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Improving Care for Patients With High Blood Pressure

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ClinicalTrials.gov Identifier: NCT01425515
Recruitment Status : Completed
First Posted : August 30, 2011
Last Update Posted : November 19, 2014
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jacquie Halladay, MD, MPH, University of North Carolina, Chapel Hill

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Cardiovascular Disease Risk Behavioral: Complex quality improvement intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 535 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Heart Healthy Lenoir: Improving Care for Patients With High Blood Pressure
Study Start Date : September 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Intervention Details:
  • Behavioral: Complex quality improvement intervention
    We are implementing a complex quality improvement intervention that includes changes in practice processes to enhance hypertension care, provision of home blood pressure monitors to patients, and telephone coaching around hypertension self-management.

Primary Outcome Measures :
  1. systolic blood pressure [ Time Frame: 2 years ]
    We will measures blood pressure at enrollment and then every 6 months for 24 months.

Secondary Outcome Measures :
  1. 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. 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)

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425515

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United States, North Carolina
Kinston Enterprise Center - Study Office
Kinston, North Carolina, United States, 28501
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Jacqueline Halladay, MD University of North Carolina, Chapel Hill
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jacquie Halladay, MD, MPH, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01425515    
Other Study ID Numbers: 10-0395
P50HL105184 ( U.S. NIH Grant/Contract )
First Posted: August 30, 2011    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014
Keywords provided by Jacquie Halladay, MD, MPH, University of North Carolina, Chapel Hill:
Additional relevant MeSH terms:
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Cardiovascular Diseases
Vascular Diseases