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Preventing Heart Disease in Underserved Patients

Preventing Heart Disease in Underserved Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00778804
Enrollment
465
Registered
2008-10-23
Start date
2004-07-31
Completion date
2007-02-28
Last updated
2008-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Hyperlipidemia, Hypertension

Keywords

CVD risk, self monitoring, Internet, telemedicine

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).

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

Interventions

BEHAVIORALtelemedicine

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

Sponsors

Geisinger Clinic
CollaboratorOTHER
Insight Telehealth Systems
CollaboratorINDUSTRY
Pennsylvania Department of Health
CollaboratorOTHER_GOV
Temple University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Framingham 10-year risk index1 year

Secondary

MeasureTime frame
Blood pressure, cholesterol, 6 minute walk test, glucose and A1c, CVD knowledge and risk perception1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026