Improving Care for Patients With High Blood Pressure

November 17, 2014 updated by: Jacquie Halladay, MD, MPH, University of North Carolina, Chapel Hill

Heart Healthy Lenoir: Improving Care for Patients With High Blood Pressure

The investigators are conducting a single group intervention study to improve blood pressure control and reduce racial and literacy related disparities among people with hypertension. The intervention includes providing patients with home blood pressure monitors, administering phone-coaching to participants, and improving hypertension care at the participating practices from which patients are enrolled. The investigators will follow the patients for 2 years to determine if blood pressure control improves. In addition, the project will explore genetic factors associated with cardiovascular disease risk and treatment success.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

535

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Kinston, North Carolina, United States, 28501
        • Kinston Enterprise Center - Study Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women who meet the following inclusion criteria will be eligible for study participation:
  • 18 years or older,
  • Able and willing to give informed consent,
  • A current patient of 1 of the 5 participating practices,
  • Have a current diagnosis of hypertension by their primary care physician or have 3 documented blood pressures above 150/90,
  • Their most recent systolic blood pressure was greater than or equal to 150 at their most recent clinic visit,
  • Receive physician approval to participate in the study.
  • Anyone enrolled in the High Blood Pressure study is eligible to participate in the genomics component of the project.

Exclusion Criteria:

  • non-English speaking,
  • current treatment of psychosis,
  • diagnosed with advanced dementia as determined by the clinician,
  • current substance abuse,
  • lack of phone access,
  • history of malignancy, other than non-melanoma skin cancer, that has not been in remission or cured surgically for > 5 years,
  • estimated creatinine clearance less than 30 ml/min (because hypertension management becomes more complicated at this point),
  • are pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
systolic blood pressure
Time Frame: 2 years
We will measures blood pressure at enrollment and then every 6 months for 24 months.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood lipids
Time Frame: 2 years
We will measure blood lipids including total cholesterol and HDL over the course of the study to calculate overall cardiovascular risk.
2 years
General Cardiovascular Disease Risk
Time Frame: 2 years
We will measure variables (blood pressure, cholesterol, aspirin use, smoking status, and diabetes status) to calculate general cardiovascular disease risk which includes (coronary death, myocardial infarction, coronary insufficiency, angina, ischemic stroke, hemorrhagic stroke, transient ischemic attack, peripheral artery disease, heart failure). (D'Agostino, 2008)
2 years
Genomic predictors of blood pressure change
Time Frame: 6-, 12-, 18, and 24-month follow-up
A systems approach to developing genomic models integrating clinical and genomic data.
6-, 12-, 18, and 24-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Jacqueline Halladay, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 26, 2011

First Submitted That Met QC Criteria

August 29, 2011

First Posted (Estimate)

August 30, 2011

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-0395
  • P50HL105184 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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