NCT00778804

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
465

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Jul 2004

Typical duration for not_applicable hypertension

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
Last Updated

October 23, 2008

Status Verified

October 1, 2008

Enrollment Period

2.6 years

First QC Date

October 22, 2008

Last Update Submit

October 22, 2008

Conditions

HypertensionDiabetes MellitusHyperlipidemia

Keywords

CVD riskself monitoringInternettelemedicine

Outcome Measures

Primary Outcomes (1)

  • Framingham 10-year risk index

    1 year

Secondary Outcomes (1)

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

    1 year

Study Arms (2)

telemedicine

EXPERIMENTAL

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

Behavioral: telemedicine

Control

NO INTERVENTION

Ususal care with quarterly visits

Interventions

telemedicineBEHAVIORAL

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

telemedicine

Eligibility Criteria

Age22 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Framingham risk score equal to or greater than 10%
  • literacy
  • years of age
  • access to phone
  • ability to use Internet and system following training

You may not qualify if:

  • Class 3 and 4 heart failure
  • ESRD
  • stroke with residual disability or dementia
  • unable to read or write

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Temple University Hosptial

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (3)

  • 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.

    PMID: 22512287DERIVED

  • 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.

    PMID: 21315219DERIVED

  • 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.

    PMID: 20436354DERIVED

MeSH Terms

Conditions

HypertensionDiabetes MellitusHyperlipidemias

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDyslipidemiasLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Alfred A Bove, MD, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 23, 2008

Study Start

July 1, 2004

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

October 23, 2008

Record last verified: 2008-10

Locations

US(3)