NCT00829491

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

3.3 years

First QC Date

January 23, 2009

Last Update Submit

July 13, 2012

Conditions

Keywords

Cardiovascular Disease PreventionBehavior changeRisk Reduction

Outcome Measures

Primary Outcomes (1)

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

    within 12-14months after enrollment

Secondary Outcomes (1)

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

    12-14 months after enrollment

Interventions

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.

Eligibility Criteria

Age30 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Health Authority

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Judith Shlay, MD, MSPH

    Denver Health and Hospital Authority

    PRINCIPAL INVESTIGATOR
  • Christopher Urbina, MD, MPH

    Denver Health and Hospital Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2009

First Posted

January 27, 2009

Study Start

March 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations