008
Last Updated: October 22, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013