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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
August 26, 2011
August 30, 2011
November 19, 2014
September 2011
October 2014   (Final data collection date for primary outcome measure)
systolic blood pressure [ Time Frame: 2 years ]
We will measures blood pressure at enrollment and then every 6 months for 24 months.
Same as current
Complete list of historical versions of study NCT01425515 on ClinicalTrials.gov Archive Site
  • 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.
  • Blood lipids [ Time Frame: 2 years ]
    We will measure blood lipids including total cholesterol, HDL, and triglycerides 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 RB, Sr., Vasan RS, Pencina MJ, et al. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. Feb 12 2008;117(6):743-753.
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Improving Care for Patients With High Blood Pressure
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.
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Interventional
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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hypertension
  • Cardiovascular Disease Risk
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
535
October 2014
October 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01425515
10-0395
P50HL105184 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Jacquie Halladay, MD, MPH, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Jacqueline Halladay, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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