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Cardiovascular DiseaseNCT00829491

Denver Health Cardiovascular Disease (CVD) Prevention Program

A study testing CVD risk reduction program in people with Cardiovascular Disease, run by Denver Health and Hospital Authority at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of the Denver Health CVD Prevention Program is to assess the effectiveness of developing an enhanced cardiovascular disease prevention program in a community health care setting. Read more about this study

Who is it for?
Ages 30 to 64 years
Conditions the study is for
Cardiovascular Disease
What is being tested?
CVD risk reduction program
How many people
340 participants
Where
1 siteUnited States
Study dates
Mar 2007to Jun 2010
Phase
Interventional
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 30 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • We will include English or Spanish-speaking individuals between the ages of 30-64 years who actively utilize one of the three community health centers, La Casa Quigg-Newton Family Health Center, the Family and Internal Medicine clinic at the Wellington E. Webb Center for Primary Care, and Westside Neighborhood Health Center for primary care and who have a FRS of 10% or greater. Active utilization will be defined as having 2 or more visits within the past 18 months.

Who cannot join

  • We will exclude pregnant or lactating women, any patient with a prior history of cardiovascular disease (using ICD-9 codes), and/or any patient with a co-morbid illness whose life expectancy less than 12 months (e.g., terminal cancer).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Denver Health Authority

    Denver, Colorado, 80204

Other trials in United States

About this study

Official title: Denver Health Cardiovascular Prevention Program

The objective of the Denver Health CVD Prevention Program is to assess the effectiveness of developing an enhanced cardiovascular disease prevention program in a community health care setting.

Read the detailed description

Cardiovascular disease (CVD) is the leading cause of mortality in Colorado.[1] This is especially true in the Latino population who are at greater risk for CVD compared to non-Latino whites, and suffer more premature CVD deaths.[2] Among persons less than 34 years, Latinos are four times more likely to die from heart disease than non-Latino whites, a disparity that lessens but does not disappear with age (1.5 ratios among persons 55 - 64 yrs old). Recently, the INTERHEART study demonstrated that 90% of the population attributable risk is due to established modifiable risk factors (smoking, dyslipidemia, hypertension, diabetes, obesity, psychosocial factors, daily consumption of fruits and vegetables, regular alcohol consumption and regular physical activity).[3] Many individuals in the general population have one or more risk factors for CVD and over 90% of CVD events occur in individuals with at least one risk factor,[3, 4] with few events occurring in individuals with no risk factors, thus supporting the notion of focusing prevention activities on individuals at higher risk for CVD.

Reducing the risk of CVD is part of Colorado's strategic plan. Programs are needed that offer provide enhanced patient-centered CVD prevention services using paraprofessionals and thus assisting health care providers (i.e., physicians, midlevels) in addressing preventive health care issues. Early identification of CVD risk is paramount in order to reach those who need the appropriate treatment. In this regard, NCEP guidelines recommend the utilization of the Framingham Risk Score (FRS) as the basis to identify patients with an increased 10-year risk for CVD events.

Despite evidence of the effectiveness of preventive services and the development of published national guidelines,[5, 6] rates of delivery of preventive services remain low.[7] The most common barriers identified are the lack of time during the office visit, inadequate insurance reimbursement, patient refusal to discuss or comply with recommendations, and lack of physician expertise in counseling techniques.[8-12] At Denver Community Health Services (DCHS), a department of Denver Health (DH), an additional barrier includes socioeconomic issues associated with a low-income population with ethnically diverse issues. Thus, delivering CVD preventive services often takes a lower priority during an office visit in a busy clinical practice. However, proactively identifying individuals at risk of CVD and involving them in their own care should increase awareness of CVD risk factors and as such assist in reducing the burden of CVD in the community.

Denver Public Health (DPH) in collaboration with DCHS will implement a comprehensive cardiovascular risk assessment and prevention treatment plan among three westside community health centers. In order to improve CVD risk reduction, this demonstration project will a) develop a CVD registry to be able to identify at risk individuals, b) engage high-risk patients to participate in CVD prevention activities, c) implement a series of evidence-based prevention strategies to be offered in the clinic and community, d) perform both process and outcome evaluations of this demonstration project, and e) compare biologic results (e.g., FRS, lipid levels) with sites not participating in the intervention to assess the effectiveness of our intervention.

Being tested
CVD risk reduction program
Keywords
Cardiovascular Disease Prevention, Behavior change, Risk Reduction
Medical subject headings
Cardiovascular Diseases, Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CVD risk reduction programBehavioural

    Also called CDPHE, CCPD grants programs.

    Participants will be selected through review of the DH administrative databases or by referral from their primary care provider. After completion of the forms, the navigator and client will discuss potential CVD risk reduction activities and programs available through this program for the client to participate in. Potential activities will include self-monitoring using self-help tools,healthy nutrition and exercise activities, community-based exercise programs using the recreation centers in the community, and referral to the Colorado Quitline for smoking cessation activities. Follow-up questionnaires will be completed at 6 and 12 months after enrollment to assess changes in levels of exercise, dietary patterns, and beliefs and attitudes about behavioral change.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of CVD risk as measured by Framingham risk score.

    Measured: within 12-14months after enrollment

Secondary outcomes (1)
  1. Improvement of behavioral and clinical factors that contribute to CVD risk.

    Measured: 12-14 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2009 (estimated)
  2. Study startMar 2007
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

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 N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00829491
Sponsor's protocol ID
07-0020
Status last verified
Jul 2012
First submitted
23 Jan 2009
Last updated
17 Jul 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing CVD risk reduction program in people with Cardiovascular Disease, run by Denver Health and Hospital Authority 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 1 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: finished, as of the sponsor's last update on 17 Jul 2012. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of CVD risk as measured by Framingham risk score. (time frame: within 12-14months after enrollment). 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 17 Jul 2012.

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