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

NCT00523536 | Completed

• 3 other identifiers: 486U01HL079160U01HL079160-03
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

High Blood Pressure; Cardiovascular

Outcome Measures

Primary Outcomes (1)

• Change in SBP level

  Measured at Year 1

Secondary Outcomes (2)

• 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

  Measured at Year 1

• Utilization of urgent care visits/emergency department/hospitalizations

  Measured at Year 1

Study Arms (2)

1

EXPERIMENTAL

Patient navigator-nurse disease management intervention

Behavioral: Patient Navigator - Nurse Team Intervention

2

NO INTERVENTION

Usual clinical care

Interventions

Patient Navigator - Nurse Team Intervention BEHAVIORAL

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.

1

Eligibility Criteria

• Age: 21 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

East Adult Clinic, Denver Health

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Raymond O. Estacio, MD

  Denver Health, University of Colorado at Denver Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: August 31, 2007
• Study Start: May 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: September 2, 2013

Record last verified: 2009-04

Locations

US (1)