Preventing Heart Disease in Underserved Patients

NCT ID: NCT00778804

Last Updated: 2008-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

465 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-02-28

Brief Summary

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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

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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

Conditions

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Hypertension Diabetes Mellitus Hyperlipidemia

Keywords

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CVD risk self monitoring Internet telemedicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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telemedicine

Web-based monitoring in addition to usual clincial care with quarterly visits

Group Type EXPERIMENTAL

telemedicine

Intervention Type BEHAVIORAL

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

Control

Ususal care with quarterly visits

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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telemedicine

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Geisinger Clinic

OTHER

Sponsor Role collaborator

Insight Telehealth Systems

INDUSTRY

Sponsor Role collaborator

Pennsylvania Department of Health

OTHER_GOV

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role lead

Responsible Party

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Pennsylvania Department of Health

Principal Investigators

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Alfred A Bove, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Temple University Hosptial

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Homko CJ, Deeb LC, Rohrbacher K, Mulla W, Mastrogiannis D, Gaughan J, Santamore WP, Bove AA. Impact of a telemedicine system with automated reminders on outcomes in women with gestational diabetes mellitus. Diabetes Technol Ther. 2012 Jul;14(7):624-9. doi: 10.1089/dia.2012.0010. Epub 2012 Apr 18.

Reference Type DERIVED
PMID: 22512287 (View on PubMed)

Bove AA, Santamore WP, Homko C, Kashem A, Cross R, McConnell TR, Shirk G, Menapace F. Reducing cardiovascular disease risk in medically underserved urban and rural communities. Am Heart J. 2011 Feb;161(2):351-9. doi: 10.1016/j.ahj.2010.11.008.

Reference Type DERIVED
PMID: 21315219 (View on PubMed)

McConnell TR, Santamore WP, Larson SL, Homko CJ, Kashem M, Cross RC, Bove AA. Rural and urban characteristics impact cardiovascular risk reduction. J Cardiopulm Rehabil Prev. 2010 Sep-Oct;30(5):299-308. doi: 10.1097/HCR.0b013e3181d6fb82.

Reference Type DERIVED
PMID: 20436354 (View on PubMed)

Other Identifiers

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4159

Identifier Type: -

Identifier Source: org_study_id