Cardiovascular DiseasesPhase 1NCT00763308
A Web-Based Cardiovascular Intervention for the Workplace
A Phase 1 study testing Web-based Heart Healthy Program in people with Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Web-based Heart Healthy Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Feb 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Works in participating company
- At least one cardiovascular risk factor
Who cannot join
- No known cardiovascular risks
Trial locations and contacts
1 site in 1 country.
Diane K. Deitz, PhD contact
United States1 site
ISA Associates, Inc.
Alexandria, Virginia, 22314
Diane Deitz, ddeitz@isagroup.com
About this study
Official title: Fast Track Program to Create a Web-Based Cardiovascular Intervention for the Workplace
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Web-based Heart Healthy Program
- Keywords
- Weight, Blood Pressure, Smoking Status, Cardiovascular Risk Profile
- Medical subject headings
- Cardiovascular Diseases, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based Heart Healthy ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will use the Web-based Heart Healthy program. Receives: Behavioral: Web-based Heart Healthy Program |
| 2 | No intervention | Participants will receive treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health attitudes and behaviors
Measured: Measured pre- and post-intervention
Secondary outcomes (1)
Change in cardiovascular risk status
Measured: Measured pre- and post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startApr 2009
- Primary completionFeb 2010 (estimated)
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Investigators
- Diane K. Deitz, PhD, Principal investigator, ISA Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763308
- Sponsor's protocol ID
- 535
- Other IDs
- R44HL087540-01
- Status last verified
- Sep 2008
- First submitted
- 25 Sep 2008
- Last updated
- 30 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Track Program to Create a Web-Based Cardiovascular Intervention for the Workplace
- ClinicalTrials.gov ID
- NCT00763308
- Acronym / sponsor ID
- 535
- Conditions
- Cardiovascular Diseases
- Keywords
- Weight, Blood Pressure, Smoking Status, Cardiovascular Risk Profile
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- Apr 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Web-based Heart Healthy ProgramParticipants will use the Web-based Heart Healthy program. |
| 2 | No intervention | –Participants will receive treatment as usual. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Works in participating company
- At least one cardiovascular risk factor
Key exclusion criteria (1 listed)
- No known cardiovascular risks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based Heart Healthy ProgramThe 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. | Behavioural | 1 |
Primary outcome
Change in health attitudes and behaviors
Time frame: Measured pre- and post-intervention
1 secondary outcome
Change in cardiovascular risk status
Time frame: Measured pre- and post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane K. Deitz, PhD contact
Diane K. Deitz, PhD principal investigator
ISA Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Web-based Heart Healthy Program in people with Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diane K. Deitz, PhD (ddeitz@isagroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health attitudes and behaviors (time frame: Measured pre- and post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2008.