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Improving Care for Patients With High Blood Pressure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01425515
First Posted: August 30, 2011
Last Update Posted: November 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jacquie Halladay, MD, MPH, University of North Carolina, Chapel Hill
  Purpose
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 Intervention
Hypertension Cardiovascular Disease Risk Behavioral: Complex quality improvement intervention

Study Type: Interventional
Study Design: 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

Further study details as provided by Jacquie Halladay, MD, MPH, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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)

  • 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.


Enrollment: 535
Study Start Date: September 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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


Locations
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)
Investigators
Principal Investigator: Jacqueline Halladay, MD University of North Carolina, Chapel Hill
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jacquie Halladay, MD, MPH, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01425515     History of Changes
Other Study ID Numbers: 10-0395
P50HL105184 ( U.S. NIH Grant/Contract )
First Submitted: August 26, 2011
First Posted: August 30, 2011
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Jacquie Halladay, MD, MPH, University of North Carolina, Chapel Hill:
hypertension
genomics

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases


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