Clinical trial NCT00778804: Preventing Heart Disease in Underserved Patients
Official title: Preventing Heart Disease in Underserved Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabetes Mellitus
Hyperlipidemia
Keywords: CVD risk
self monitoring
Internet
telemedicine
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Geisinger Clinic
name: Insight Telehealth Systems
name: Pennsylvania Department of Health
First posted: 2008-10-23
Enrollment: 465
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Framingham 10-year risk index
timeFrame: 1 year
Secondary outcomes:
measure: Blood pressure, cholesterol, 6 minute walk test, glucose and A1c, CVD knowledge and risk perception
timeFrame: 1 year
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hosptial
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Alfred A Bove, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.