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CompletedNCT00829491Updated Jul 17, 2012

Denver Health Cardiovascular Disease (CVD) Prevention Program

An interventional study of CVD risk reduction program in Cardiovascular Disease, sponsored by Denver Health and Hospital Authority. Completed at 1 site in United States. Open to participants aged 30 Years to 64 Years. Per ClinicalTrials.gov, last updated 2012-07-17.

Sponsored by Denver Health and Hospital Authority · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
340
Allocation
Not applicable
Ages
30 Years to 64 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cardiovascular Disease

Keywords

  • Cardiovascular Disease Prevention
  • Behavior change
  • Risk Reduction
03

In context

Cardiovascular Diseases

4,902 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

This study's enrollment of 340 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Denver Health and Hospital Authority is the lead sponsor of 84 studies on the registry; 4 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
340 participants (actual)

Interventions

  • BehavioralCVD risk reduction program

    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.

    Also known as: CDPHE, CCPD grants programs.

06

What researchers measure

Primary outcomes

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

    Time frame: within 12-14months after enrollment

Secondary outcomes

  1. Improvement of behavioral and clinical factors that contribute to CVD risk.

    Time frame: 12-14 months after enrollment

07

Study locations

1 site
  • Denver Health Authority
    Denver, Colorado 80204, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00829491
Lead sponsor
Denver Health and Hospital Authority
Collaborators
Colorado Department of Public Health and Environment
Responsible party
Sponsor
First posted
Jan 27, 2009
Start date
Mar 2007
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Jul 17, 2012

Study contacts

Judith Shlay, MD, MSPH
principal investigator · Denver Health and Hospital Authority
Christopher Urbina, MD, MPH
principal investigator · Denver Health and Hospital Authority

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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