A Web-Based Cardiovascular Intervention for the Workplace

Cardiovascular Diseases Clinical Trial

Official title:

Fast Track Program to Create a Web-Based Cardiovascular Intervention for the Workplace

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00763308
• Other study ID #: 535
• Secondary ID: R44HL087540-01
• Status: Not yet recruiting
• Phase: Phase 1
• First received: September 25, 2008
• Last updated: September 26, 2008
• Start date: April 2009
• Est. completion date: February 2010

Study information

• Verified date: September 2008
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: Diane K. Deitz, PhD
• Email: ddeitz[@]isagroup.com
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Heart disease is the leading cause of death in the United States, accounting for approximately 700,000 deaths a year. Heart disease can take many forms, including heart attacks, coronary artery disease, aneurysms, high blood pressure, and strokes. However, people can change things in their life to reduce the risk of getting heart disease. This study will first create an Internet-based program to help teach people about reducing heart disease risk and will then test the program in a workplace setting.

Description:

Heart disease, or cardiovascular disease, refers to a range of diseases including coronary artery disease, heart attack, heart failure, high blood pressure, and stroke. These diseases are all related to problems with the heart and blood vessels, and collectively are the leading cause of death in the United States. Heart attacks or coronary artery disease sometimes have warning signs, but both can occur without warning. Approximately half of all heart attacks are fatal. Forty percent of all deaths in the United States are the result of heart disease.

Certain factors can predict whether people get heart disease. Some of these factors, like biological sex or genes inherited from a person's family, cannot be changed, but many others can. Not smoking, eating well, exercising regularly, and maintaining a healthy weight are some of the things people can do to lower their risk of heart disease. This study will develop and then test an Internet-based program that teaches people about heart health and supports them in changing behaviors that put them at risk for heart disease.

This study will be divided into two phases. In the first phase, researchers will create the Heart Healthy program, show it to focus groups, and try to improve it based on their comments. The goals of the program are to educate users in the fundamentals of heart health and risk factors for heart disease and to provide a system for starting and sustaining lifestyle changes that reduce risk of heart disease. The program will be designed for employee use in a workplace, and a tool kit will be developed for managers to supplement the employee program. The prototype will include modified segments from existing Web-based programs created by a non-profit organization, the ISA Group. The design of the program will be guided by feedback from employees and managers who use it and from experts in cardiology and epidemiology.

In the second phase, the program will be tested in a work site. Employees at risk for heart disease will be recruited and randomly assigned to receive either the Healthy Heart program or treatment as usual. Before and after the intervention, participants will be assessed on knowledge gained, attitudes changed, alterations in health behavior, and reductions in cardiovascular risk. Managers who receive the supplementary program will be tested in knowledge gained and plans for policy or procedural changes. The ultimate goal of this phase is to fully develop the Healthy Heart program for use in industry and health care settings.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Works in participating company

• At least one cardiovascular risk factor

Exclusion Criteria:

• No known cardiovascular risks

Study Design

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Web-based Heart Healthy Program
The Heart Healthy program will be developed during the course of the study based on goals set by researchers and based on feedback from focus groups. The goals of the program are to educate users in the fundamentals of heart health and risk factors for heart disease and to provide a system for starting and sustaining lifestyle changes that reduce risk of heart disease.

Locations

Country	Name	City	State
United States	ISA Associates, Inc.	Alexandria	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)	National Institute for Occupational Safety and Health (NIOSH/CDC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in health attitudes and behaviors		Measured pre- and post-intervention	No
Secondary	Change in cardiovascular risk status		Measured pre- and post-intervention	No