Preventing Heart Disease in Underserved Patients

Hypertension Clinical Trial

Official title:

Preventing Heart Disease in Underserved Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778804
• Other study ID #: 4159
• Status: Completed
• Phase: N/A
• First received: October 22, 2008
• Last updated: October 22, 2008
• Start date: July 2004
• Est. completion date: February 2007

Study information

• Verified date: October 2008
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Heart Diseases
• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Temple University Hosptial	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Temple University	Geisinger Clinic, Insight Telehealth Systems, Pennsylvania Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Framingham 10-year risk index		1 year	No
Secondary	Blood pressure, cholesterol, 6 minute walk test, glucose and A1c, CVD knowledge and risk perception		1 year	No