Preventing Heart Disease in Underserved Patients
Primary Purpose
Hypertension, Diabetes Mellitus, Hyperlipidemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
telemedicine
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension focused on measuring CVD risk, self monitoring, Internet, telemedicine
Eligibility 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
Sites / Locations
- Geisinger Medical Center
- Temple University Hospital
- Temple University Hosptial
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
telemedicine
Control
Arm Description
Web-based monitoring in addition to usual clincial care with quarterly visits
Ususal care with quarterly visits
Outcomes
Primary Outcome Measures
Framingham 10-year risk index
Secondary Outcome Measures
Blood pressure, cholesterol, 6 minute walk test, glucose and A1c, CVD knowledge and risk perception
Full Information
NCT ID
NCT00778804
First Posted
October 22, 2008
Last Updated
October 22, 2008
Sponsor
Temple University
Collaborators
Geisinger Clinic, Insight Telehealth Systems, Pennsylvania Department of Health
1. Study Identification
Unique Protocol Identification Number
NCT00778804
Brief Title
Preventing Heart Disease in Underserved Patients
Official Title
Preventing Heart Disease in Underserved Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Temple University
Collaborators
Geisinger Clinic, Insight Telehealth Systems, Pennsylvania Department of Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes Mellitus, Hyperlipidemia
Keywords
CVD risk, self monitoring, Internet, telemedicine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
465 (Actual)
8. Arms, Groups, and Interventions
Arm Title
telemedicine
Arm Type
Experimental
Arm Description
Web-based monitoring in addition to usual clincial care with quarterly visits
Arm Title
Control
Arm Type
No Intervention
Arm Description
Ususal care with quarterly visits
Intervention Type
Behavioral
Intervention Name(s)
telemedicine
Intervention Description
Weekly transmission of health status (weight, activity, BP etc.) via the Internet with feeedback and reinforcement
Primary Outcome Measure Information:
Title
Framingham 10-year risk index
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Blood pressure, cholesterol, 6 minute walk test, glucose and A1c, CVD knowledge and risk perception
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfred A Bove, MD, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Temple University Hosptial
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22512287
Citation
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.
Results Reference
derived
PubMed Identifier
21315219
Citation
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.
Results Reference
derived
PubMed Identifier
20436354
Citation
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. Erratum In: J Cardiopulm Rehabil Prev. 2010 Nov-Dec;30(6):373. Kashem, Mohamed [added]; Cross, Robert C [added]; Bove, Alfred A [added].
Results Reference
derived
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Preventing Heart Disease in Underserved Patients
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