CClinicalTrials.gg
CompletedNCT00523536Updated Sep 2, 2013

Evaluation of a Navigator-Nurse Care Team on the Management of High Blood Pressure and Cardiovascular Disease Risk

An interventional study of Patient Navigator - Nurse Team Intervention in Hypertension, sponsored by Denver Health and Hospital Authority. Completed at 1 site in United States. Open to participants aged 21 Years to 74 Years. Per ClinicalTrials.gov, last updated 2013-09-02.

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

Phase
Not applicable
Study type
Interventional
Enrollment
800
Allocation
Randomized
Ages
21 Years to 74 Years
Sex
All
01

Study summary

The purpose of this trial is to study the effect of a patient navigator-nurse team in improving the management of hypertension and other cardiovascular disease risk factors in a health care system taking care of a vulnerable, mostly Latino population.

Read the detailed description

This study represents one phase of a large partnership grant with The Colorado Health Outcomes Program of the University of Colorado at Denver Health Sciences Center (UCDHSC) and Denver Health and Hospital Authority (DH). The overarching goal of Latinos Using Cardio Health Actions to Reduce Risk (LUCHAR) is to improve the primary and secondary prevention of cardiovascular disease (CVD) in Hispanics through a comprehensive research program aimed at (1) increasing awareness of CVD risk in the Hispanic community and increasing participation of high risk Hispanics in the health care system, (2) developing more effective models of care delivery for high risk patients in a health system, and (3) identifying markers that will more effectively identify Hispanic patients at high risk of CVD than current approaches based on traditional risk factors.

This trial has been designed to assess the effectiveness of a quality improvement project which focuses on the hypertensive multiracial underserved population within the Denver Health system. In addition, we are hoping at study end to have developed and validate this project as an efficient and sustainable approach to improving blood pressure control and controlling cardiovascular risk factors, especially in the vulnerable patient population served at Denver Health.

The objective of this quality improvement program is to conduct a randomized, primary care-based, efficacy trial evaluating the effectiveness of a patient navigator-nurse disease management intervention for treating hypertension and its associated cardiovascular risk factors using information obtained in earlier phases of the LUCHAR grant: i.e., algorithms, risk factor profiles, and qualitative data from focus groups and interviews. The study is designed to test the hypothesis that a patient navigator-nurse assisted intervention will improve blood pressure (BP) in vulnerable hypertensive patients, compared with usual clinical care.

02

Conditions studied

  • Hypertension

Keywords

  • High Blood Pressure
  • Cardiovascular
03

In context

Hypertension

6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 800 is above the median of 90 across 4,994 interventional studies indexed under Hypertension.

Browse Hypertension 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
21 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Active patients from the Target Adult Health Clinic
  • Identified with a diagnosis of hypertension
  • Uncontrolled hypertension (2 of 3 last BP measurements above target BP range; target BP is defined at 140/90 or 130/80 mm Hg for people with diabetes or kidney disease)

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding
  • End-stage kidney disease requiring dialysis
  • Co-morbid illness with life expectancy less than 12 months
  • Institutionalized individuals because of the potentially confounding factors due to severe co-morbidity or other medical conditions
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
800 participants (actual)

Study arms

  • Experimental
    1

    Patient navigator-nurse disease management intervention

    Behavioral: Patient Navigator - Nurse Team Intervention

  • No intervention
    2

    Usual clinical care

Interventions

  • BehavioralPatient Navigator - Nurse Team Intervention

    The patient navigator-nurse disease management intervention for treating hypertension and its associated cardiovascular risk factors will use information obtained in earlier phases of the LUCHAR grant: i.e., algorithms, risk factor profiles, and qualitative data from focus groups and interviews. The study will test the effect of this intervention on blood pressure control and utilization of hospital services in adult patients with hypertension.

06

What researchers measure

Primary outcomes

  1. Change in SBP level

    Time frame: Measured at Year 1

Secondary outcomes

  1. Percentage of participants with BP control by JNC-7 guidelines, adherence with BP medications, lipid control, change of HgbA1c for participants with diabetes, and change in smoking status/BMI

    Time frame: Measured at Year 1

  2. Utilization of urgent care visits/emergency department/hospitalizations

    Time frame: Measured at Year 1

07

Study locations

1 site
  • East Adult Clinic, Denver Health
    Denver, Colorado 80204, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00523536
Lead sponsor
Denver Health and Hospital Authority
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of Colorado, Denver
Responsible party
Ed Havranek (Physician, Denver Health and Hospital Authority) — Principal investigator
First posted
Aug 31, 2007
Start date
May 2007
Primary completion
Jun 2009
Completion
Aug 2009
Last update
Sep 2, 2013

Study contacts

Raymond O. Estacio, MD
principal investigator · Denver Health, University of Colorado at Denver Health Sciences Center

Oversight

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

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion