Expired Study
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Alexandria, Virginia 22314


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Works in participating company - At least one cardiovascular risk factor Exclusion Criteria: - No known cardiovascular risks


Study is Available At:


Original ID:

535


NCT ID:

NCT00763308


Secondary ID:

R44 HL087540-01


Study Acronym:


Brief Title:

A Web-Based Cardiovascular Intervention for the Workplace


Official Title:

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


Overall Status:

Not yet recruiting


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Heart, Lung, and Blood Institute (NHLBI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

300


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Diane K. Deitz, PhD
Principal Investigator
ISA Associates
Primary Contact:Diane K. Deitz, PhD
ddeitz@isagroup.com

Study Dates

Start Date:April 2009
Completion Date:February 2010
Completion Type:Anticipated
Primary Completion Date:February 2010
Primary Completion Type:Anticipated
Verification Date:September 2008
Last Changed Date:September 26, 2008
First Received Date:September 25, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in cardiovascular risk status
Time Frame:Measured pre- and post-intervention
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change in health attitudes and behaviors
Time Frame:Measured pre- and post-intervention
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Web-based Heart Healthy Program
Description: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.
Arm Name:1

Study Arms

Study Arm Type:No Intervention
Arm Name:2
Description:Participants will receive treatment as usual.
Study Arm Type:Experimental
Arm Name:1
Description:Participants will use the Web-based Heart Healthy program.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Heart, Lung, and Blood Institute (NHLBI)
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:National Institute for Occupational Safety and Health (NIOSH/CDC)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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