Trial record 5 of 5 for:    Aneurysm | Open Studies | NIH, U.S. Fed

A Web-Based Cardiovascular Intervention for the Workplace

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00763308
First received: September 25, 2008
Last updated: September 26, 2008
Last verified: September 2008
  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.


Condition Intervention Phase
Cardiovascular Diseases
Behavioral: Web-based Heart Healthy Program
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Fast Track Program to Create a Web-Based Cardiovascular Intervention for the Workplace

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Change in health attitudes and behaviors [ Time Frame: Measured pre- and post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in cardiovascular risk status [ Time Frame: Measured pre- and post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: April 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will use the Web-based Heart Healthy program.
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.
No Intervention: 2
Participants will receive treatment as usual.

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Works in participating company
  • At least one cardiovascular risk factor

Exclusion Criteria:

  • No known cardiovascular risks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763308

Contacts
Contact: Diane K. Deitz, PhD ddeitz@isagroup.com

Locations
United States, Virginia
ISA Associates, Inc. Recruiting
Alexandria, Virginia, United States, 22314
Contact: Diane Deitz       ddeitz@isagroup.com   
Sponsors and Collaborators
Investigators
Principal Investigator: Diane K. Deitz, PhD ISA Associates
  More Information

No publications provided

Responsible Party: Diane K. Deitz, PhD, ISA Associates
ClinicalTrials.gov Identifier: NCT00763308     History of Changes
Other Study ID Numbers: 535, R44 HL087540-01
Study First Received: September 25, 2008
Last Updated: September 26, 2008
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Weight
Blood Pressure
Smoking Status
Cardiovascular Risk Profile

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014