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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jacquie Halladay, MD, MPH, University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE August 26, 2011
First Posted Date  ICMJE August 30, 2011
Last Update Posted Date November 19, 2014
Study Start Date  ICMJE September 2011
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2011)
systolic blood pressure [ Time Frame: 2 years ]
We will measures blood pressure at enrollment and then every 6 months for 24 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2011)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Care for Patients With High Blood Pressure
Official Title  ICMJE Heart Healthy Lenoir: Improving Care for Patients With High Blood Pressure
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Cardiovascular Disease Risk
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2013)
535
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2011)
600
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01425515
Other Study ID Numbers  ICMJE 10-0395
P50HL105184 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jacquie Halladay, MD, MPH, University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Jacqueline Halladay, MD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date November 2014

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