Improving Care for Patients With High Blood Pressure

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jacquie Halladay, MD, MPH, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01425515
First received: August 26, 2011
Last updated: September 5, 2014
Last verified: September 2014
  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: Open Label
Primary Purpose: Treatment
Official Title: Heart Healthy Lenoir: Improving Care for Patients With High Blood Pressure

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • systolic blood pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    We will measures blood pressure at enrollment and then every 6 months for 24 months.


Secondary Outcome Measures:
  • Blood lipids [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A systems approach to developing genomic models integrating clinical and genomic data.


Enrollment: 535
Study Start Date: September 2011
Estimated Study Completion Date: October 2014
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Jacqueline Halladay, MD University of North Carolina, Chapel Hill
  More Information

Additional Information:
Publications:
Additional 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
Study First Received: August 26, 2011
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
hypertension
genomics

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014